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Understanding De-Implementation of Low Value Castration for Men With Prostate Cancer

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RESEARCH OBJECTIVE: Men with prostate cancer are often treated with androgen deprivation therapy (ADT). While ADT monotherapy is not appropriate treatment for most localized prostate cancer, it continues to be used raising questions of low-value care. Guided by the Theoretical Domains Framework (TDF) and the Behavior Change Wheel’s Capability, Opportunity, Motivation Model (COM-B), we conducted a qualitative study to identify determinants of low value ADT use and opportunities for de-implementation strategy development.

STUDY DESIGN: We used VA national cancer registry and administrative data from 2016-2017 to select facilities with the highest and lowest rates of ADT monotherapy as localized prostate cancer treatment. We used purposive sampling to select high and low performing sites and complete and code 20 provider interviews from 14 facilities across the nation (17 high and 3 low ADT use sites). Next, we mapped TDF domains to the COM-B Model to generate a conceptual framework of provider approaches to low value ADT.

PRINCIPAL FINDINGS: Based on emerging behavioral themes, our conceptual model characterized 3 groups of providers based on low value ADT use: (1) never prescribe; (2) willing, under some circumstances, to prescribe; and (3) routinely prescribe as an acceptable treatment option. Providers in all groups demonstrated strengths in the Capability domain, such as knowledge of appropriate localized prostate cancer treatment options (knowledge), coupled with interpersonal skills to engage patients in educational discussion (skills). Motivation to prescribe low value ADT depended on goals of care, including patient preferences (goals), view of their role (beliefs in capabilities/professional role and identity), and beliefs about benefits and harms ADT would afford patients (beliefs about consequences). In the Opportunity domain, access to resources, such as guidelines and interdisciplinary colleagues (environmental resources) and advice of peers (social influences) were influential factors in providers’ decision- making about low value ADT prescribing.

CONCLUSIONS: Behavioral theory-based characterization of provider practices helps clarify determinants implicated in provider decisions to prescribe low value ADT.

IMPLICATIONS: Identifying behavioral determinants impacting provider decisions to prescribe low value ADT informs theory-based de-implementation strategy development, and serves as a model to decrease low-value care more broadly.

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RESEARCH OBJECTIVE: Men with prostate cancer are often treated with androgen deprivation therapy (ADT). While ADT monotherapy is not appropriate treatment for most localized prostate cancer, it continues to be used raising questions of low-value care. Guided by the Theoretical Domains Framework (TDF) and the Behavior Change Wheel’s Capability, Opportunity, Motivation Model (COM-B), we conducted a qualitative study to identify determinants of low value ADT use and opportunities for de-implementation strategy development.

STUDY DESIGN: We used VA national cancer registry and administrative data from 2016-2017 to select facilities with the highest and lowest rates of ADT monotherapy as localized prostate cancer treatment. We used purposive sampling to select high and low performing sites and complete and code 20 provider interviews from 14 facilities across the nation (17 high and 3 low ADT use sites). Next, we mapped TDF domains to the COM-B Model to generate a conceptual framework of provider approaches to low value ADT.

PRINCIPAL FINDINGS: Based on emerging behavioral themes, our conceptual model characterized 3 groups of providers based on low value ADT use: (1) never prescribe; (2) willing, under some circumstances, to prescribe; and (3) routinely prescribe as an acceptable treatment option. Providers in all groups demonstrated strengths in the Capability domain, such as knowledge of appropriate localized prostate cancer treatment options (knowledge), coupled with interpersonal skills to engage patients in educational discussion (skills). Motivation to prescribe low value ADT depended on goals of care, including patient preferences (goals), view of their role (beliefs in capabilities/professional role and identity), and beliefs about benefits and harms ADT would afford patients (beliefs about consequences). In the Opportunity domain, access to resources, such as guidelines and interdisciplinary colleagues (environmental resources) and advice of peers (social influences) were influential factors in providers’ decision- making about low value ADT prescribing.

CONCLUSIONS: Behavioral theory-based characterization of provider practices helps clarify determinants implicated in provider decisions to prescribe low value ADT.

IMPLICATIONS: Identifying behavioral determinants impacting provider decisions to prescribe low value ADT informs theory-based de-implementation strategy development, and serves as a model to decrease low-value care more broadly.

RESEARCH OBJECTIVE: Men with prostate cancer are often treated with androgen deprivation therapy (ADT). While ADT monotherapy is not appropriate treatment for most localized prostate cancer, it continues to be used raising questions of low-value care. Guided by the Theoretical Domains Framework (TDF) and the Behavior Change Wheel’s Capability, Opportunity, Motivation Model (COM-B), we conducted a qualitative study to identify determinants of low value ADT use and opportunities for de-implementation strategy development.

STUDY DESIGN: We used VA national cancer registry and administrative data from 2016-2017 to select facilities with the highest and lowest rates of ADT monotherapy as localized prostate cancer treatment. We used purposive sampling to select high and low performing sites and complete and code 20 provider interviews from 14 facilities across the nation (17 high and 3 low ADT use sites). Next, we mapped TDF domains to the COM-B Model to generate a conceptual framework of provider approaches to low value ADT.

PRINCIPAL FINDINGS: Based on emerging behavioral themes, our conceptual model characterized 3 groups of providers based on low value ADT use: (1) never prescribe; (2) willing, under some circumstances, to prescribe; and (3) routinely prescribe as an acceptable treatment option. Providers in all groups demonstrated strengths in the Capability domain, such as knowledge of appropriate localized prostate cancer treatment options (knowledge), coupled with interpersonal skills to engage patients in educational discussion (skills). Motivation to prescribe low value ADT depended on goals of care, including patient preferences (goals), view of their role (beliefs in capabilities/professional role and identity), and beliefs about benefits and harms ADT would afford patients (beliefs about consequences). In the Opportunity domain, access to resources, such as guidelines and interdisciplinary colleagues (environmental resources) and advice of peers (social influences) were influential factors in providers’ decision- making about low value ADT prescribing.

CONCLUSIONS: Behavioral theory-based characterization of provider practices helps clarify determinants implicated in provider decisions to prescribe low value ADT.

IMPLICATIONS: Identifying behavioral determinants impacting provider decisions to prescribe low value ADT informs theory-based de-implementation strategy development, and serves as a model to decrease low-value care more broadly.

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The Impact of Sequencing of Abiraterone and Enzalutamide in Veterans With Metastatic Castration- Resistant Prostate Cancer

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PURPOSE: To evaluate outcomes of disease progression based on the sequence of abiraterone and enzalutamide in veterans diagnosed with metastatic castration-resistant prostate cancer (mCRPC). BACKGROUND: Two of the current options for mCRPC treatment are the novel oral hormonal agents abiraterone and enzalutamide. After progression on one of these agents, one option is to switch to the other agent not previously used. Previously published retrospective studies and one prospective study have shown a difference in outcomes favoring abiraterone followed by enzalutamide, while others have shown no difference based on sequence. The optimal sequence of abiraterone and enzalutamide is still unclear.

METHODS: This was a retrospective chart review of patients who received abiraterone and enzalutamide in sequence for the treatment of mCRPC within our healthcare system from April 28, 2011 through October 31, 2019. Baseline demographic information such as age, race, Gleason score, and prior treatments were collected. The primary outcome was combined prostate-specific antigen progression-free survival (cPSA-PFS). Secondary outcomes included radiographic PFS (rPFS), overall survival (OS), adverse events causing treatment discontinuation, and medication adherence. Between-group survival differences were estimated by the Kaplan-Meier method and an unadjusted Cox regression model.

RESULTS: A total of 77 patients met criteria for study inclusion, with 51 in the abiraterone-to-enzalutamide group (ABI-ENZ) and 26 in the enzalutamide-to-abiraterone group (ENZ-ABI). For the primary outcome of cPSA-PFS, the median survival of the ABI-ENZ and ENZ-ABI groups was 17.3 months (95% CI, 10.3-24.3 months) and 10.2 months (95% CI, 8.5-11.8 months), respectively, which was significantly different (log-rank P=0.009) in favor of the ABI-ENZ sequence (HR 0.46; 95% CI, 0.26-0.83). Secondary outcomes of rPFS and OS were not significantly different between groups.

CONCLUSION: This study adds to the evidence supporting the sequence of abiraterone before enzalutamide for improving PSA-PFS. It is thought this might be related to differences in mechanisms of resistance between the two drugs. This benefit has not yet translated to an improvement in rPFS and OS. Based on the results of this study in conjunction with previously published studies, use of abiraterone before enzalutamide should be considered over the alternate sequence.

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PURPOSE: To evaluate outcomes of disease progression based on the sequence of abiraterone and enzalutamide in veterans diagnosed with metastatic castration-resistant prostate cancer (mCRPC). BACKGROUND: Two of the current options for mCRPC treatment are the novel oral hormonal agents abiraterone and enzalutamide. After progression on one of these agents, one option is to switch to the other agent not previously used. Previously published retrospective studies and one prospective study have shown a difference in outcomes favoring abiraterone followed by enzalutamide, while others have shown no difference based on sequence. The optimal sequence of abiraterone and enzalutamide is still unclear.

METHODS: This was a retrospective chart review of patients who received abiraterone and enzalutamide in sequence for the treatment of mCRPC within our healthcare system from April 28, 2011 through October 31, 2019. Baseline demographic information such as age, race, Gleason score, and prior treatments were collected. The primary outcome was combined prostate-specific antigen progression-free survival (cPSA-PFS). Secondary outcomes included radiographic PFS (rPFS), overall survival (OS), adverse events causing treatment discontinuation, and medication adherence. Between-group survival differences were estimated by the Kaplan-Meier method and an unadjusted Cox regression model.

RESULTS: A total of 77 patients met criteria for study inclusion, with 51 in the abiraterone-to-enzalutamide group (ABI-ENZ) and 26 in the enzalutamide-to-abiraterone group (ENZ-ABI). For the primary outcome of cPSA-PFS, the median survival of the ABI-ENZ and ENZ-ABI groups was 17.3 months (95% CI, 10.3-24.3 months) and 10.2 months (95% CI, 8.5-11.8 months), respectively, which was significantly different (log-rank P=0.009) in favor of the ABI-ENZ sequence (HR 0.46; 95% CI, 0.26-0.83). Secondary outcomes of rPFS and OS were not significantly different between groups.

CONCLUSION: This study adds to the evidence supporting the sequence of abiraterone before enzalutamide for improving PSA-PFS. It is thought this might be related to differences in mechanisms of resistance between the two drugs. This benefit has not yet translated to an improvement in rPFS and OS. Based on the results of this study in conjunction with previously published studies, use of abiraterone before enzalutamide should be considered over the alternate sequence.

PURPOSE: To evaluate outcomes of disease progression based on the sequence of abiraterone and enzalutamide in veterans diagnosed with metastatic castration-resistant prostate cancer (mCRPC). BACKGROUND: Two of the current options for mCRPC treatment are the novel oral hormonal agents abiraterone and enzalutamide. After progression on one of these agents, one option is to switch to the other agent not previously used. Previously published retrospective studies and one prospective study have shown a difference in outcomes favoring abiraterone followed by enzalutamide, while others have shown no difference based on sequence. The optimal sequence of abiraterone and enzalutamide is still unclear.

METHODS: This was a retrospective chart review of patients who received abiraterone and enzalutamide in sequence for the treatment of mCRPC within our healthcare system from April 28, 2011 through October 31, 2019. Baseline demographic information such as age, race, Gleason score, and prior treatments were collected. The primary outcome was combined prostate-specific antigen progression-free survival (cPSA-PFS). Secondary outcomes included radiographic PFS (rPFS), overall survival (OS), adverse events causing treatment discontinuation, and medication adherence. Between-group survival differences were estimated by the Kaplan-Meier method and an unadjusted Cox regression model.

RESULTS: A total of 77 patients met criteria for study inclusion, with 51 in the abiraterone-to-enzalutamide group (ABI-ENZ) and 26 in the enzalutamide-to-abiraterone group (ENZ-ABI). For the primary outcome of cPSA-PFS, the median survival of the ABI-ENZ and ENZ-ABI groups was 17.3 months (95% CI, 10.3-24.3 months) and 10.2 months (95% CI, 8.5-11.8 months), respectively, which was significantly different (log-rank P=0.009) in favor of the ABI-ENZ sequence (HR 0.46; 95% CI, 0.26-0.83). Secondary outcomes of rPFS and OS were not significantly different between groups.

CONCLUSION: This study adds to the evidence supporting the sequence of abiraterone before enzalutamide for improving PSA-PFS. It is thought this might be related to differences in mechanisms of resistance between the two drugs. This benefit has not yet translated to an improvement in rPFS and OS. Based on the results of this study in conjunction with previously published studies, use of abiraterone before enzalutamide should be considered over the alternate sequence.

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The Impact of Sequencing of Abiraterone and Enzalutamide in Veterans With Metastatic Castration- Resistant Prostate Cancer

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PURPOSE: To evaluate outcomes of disease progression based on the sequence of abiraterone and enzalutamide in veterans diagnosed with metastatic castration-resistant prostate cancer (mCRPC).

BACKGROUND: Two of the current options for mCRPC treatment are the novel oral hormonal agents abiraterone and enzalutamide. After progression on one of these agents, one option is to switch to the other agent not previously used. Previously published retrospective studies and one prospective study have shown a difference in outcomes favoring abiraterone followed by enzalutamide, while others have shown no difference based on sequence. The optimal sequence of abiraterone and enzalutamide is still unclear.

METHODS: This was a retrospective chart review of patients who received abiraterone and enzalutamide in sequence for the treatment of mCRPC within our healthcare system from April 28, 2011 through October 31, 2019. Baseline demographic information such as age, race, Gleason score, and prior treatments were collected. The primary outcome was combined prostate-specific antigen progression-free survival (cPSA-PFS). Secondary outcomes included radiographic PFS (rPFS), overall survival (OS), adverse events causing treatment discontinuation, and medication adherence. Between-group survival differences were estimated by the Kaplan-Meier method and an unadjusted Cox regression model.

RESULTS: A total of 77 patients met criteria for study inclusion, with 51 in the abiraterone-to-enzalutamide group (ABI-ENZ) and 26 in the enzalutamide-to-abiraterone group (ENZ-ABI). For the primary outcome of cPSA-PFS, the median survival of the ABI-ENZ and ENZ-ABI groups was 17.3 months (95% CI, 10.3-24.3 months) and 10.2 months (95% CI, 8.5-11.8 months), respectively, which was significantly different (log-rank P=0.009) in favor of the ABI-ENZ sequence (HR 0.46; 95% CI, 0.26-0.83). Secondary outcomes of rPFS and OS were not significantly different between groups.

CONCLUSION: This study adds to the evidence supporting the sequence of abiraterone before enzalutamide for improving PSA-PFS. It is thought this might be related to differences in mechanisms of resistance between the two drugs. This benefit has not yet translated to an improvement in rPFS and OS. Based on the results of this study in conjunction with previously published studies, use of abiraterone before enzalutamide should be considered over the alternate sequence.

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PURPOSE: To evaluate outcomes of disease progression based on the sequence of abiraterone and enzalutamide in veterans diagnosed with metastatic castration-resistant prostate cancer (mCRPC).

BACKGROUND: Two of the current options for mCRPC treatment are the novel oral hormonal agents abiraterone and enzalutamide. After progression on one of these agents, one option is to switch to the other agent not previously used. Previously published retrospective studies and one prospective study have shown a difference in outcomes favoring abiraterone followed by enzalutamide, while others have shown no difference based on sequence. The optimal sequence of abiraterone and enzalutamide is still unclear.

METHODS: This was a retrospective chart review of patients who received abiraterone and enzalutamide in sequence for the treatment of mCRPC within our healthcare system from April 28, 2011 through October 31, 2019. Baseline demographic information such as age, race, Gleason score, and prior treatments were collected. The primary outcome was combined prostate-specific antigen progression-free survival (cPSA-PFS). Secondary outcomes included radiographic PFS (rPFS), overall survival (OS), adverse events causing treatment discontinuation, and medication adherence. Between-group survival differences were estimated by the Kaplan-Meier method and an unadjusted Cox regression model.

RESULTS: A total of 77 patients met criteria for study inclusion, with 51 in the abiraterone-to-enzalutamide group (ABI-ENZ) and 26 in the enzalutamide-to-abiraterone group (ENZ-ABI). For the primary outcome of cPSA-PFS, the median survival of the ABI-ENZ and ENZ-ABI groups was 17.3 months (95% CI, 10.3-24.3 months) and 10.2 months (95% CI, 8.5-11.8 months), respectively, which was significantly different (log-rank P=0.009) in favor of the ABI-ENZ sequence (HR 0.46; 95% CI, 0.26-0.83). Secondary outcomes of rPFS and OS were not significantly different between groups.

CONCLUSION: This study adds to the evidence supporting the sequence of abiraterone before enzalutamide for improving PSA-PFS. It is thought this might be related to differences in mechanisms of resistance between the two drugs. This benefit has not yet translated to an improvement in rPFS and OS. Based on the results of this study in conjunction with previously published studies, use of abiraterone before enzalutamide should be considered over the alternate sequence.

PURPOSE: To evaluate outcomes of disease progression based on the sequence of abiraterone and enzalutamide in veterans diagnosed with metastatic castration-resistant prostate cancer (mCRPC).

BACKGROUND: Two of the current options for mCRPC treatment are the novel oral hormonal agents abiraterone and enzalutamide. After progression on one of these agents, one option is to switch to the other agent not previously used. Previously published retrospective studies and one prospective study have shown a difference in outcomes favoring abiraterone followed by enzalutamide, while others have shown no difference based on sequence. The optimal sequence of abiraterone and enzalutamide is still unclear.

METHODS: This was a retrospective chart review of patients who received abiraterone and enzalutamide in sequence for the treatment of mCRPC within our healthcare system from April 28, 2011 through October 31, 2019. Baseline demographic information such as age, race, Gleason score, and prior treatments were collected. The primary outcome was combined prostate-specific antigen progression-free survival (cPSA-PFS). Secondary outcomes included radiographic PFS (rPFS), overall survival (OS), adverse events causing treatment discontinuation, and medication adherence. Between-group survival differences were estimated by the Kaplan-Meier method and an unadjusted Cox regression model.

RESULTS: A total of 77 patients met criteria for study inclusion, with 51 in the abiraterone-to-enzalutamide group (ABI-ENZ) and 26 in the enzalutamide-to-abiraterone group (ENZ-ABI). For the primary outcome of cPSA-PFS, the median survival of the ABI-ENZ and ENZ-ABI groups was 17.3 months (95% CI, 10.3-24.3 months) and 10.2 months (95% CI, 8.5-11.8 months), respectively, which was significantly different (log-rank P=0.009) in favor of the ABI-ENZ sequence (HR 0.46; 95% CI, 0.26-0.83). Secondary outcomes of rPFS and OS were not significantly different between groups.

CONCLUSION: This study adds to the evidence supporting the sequence of abiraterone before enzalutamide for improving PSA-PFS. It is thought this might be related to differences in mechanisms of resistance between the two drugs. This benefit has not yet translated to an improvement in rPFS and OS. Based on the results of this study in conjunction with previously published studies, use of abiraterone before enzalutamide should be considered over the alternate sequence.

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Prostate-Specific Antigen Decline >50% After 4 Weeks of Treatment Is an Indicator of Better Progression Free and Overall Survival Both With Abiraterone and Enzalutamide in Metastatic Castrate Resistant Prostate Cancer

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BACKGROUND: Abiraterone (ABI) and Enzalutamide (ENZA) are the most common medications used for metastatic castrate resistant prostate cancer (mCRPC). Post treatment prostate specific antigen (PSA) changes correlate with prognosis (1). Early PSA decline defined as PSA decline by >50 % at 4 weeks after starting treatment compared to baseline has been demonstrated to corresponds with improved PSA progression-free survival (PSA PFS) and overall survival (OS) (2). Based on our literature review, this relation has not been elucidated previously in the Veteran population.

METHODS: A retrospective chart review was conducted in subjects with mCRPC who had received ABI and ENZA from 2011 to 2019 at VA Fresno. Subjects must have received at least 3 months of each drug. The primary outcomes were to document PSAPFS and OS between patients with >50% and <50% decline in PSA at 4 weeks after starting treatment with either ABI or ENZA.

RESULTS: 50 patients were identified who were treated with Abiraterone. 30 (60%) patients had a PSA decrease of 50% or greater in the first 4 weeks. A 50% or greater decrease in PSA at 4 weeks after starting was associated with a better PSA PFS (15 vs 5 months) and better median OS (20.5 vs 12 months). 20 patients were identified treated with Enzalutamide. 13(65%) of patients had a PSA decrease of 50% or greater in the first 4 weeks. A 50% or greater decrease in PSA at 4 weeks was associated with a better PSA PFS (14.5 vs 5 months) and better median OS (20 vs 12 months). 50% of patients in the whole group were diagnosed with metastatic disease at initial diagnosis while the rest were previously treated for localized prostate cancer before being diagnosed as metastatic disease. Most baseline characteristics including, baseline PSA, the modality of initial localized treatment, Gleason score, previous treatment with chemotherapy were similar between the two comparison cohorts (>50% and <50% decrease in PSA after starting treatment with ABI or ENZA).

CONCLUSIONS: Early decrease in PSA is an independent marker for the efficacy of antiandrogen treatment with enzalutamide and abiraterone in metastatic hormone- resistant prostate cancer in the veteran population.

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BACKGROUND: Abiraterone (ABI) and Enzalutamide (ENZA) are the most common medications used for metastatic castrate resistant prostate cancer (mCRPC). Post treatment prostate specific antigen (PSA) changes correlate with prognosis (1). Early PSA decline defined as PSA decline by >50 % at 4 weeks after starting treatment compared to baseline has been demonstrated to corresponds with improved PSA progression-free survival (PSA PFS) and overall survival (OS) (2). Based on our literature review, this relation has not been elucidated previously in the Veteran population.

METHODS: A retrospective chart review was conducted in subjects with mCRPC who had received ABI and ENZA from 2011 to 2019 at VA Fresno. Subjects must have received at least 3 months of each drug. The primary outcomes were to document PSAPFS and OS between patients with >50% and <50% decline in PSA at 4 weeks after starting treatment with either ABI or ENZA.

RESULTS: 50 patients were identified who were treated with Abiraterone. 30 (60%) patients had a PSA decrease of 50% or greater in the first 4 weeks. A 50% or greater decrease in PSA at 4 weeks after starting was associated with a better PSA PFS (15 vs 5 months) and better median OS (20.5 vs 12 months). 20 patients were identified treated with Enzalutamide. 13(65%) of patients had a PSA decrease of 50% or greater in the first 4 weeks. A 50% or greater decrease in PSA at 4 weeks was associated with a better PSA PFS (14.5 vs 5 months) and better median OS (20 vs 12 months). 50% of patients in the whole group were diagnosed with metastatic disease at initial diagnosis while the rest were previously treated for localized prostate cancer before being diagnosed as metastatic disease. Most baseline characteristics including, baseline PSA, the modality of initial localized treatment, Gleason score, previous treatment with chemotherapy were similar between the two comparison cohorts (>50% and <50% decrease in PSA after starting treatment with ABI or ENZA).

CONCLUSIONS: Early decrease in PSA is an independent marker for the efficacy of antiandrogen treatment with enzalutamide and abiraterone in metastatic hormone- resistant prostate cancer in the veteran population.

BACKGROUND: Abiraterone (ABI) and Enzalutamide (ENZA) are the most common medications used for metastatic castrate resistant prostate cancer (mCRPC). Post treatment prostate specific antigen (PSA) changes correlate with prognosis (1). Early PSA decline defined as PSA decline by >50 % at 4 weeks after starting treatment compared to baseline has been demonstrated to corresponds with improved PSA progression-free survival (PSA PFS) and overall survival (OS) (2). Based on our literature review, this relation has not been elucidated previously in the Veteran population.

METHODS: A retrospective chart review was conducted in subjects with mCRPC who had received ABI and ENZA from 2011 to 2019 at VA Fresno. Subjects must have received at least 3 months of each drug. The primary outcomes were to document PSAPFS and OS between patients with >50% and <50% decline in PSA at 4 weeks after starting treatment with either ABI or ENZA.

RESULTS: 50 patients were identified who were treated with Abiraterone. 30 (60%) patients had a PSA decrease of 50% or greater in the first 4 weeks. A 50% or greater decrease in PSA at 4 weeks after starting was associated with a better PSA PFS (15 vs 5 months) and better median OS (20.5 vs 12 months). 20 patients were identified treated with Enzalutamide. 13(65%) of patients had a PSA decrease of 50% or greater in the first 4 weeks. A 50% or greater decrease in PSA at 4 weeks was associated with a better PSA PFS (14.5 vs 5 months) and better median OS (20 vs 12 months). 50% of patients in the whole group were diagnosed with metastatic disease at initial diagnosis while the rest were previously treated for localized prostate cancer before being diagnosed as metastatic disease. Most baseline characteristics including, baseline PSA, the modality of initial localized treatment, Gleason score, previous treatment with chemotherapy were similar between the two comparison cohorts (>50% and <50% decrease in PSA after starting treatment with ABI or ENZA).

CONCLUSIONS: Early decrease in PSA is an independent marker for the efficacy of antiandrogen treatment with enzalutamide and abiraterone in metastatic hormone- resistant prostate cancer in the veteran population.

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Prostate Cancer in a Transgender Woman

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INTRODUCTION: As a neoplasm specific to male reproductive anatomy, prostate cancer represents a complex disease experience for transgender women. We present a patient who initiated her male-to-female (MTF) transition amidst a new prostate cancer diagnosis.

CASE REPORT: A 58-year-old male presented with urinary retention and a PSA of 21.53 ng/ml. Prostate biopsy showed a Gleason 4+5 adenocarcinoma with no evidence of metastasis on imaging. The patient underwent radical prostatectomy, which showed seminal vesicle invasion. After surgery, the PSA nadired to 2.5 ng/ml. Salvage radiation and androgen deprivation therapy (ADT) with leuprolide was initiated. ADT-induced physical feminization prompted the patient to begin discussing lifelong gender dysphoria in group therapy. After completing radiation therapy, she opted for bilateral orchiectomy. Shortly thereafter, she started an estradiol patch. Five months later, the PSA level began to rise. Estradiol-induced carcinogenesis due to tumor estrogen receptor (ER) expression versus natural tumor progression was considered, so she underwent a 6-week trial without estradiol. PSA levels continued increasing, and the tumor was found to be ER-negative. Furthermore, the patient suffered psychological and physical side effects from pausing hormonal therapy, so estradiol was restarted. Abiraterone and prednisone were initiated with PSA response (<0.01 ng/ml).

DISCUSSION: To date, there have been ten reported cases of prostate cancer in MTF transgender patients. Prostate cancer management in this population carries unique considerations, such as the possible carcinogenic effect of estrogen. Estradiol, a commonly used hormone in trans female patients, is a ligand for ER-alpha and ER-beta, both of which are implicated in oncogenesis and progression of prostate cancer. ER-alpha expression is associated with higher Gleason score, more advanced disease, and shorter survival. Orchiectomy as an alternative to long-term ADT should be discussed. These patients may also face significant psycho-social challenges such as exacerbation of gender dysphoria by prostate cancer, difficulty engaging with health care providers, and issues with changing gender status in electronic health record. Mental health support, sensitivity to transgender pronouns, and goals-of-care discussions are critical. As gender fluidity becomes more prevalent, physicians need to tailor biopsychosocial cancer care for transgender patients.

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Correspondence: Monica Li ([email protected])

INTRODUCTION: As a neoplasm specific to male reproductive anatomy, prostate cancer represents a complex disease experience for transgender women. We present a patient who initiated her male-to-female (MTF) transition amidst a new prostate cancer diagnosis.

CASE REPORT: A 58-year-old male presented with urinary retention and a PSA of 21.53 ng/ml. Prostate biopsy showed a Gleason 4+5 adenocarcinoma with no evidence of metastasis on imaging. The patient underwent radical prostatectomy, which showed seminal vesicle invasion. After surgery, the PSA nadired to 2.5 ng/ml. Salvage radiation and androgen deprivation therapy (ADT) with leuprolide was initiated. ADT-induced physical feminization prompted the patient to begin discussing lifelong gender dysphoria in group therapy. After completing radiation therapy, she opted for bilateral orchiectomy. Shortly thereafter, she started an estradiol patch. Five months later, the PSA level began to rise. Estradiol-induced carcinogenesis due to tumor estrogen receptor (ER) expression versus natural tumor progression was considered, so she underwent a 6-week trial without estradiol. PSA levels continued increasing, and the tumor was found to be ER-negative. Furthermore, the patient suffered psychological and physical side effects from pausing hormonal therapy, so estradiol was restarted. Abiraterone and prednisone were initiated with PSA response (<0.01 ng/ml).

DISCUSSION: To date, there have been ten reported cases of prostate cancer in MTF transgender patients. Prostate cancer management in this population carries unique considerations, such as the possible carcinogenic effect of estrogen. Estradiol, a commonly used hormone in trans female patients, is a ligand for ER-alpha and ER-beta, both of which are implicated in oncogenesis and progression of prostate cancer. ER-alpha expression is associated with higher Gleason score, more advanced disease, and shorter survival. Orchiectomy as an alternative to long-term ADT should be discussed. These patients may also face significant psycho-social challenges such as exacerbation of gender dysphoria by prostate cancer, difficulty engaging with health care providers, and issues with changing gender status in electronic health record. Mental health support, sensitivity to transgender pronouns, and goals-of-care discussions are critical. As gender fluidity becomes more prevalent, physicians need to tailor biopsychosocial cancer care for transgender patients.

INTRODUCTION: As a neoplasm specific to male reproductive anatomy, prostate cancer represents a complex disease experience for transgender women. We present a patient who initiated her male-to-female (MTF) transition amidst a new prostate cancer diagnosis.

CASE REPORT: A 58-year-old male presented with urinary retention and a PSA of 21.53 ng/ml. Prostate biopsy showed a Gleason 4+5 adenocarcinoma with no evidence of metastasis on imaging. The patient underwent radical prostatectomy, which showed seminal vesicle invasion. After surgery, the PSA nadired to 2.5 ng/ml. Salvage radiation and androgen deprivation therapy (ADT) with leuprolide was initiated. ADT-induced physical feminization prompted the patient to begin discussing lifelong gender dysphoria in group therapy. After completing radiation therapy, she opted for bilateral orchiectomy. Shortly thereafter, she started an estradiol patch. Five months later, the PSA level began to rise. Estradiol-induced carcinogenesis due to tumor estrogen receptor (ER) expression versus natural tumor progression was considered, so she underwent a 6-week trial without estradiol. PSA levels continued increasing, and the tumor was found to be ER-negative. Furthermore, the patient suffered psychological and physical side effects from pausing hormonal therapy, so estradiol was restarted. Abiraterone and prednisone were initiated with PSA response (<0.01 ng/ml).

DISCUSSION: To date, there have been ten reported cases of prostate cancer in MTF transgender patients. Prostate cancer management in this population carries unique considerations, such as the possible carcinogenic effect of estrogen. Estradiol, a commonly used hormone in trans female patients, is a ligand for ER-alpha and ER-beta, both of which are implicated in oncogenesis and progression of prostate cancer. ER-alpha expression is associated with higher Gleason score, more advanced disease, and shorter survival. Orchiectomy as an alternative to long-term ADT should be discussed. These patients may also face significant psycho-social challenges such as exacerbation of gender dysphoria by prostate cancer, difficulty engaging with health care providers, and issues with changing gender status in electronic health record. Mental health support, sensitivity to transgender pronouns, and goals-of-care discussions are critical. As gender fluidity becomes more prevalent, physicians need to tailor biopsychosocial cancer care for transgender patients.

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Evidence-Based Project and Quality Initiative Towards Improving Decision Making and Outcomes in Prostate Cancer Bone Health at Salt Lake City VA

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PURPOSE/BACKGROUND: Long term androgen deprivation therapy (ADT) forms the backbone of treatment of locally advanced and metastatic prostate cancer. Bone modifying agents, such as bisphosphonates and denosumab, may be indicated in osteoporosis dosing in the castration-sensitive setting, and more intense dosing for bone metastases in the castration-resistant setting only. Dental evaluation and care prior to bone modifying agent use in osteoporosis or bone metastases has safety benefit. Historical lack of clinical practice guidelines for bone health in men with prostate cancer have limited evidence-based practice. A retrospective review of patients on active bone remodeling therapies for prostate cancer, Revealed that several patients with castration-sensitive disease received treatment at dosing supported only in the setting of castration resistance with bone metastases. Some patients had not completed dental evaluation prior to initiation of bone modifying agents.

METHODS: Following evidence-based expert consensus recommendations from multiple sources regarding bone health in prostate cancer, we created an algorithm- based clinical practice tool. This decision tool is activated within the electronic medical record order set when starting therapy with a bone remodeling agent in patients with prostate cancer. The tool supports treatment with appropriate dosing for the indication, and ensures pretreatment supportive care, such as dental evaluation, is performed.

DATA ANALYSIS/RESULTS: Since implementation of the algorithm-based decision tool, 0/10 (0%) patients were placed on inappropriate bone modifying agent dosing and dental care was addressed on every patient 10/10 (100%) initiating treatment. When evaluating the effect of the decision tool on the desired outcomes, we note that the fraction of patients getting overly intensive treatment before and after implementation of the tool was 24/41 vs 0/10 (p = 0.0008); lack of pretreatment dental assessment before and after implementation of the tool was noted to be 12/41 vs 0/10): ( =0.09). Fisher’s Exact Test was used for both comparisons.

IMPLICATIONS: Through implementation of an evidence- based algorithm and clinical practice tool while prescribing bone remodeling agents to patients with prostate cancer, we were able to improve our institutional practice to a high quality evidenced-based approach to prostate cancer bone health care.

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PURPOSE/BACKGROUND: Long term androgen deprivation therapy (ADT) forms the backbone of treatment of locally advanced and metastatic prostate cancer. Bone modifying agents, such as bisphosphonates and denosumab, may be indicated in osteoporosis dosing in the castration-sensitive setting, and more intense dosing for bone metastases in the castration-resistant setting only. Dental evaluation and care prior to bone modifying agent use in osteoporosis or bone metastases has safety benefit. Historical lack of clinical practice guidelines for bone health in men with prostate cancer have limited evidence-based practice. A retrospective review of patients on active bone remodeling therapies for prostate cancer, Revealed that several patients with castration-sensitive disease received treatment at dosing supported only in the setting of castration resistance with bone metastases. Some patients had not completed dental evaluation prior to initiation of bone modifying agents.

METHODS: Following evidence-based expert consensus recommendations from multiple sources regarding bone health in prostate cancer, we created an algorithm- based clinical practice tool. This decision tool is activated within the electronic medical record order set when starting therapy with a bone remodeling agent in patients with prostate cancer. The tool supports treatment with appropriate dosing for the indication, and ensures pretreatment supportive care, such as dental evaluation, is performed.

DATA ANALYSIS/RESULTS: Since implementation of the algorithm-based decision tool, 0/10 (0%) patients were placed on inappropriate bone modifying agent dosing and dental care was addressed on every patient 10/10 (100%) initiating treatment. When evaluating the effect of the decision tool on the desired outcomes, we note that the fraction of patients getting overly intensive treatment before and after implementation of the tool was 24/41 vs 0/10 (p = 0.0008); lack of pretreatment dental assessment before and after implementation of the tool was noted to be 12/41 vs 0/10): ( =0.09). Fisher’s Exact Test was used for both comparisons.

IMPLICATIONS: Through implementation of an evidence- based algorithm and clinical practice tool while prescribing bone remodeling agents to patients with prostate cancer, we were able to improve our institutional practice to a high quality evidenced-based approach to prostate cancer bone health care.

PURPOSE/BACKGROUND: Long term androgen deprivation therapy (ADT) forms the backbone of treatment of locally advanced and metastatic prostate cancer. Bone modifying agents, such as bisphosphonates and denosumab, may be indicated in osteoporosis dosing in the castration-sensitive setting, and more intense dosing for bone metastases in the castration-resistant setting only. Dental evaluation and care prior to bone modifying agent use in osteoporosis or bone metastases has safety benefit. Historical lack of clinical practice guidelines for bone health in men with prostate cancer have limited evidence-based practice. A retrospective review of patients on active bone remodeling therapies for prostate cancer, Revealed that several patients with castration-sensitive disease received treatment at dosing supported only in the setting of castration resistance with bone metastases. Some patients had not completed dental evaluation prior to initiation of bone modifying agents.

METHODS: Following evidence-based expert consensus recommendations from multiple sources regarding bone health in prostate cancer, we created an algorithm- based clinical practice tool. This decision tool is activated within the electronic medical record order set when starting therapy with a bone remodeling agent in patients with prostate cancer. The tool supports treatment with appropriate dosing for the indication, and ensures pretreatment supportive care, such as dental evaluation, is performed.

DATA ANALYSIS/RESULTS: Since implementation of the algorithm-based decision tool, 0/10 (0%) patients were placed on inappropriate bone modifying agent dosing and dental care was addressed on every patient 10/10 (100%) initiating treatment. When evaluating the effect of the decision tool on the desired outcomes, we note that the fraction of patients getting overly intensive treatment before and after implementation of the tool was 24/41 vs 0/10 (p = 0.0008); lack of pretreatment dental assessment before and after implementation of the tool was noted to be 12/41 vs 0/10): ( =0.09). Fisher’s Exact Test was used for both comparisons.

IMPLICATIONS: Through implementation of an evidence- based algorithm and clinical practice tool while prescribing bone remodeling agents to patients with prostate cancer, we were able to improve our institutional practice to a high quality evidenced-based approach to prostate cancer bone health care.

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DNA Repair Gene Variants in Patients With Prostate Cancer Achieving Durable Clinical Benefit With PARP Inhibitors

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BACKGROUND: PARP inhibitors (PARPi’s) were recently approved for the treatment of metastatic prostate cancer among patients harboring mutations in an array of genes responsible for DNA repair. We sought to identify whether a subset of these genes correlates with response to treatment more frequently than others. Consequently, an evaluation of the specific DNA repair genotypes associated with durable clinical benefit (DCB) using real-world patient data was undertaken.

METHODS: The U.S. Department of Veterans Affairs (VA) National Precision Oncology Program’s (NPOP) database and Corporate Data Warehouse (CDW) were reviewed to select patients who (1) carried a diagnosis of prostate cancer, (2) successfully underwent tumor DNA sequencing through NPOP, (3) were prescribed olaparib, rucaparib, nirapib, and/or talazaporib for their prostate cancer between July 2016 and February 2020, and (4) and achieved DCB, defined as no progression in prostate-specific antigen (PSA) for at least 6 months following PARPi initiation without concurrent systemic or non-systemic therapies other than androgen-deprivation. The DNA repair gene variants and orders placed for NPOP consultative support were reviewed.

RESULTS: Of the 44 prostate cancer patients treated with a PARPi, 6 (13.6%) had tumor DNA sequencing through NPOP and had achieved DCB. Five patients were treated with olaparib and 1 with rucaparib. The median PSA progression-free survival was 8.9 (interquartile range = 8.5 – 11.2) months among these selected patients. Regarding gene variants, 5 patients had 7 BRCA2 mutations, including 4 frameshift, 1 nonsense, 1 single nucleotide variant, and 1 splice site. One patient had frameshift and missense ATM mutations. Referrals to the NPOP consult service were ordered for 2 out of the 5 patients with BRCA2 mutations achieving DCB.

CONCLUSIONS: Within the VA’s NPOP, the presence of BRCA2 gene variants was the most common finding from tumor DNA sequencing among patients with prostate cancer achieving DCB with a PARPi. Further analysis of the genotypes of all patients treated with PARPi in NPOP to assess the differential impact of BRCA2 mutations is needed to confirm the clinical implication of this finding.

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BACKGROUND: PARP inhibitors (PARPi’s) were recently approved for the treatment of metastatic prostate cancer among patients harboring mutations in an array of genes responsible for DNA repair. We sought to identify whether a subset of these genes correlates with response to treatment more frequently than others. Consequently, an evaluation of the specific DNA repair genotypes associated with durable clinical benefit (DCB) using real-world patient data was undertaken.

METHODS: The U.S. Department of Veterans Affairs (VA) National Precision Oncology Program’s (NPOP) database and Corporate Data Warehouse (CDW) were reviewed to select patients who (1) carried a diagnosis of prostate cancer, (2) successfully underwent tumor DNA sequencing through NPOP, (3) were prescribed olaparib, rucaparib, nirapib, and/or talazaporib for their prostate cancer between July 2016 and February 2020, and (4) and achieved DCB, defined as no progression in prostate-specific antigen (PSA) for at least 6 months following PARPi initiation without concurrent systemic or non-systemic therapies other than androgen-deprivation. The DNA repair gene variants and orders placed for NPOP consultative support were reviewed.

RESULTS: Of the 44 prostate cancer patients treated with a PARPi, 6 (13.6%) had tumor DNA sequencing through NPOP and had achieved DCB. Five patients were treated with olaparib and 1 with rucaparib. The median PSA progression-free survival was 8.9 (interquartile range = 8.5 – 11.2) months among these selected patients. Regarding gene variants, 5 patients had 7 BRCA2 mutations, including 4 frameshift, 1 nonsense, 1 single nucleotide variant, and 1 splice site. One patient had frameshift and missense ATM mutations. Referrals to the NPOP consult service were ordered for 2 out of the 5 patients with BRCA2 mutations achieving DCB.

CONCLUSIONS: Within the VA’s NPOP, the presence of BRCA2 gene variants was the most common finding from tumor DNA sequencing among patients with prostate cancer achieving DCB with a PARPi. Further analysis of the genotypes of all patients treated with PARPi in NPOP to assess the differential impact of BRCA2 mutations is needed to confirm the clinical implication of this finding.

BACKGROUND: PARP inhibitors (PARPi’s) were recently approved for the treatment of metastatic prostate cancer among patients harboring mutations in an array of genes responsible for DNA repair. We sought to identify whether a subset of these genes correlates with response to treatment more frequently than others. Consequently, an evaluation of the specific DNA repair genotypes associated with durable clinical benefit (DCB) using real-world patient data was undertaken.

METHODS: The U.S. Department of Veterans Affairs (VA) National Precision Oncology Program’s (NPOP) database and Corporate Data Warehouse (CDW) were reviewed to select patients who (1) carried a diagnosis of prostate cancer, (2) successfully underwent tumor DNA sequencing through NPOP, (3) were prescribed olaparib, rucaparib, nirapib, and/or talazaporib for their prostate cancer between July 2016 and February 2020, and (4) and achieved DCB, defined as no progression in prostate-specific antigen (PSA) for at least 6 months following PARPi initiation without concurrent systemic or non-systemic therapies other than androgen-deprivation. The DNA repair gene variants and orders placed for NPOP consultative support were reviewed.

RESULTS: Of the 44 prostate cancer patients treated with a PARPi, 6 (13.6%) had tumor DNA sequencing through NPOP and had achieved DCB. Five patients were treated with olaparib and 1 with rucaparib. The median PSA progression-free survival was 8.9 (interquartile range = 8.5 – 11.2) months among these selected patients. Regarding gene variants, 5 patients had 7 BRCA2 mutations, including 4 frameshift, 1 nonsense, 1 single nucleotide variant, and 1 splice site. One patient had frameshift and missense ATM mutations. Referrals to the NPOP consult service were ordered for 2 out of the 5 patients with BRCA2 mutations achieving DCB.

CONCLUSIONS: Within the VA’s NPOP, the presence of BRCA2 gene variants was the most common finding from tumor DNA sequencing among patients with prostate cancer achieving DCB with a PARPi. Further analysis of the genotypes of all patients treated with PARPi in NPOP to assess the differential impact of BRCA2 mutations is needed to confirm the clinical implication of this finding.

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Clinical and Dosimetric Predictors of Toxicity for Treatment of Localized Prostate Cancer Using Moderately Hypofractionated Radiotherapy

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PURPOSE: Moderately hypofractionated radiotherapy (MHRT) is a commonly used treatment modality for localized prostate cancer (LPC). In this setting, dosimetric correlations to acute and late toxicities remain poorly defined.

METHODS: Patients with LPC treated with MHRT between September 2008 and April 2018 were retrospectively identified. We excluded those with < 12 months follow up, elective nodal coverage, or additional boost. All patients received either 70Gy/28 fractions or 60Gy/20 fractions. Demographics, clinical outcomes, and toxicity data were obtained. Acute and late (≥3 months following MHRT completion) gastrointestinal (GI) and genitourinary (GU) toxicities were determined per CTCAE 5.0. Univariate and multivariate analyses were performed for acute and late grade 2+ GI/GU toxicity via logistic regression and log rank testing for demographic and dosimetric variables.

RESULTS: A total of 436 patients with LPC were treated with MHRT. Mean age was 64 years (IQR 60-68), median pre-treatment PSA was 8.7 (IQR 5.7-12.2), and T stages included T1a/2a (357), T2b/2c (58), and T3 (21). Acute grade 3 GU and GI toxicities were observed in 16(3.7%) and 3(0.7%) patients respectively, with no acute grade 4 toxicity events. Late grade 3 GU and GI toxicities were observed in 17(3.9%) and 4(0.9%) patients respectively, with two late grade 4 GI (0.05%) events. On multivariate analysis, acute grade 2+ GU toxicity was associated with pre-treatment PSA (odds ratio [OR] 1.02 95% confidence interval [CI] 1.01-1.04, P = 0.011) and pre-radiotherapy AUA SS (OR 1.06 95%CI: 1.03-1.09, P < 0.001); late grade 2+ GU toxicity was associated with pre-treatment AUA (hazard ratio [HR] 1.04 95%CI: 1.02-1.06, P < 0.001), lack of pre-treatment urinary meds (HR 0.65, 95%CI: 0.46-0.92, P = 0.049), and ADT use (HR 1.45, 95%CI: 1.03-2.03, P = 0.034); acute grade 2+ GI toxicity did demonstrate significant correlation; late grade 2+ GI toxicity was associated with ethnicity (Black vs White, HR 0.50, 95% CI: 0.25-0.99, P = 0.008) and pre-treatment PSA (HR 1.02, 95%CI: 1.00- 1.03, P = 0.024).

CONCLUSION: LPC patients completing MHRT experienced low rates of grade 3+ acute and late GU/GI toxicities. No dosimetric variables demonstrated significance on multivariate analysis of acute or late GU/ GI grade 2+ toxicity. Late grade 2+ GU toxicity was associated with ADT use, while late grade 2+ GI toxicity was associated with ethnicity and pre-treatment PSA.

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PURPOSE: Moderately hypofractionated radiotherapy (MHRT) is a commonly used treatment modality for localized prostate cancer (LPC). In this setting, dosimetric correlations to acute and late toxicities remain poorly defined.

METHODS: Patients with LPC treated with MHRT between September 2008 and April 2018 were retrospectively identified. We excluded those with < 12 months follow up, elective nodal coverage, or additional boost. All patients received either 70Gy/28 fractions or 60Gy/20 fractions. Demographics, clinical outcomes, and toxicity data were obtained. Acute and late (≥3 months following MHRT completion) gastrointestinal (GI) and genitourinary (GU) toxicities were determined per CTCAE 5.0. Univariate and multivariate analyses were performed for acute and late grade 2+ GI/GU toxicity via logistic regression and log rank testing for demographic and dosimetric variables.

RESULTS: A total of 436 patients with LPC were treated with MHRT. Mean age was 64 years (IQR 60-68), median pre-treatment PSA was 8.7 (IQR 5.7-12.2), and T stages included T1a/2a (357), T2b/2c (58), and T3 (21). Acute grade 3 GU and GI toxicities were observed in 16(3.7%) and 3(0.7%) patients respectively, with no acute grade 4 toxicity events. Late grade 3 GU and GI toxicities were observed in 17(3.9%) and 4(0.9%) patients respectively, with two late grade 4 GI (0.05%) events. On multivariate analysis, acute grade 2+ GU toxicity was associated with pre-treatment PSA (odds ratio [OR] 1.02 95% confidence interval [CI] 1.01-1.04, P = 0.011) and pre-radiotherapy AUA SS (OR 1.06 95%CI: 1.03-1.09, P < 0.001); late grade 2+ GU toxicity was associated with pre-treatment AUA (hazard ratio [HR] 1.04 95%CI: 1.02-1.06, P < 0.001), lack of pre-treatment urinary meds (HR 0.65, 95%CI: 0.46-0.92, P = 0.049), and ADT use (HR 1.45, 95%CI: 1.03-2.03, P = 0.034); acute grade 2+ GI toxicity did demonstrate significant correlation; late grade 2+ GI toxicity was associated with ethnicity (Black vs White, HR 0.50, 95% CI: 0.25-0.99, P = 0.008) and pre-treatment PSA (HR 1.02, 95%CI: 1.00- 1.03, P = 0.024).

CONCLUSION: LPC patients completing MHRT experienced low rates of grade 3+ acute and late GU/GI toxicities. No dosimetric variables demonstrated significance on multivariate analysis of acute or late GU/ GI grade 2+ toxicity. Late grade 2+ GU toxicity was associated with ADT use, while late grade 2+ GI toxicity was associated with ethnicity and pre-treatment PSA.

PURPOSE: Moderately hypofractionated radiotherapy (MHRT) is a commonly used treatment modality for localized prostate cancer (LPC). In this setting, dosimetric correlations to acute and late toxicities remain poorly defined.

METHODS: Patients with LPC treated with MHRT between September 2008 and April 2018 were retrospectively identified. We excluded those with < 12 months follow up, elective nodal coverage, or additional boost. All patients received either 70Gy/28 fractions or 60Gy/20 fractions. Demographics, clinical outcomes, and toxicity data were obtained. Acute and late (≥3 months following MHRT completion) gastrointestinal (GI) and genitourinary (GU) toxicities were determined per CTCAE 5.0. Univariate and multivariate analyses were performed for acute and late grade 2+ GI/GU toxicity via logistic regression and log rank testing for demographic and dosimetric variables.

RESULTS: A total of 436 patients with LPC were treated with MHRT. Mean age was 64 years (IQR 60-68), median pre-treatment PSA was 8.7 (IQR 5.7-12.2), and T stages included T1a/2a (357), T2b/2c (58), and T3 (21). Acute grade 3 GU and GI toxicities were observed in 16(3.7%) and 3(0.7%) patients respectively, with no acute grade 4 toxicity events. Late grade 3 GU and GI toxicities were observed in 17(3.9%) and 4(0.9%) patients respectively, with two late grade 4 GI (0.05%) events. On multivariate analysis, acute grade 2+ GU toxicity was associated with pre-treatment PSA (odds ratio [OR] 1.02 95% confidence interval [CI] 1.01-1.04, P = 0.011) and pre-radiotherapy AUA SS (OR 1.06 95%CI: 1.03-1.09, P < 0.001); late grade 2+ GU toxicity was associated with pre-treatment AUA (hazard ratio [HR] 1.04 95%CI: 1.02-1.06, P < 0.001), lack of pre-treatment urinary meds (HR 0.65, 95%CI: 0.46-0.92, P = 0.049), and ADT use (HR 1.45, 95%CI: 1.03-2.03, P = 0.034); acute grade 2+ GI toxicity did demonstrate significant correlation; late grade 2+ GI toxicity was associated with ethnicity (Black vs White, HR 0.50, 95% CI: 0.25-0.99, P = 0.008) and pre-treatment PSA (HR 1.02, 95%CI: 1.00- 1.03, P = 0.024).

CONCLUSION: LPC patients completing MHRT experienced low rates of grade 3+ acute and late GU/GI toxicities. No dosimetric variables demonstrated significance on multivariate analysis of acute or late GU/ GI grade 2+ toxicity. Late grade 2+ GU toxicity was associated with ADT use, while late grade 2+ GI toxicity was associated with ethnicity and pre-treatment PSA.

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A Cognitive-Behavioral Stress Management Group for Men with Urologic Cancers: Pre- and Post-COVID

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BACKGROUND: Urologic cancers and their treatments are associated with significant psychosocial challenges for veteran men, including sexual dysfunction, incontinence, fatigue, irritability, and depression. Although cancer support groups have been shown to be helpful for psychosocial distress, cognitive-behavioral stress management techniques have the capacity to directly address these challenges.

METHODS: A structured, open-enrollment, 6-session biweekly group was created in late 2017 as a cooperative effort between the urology department and comprehensive cancer center of a large VA medical center. Topics were selected based on their relevance to the population: (1) stress and the mind-body connection; (2) mindfulness; (3) sexual functioning and incontinence; (4) pain and sleep; (5) communicating with providers; and (6) managing anger and irritability. A clinical psychologist and/or psychology resident led the sessions, which include demonstration and practice of relaxation and mindfulness techniques, didactic presentations, and discussion. Medical providers received the group well and provides and a regular stream of referrals. Typical group size was between 2-6, and a total of 42 veterans have attended group sessions. The group was previously physically located in the urology clinic, reducing barriers and potentially stigma of access this type of service. After March 2020, the group transitioned to a weekly telephone- based group, continuing the same skills and topics, with good engagement and feedback from group members.

RESULTS: Group members have voiced increased confidence in managing their conditions and communicating with their providers, relief that they are not alone in their experience of potentially embarrassing side effects, and increased use of evidence-based stress management techniques.

CONCLUSION: Continuing this type of service during the COVID-19 pandemic has been important to help veteran manage the stress of postponed treatments (eg, radiation for prostate cancer), share information about hospital policies and procedures, and increase social connectedness with other similar patients.

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BACKGROUND: Urologic cancers and their treatments are associated with significant psychosocial challenges for veteran men, including sexual dysfunction, incontinence, fatigue, irritability, and depression. Although cancer support groups have been shown to be helpful for psychosocial distress, cognitive-behavioral stress management techniques have the capacity to directly address these challenges.

METHODS: A structured, open-enrollment, 6-session biweekly group was created in late 2017 as a cooperative effort between the urology department and comprehensive cancer center of a large VA medical center. Topics were selected based on their relevance to the population: (1) stress and the mind-body connection; (2) mindfulness; (3) sexual functioning and incontinence; (4) pain and sleep; (5) communicating with providers; and (6) managing anger and irritability. A clinical psychologist and/or psychology resident led the sessions, which include demonstration and practice of relaxation and mindfulness techniques, didactic presentations, and discussion. Medical providers received the group well and provides and a regular stream of referrals. Typical group size was between 2-6, and a total of 42 veterans have attended group sessions. The group was previously physically located in the urology clinic, reducing barriers and potentially stigma of access this type of service. After March 2020, the group transitioned to a weekly telephone- based group, continuing the same skills and topics, with good engagement and feedback from group members.

RESULTS: Group members have voiced increased confidence in managing their conditions and communicating with their providers, relief that they are not alone in their experience of potentially embarrassing side effects, and increased use of evidence-based stress management techniques.

CONCLUSION: Continuing this type of service during the COVID-19 pandemic has been important to help veteran manage the stress of postponed treatments (eg, radiation for prostate cancer), share information about hospital policies and procedures, and increase social connectedness with other similar patients.

BACKGROUND: Urologic cancers and their treatments are associated with significant psychosocial challenges for veteran men, including sexual dysfunction, incontinence, fatigue, irritability, and depression. Although cancer support groups have been shown to be helpful for psychosocial distress, cognitive-behavioral stress management techniques have the capacity to directly address these challenges.

METHODS: A structured, open-enrollment, 6-session biweekly group was created in late 2017 as a cooperative effort between the urology department and comprehensive cancer center of a large VA medical center. Topics were selected based on their relevance to the population: (1) stress and the mind-body connection; (2) mindfulness; (3) sexual functioning and incontinence; (4) pain and sleep; (5) communicating with providers; and (6) managing anger and irritability. A clinical psychologist and/or psychology resident led the sessions, which include demonstration and practice of relaxation and mindfulness techniques, didactic presentations, and discussion. Medical providers received the group well and provides and a regular stream of referrals. Typical group size was between 2-6, and a total of 42 veterans have attended group sessions. The group was previously physically located in the urology clinic, reducing barriers and potentially stigma of access this type of service. After March 2020, the group transitioned to a weekly telephone- based group, continuing the same skills and topics, with good engagement and feedback from group members.

RESULTS: Group members have voiced increased confidence in managing their conditions and communicating with their providers, relief that they are not alone in their experience of potentially embarrassing side effects, and increased use of evidence-based stress management techniques.

CONCLUSION: Continuing this type of service during the COVID-19 pandemic has been important to help veteran manage the stress of postponed treatments (eg, radiation for prostate cancer), share information about hospital policies and procedures, and increase social connectedness with other similar patients.

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Better continence rate gives robotic prostatectomy the edge

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Higher continence rates were seen after robot-assisted radical prostatectomy (RARP) than after laparoscopic radical prostatectomy (LRP) in the first large-scale, prospective, multicenter, randomized trial to compare the two surgical approaches.

At 3 months, 54.3% of prostate cancer patients who underwent RARP and 45.6% of those who had LRP were continent after catheter removal (P = .027).

“We did use a very strong definition for continence, meaning no pad or safety pad; patients wearing one pad per day we’re not classified as continent,” said study investigator Jens-Uwe Stolzenburg, MD, PhD, professor and head of urology at the University of Leipzig Hospital in Germany.

Dr. Stolzenburg presented these findings at the European Association of Urology virtual annual congress.

The findings fit with previous research showing higher continence rates with RARP (69%-80%) than with LRP (62%-63%), although those studies did not always find the difference to be statistically significant, and higher quality evidence was needed (J Sex Med. 2011 May;8[5]:1503-12; Eur Urol. 2013 Apr;63[4]:606-14). “Up to now, there are only two randomized studies published in the literature comparing robotic and classical laparoscopic prostatectomy, and my point of view is that there are strong limitations of both studies,” Dr. Stolzenburg said.

“First of all, both studies are based on the single experience of surgeons, so only one surgeon has performed surgery. The second limitation is the limited numbers of patients included,” he observed. One study had 64 patients in each arm, and the other had 60 patients in each arm.
 

Providing higher quality evidence

Dr. Stolzenburg presented results of the LAP-01 study, which was designed to close the knowledge gap and determine if there really was an advantage for RARP over LRP for preserving continence.

The trial was conducted at three academic centers and one public hospital in Germany. The final analysis included 718 patients with prostate cancer referred for prostate surgery. They were randomized, in a ratio of three to one, to undergo RARP (n = 530) or LRP (n = 188), being unaware themselves of which surgery they would be having until the 3-month primary endpoint.

In addition to improved continence over LRP, RARP was associated with significantly better erectile function at 3 months (P = .016), as measured by the International Index of Erectile Function (IIEF).

That said, erectile function was still severely affected by both surgical procedures. Total IIEF scores were 6.0 with RARP and 4.7 with LRP, compared with 15.9 and 16.2, respectively, at baseline.

A higher percentage of men who had nerve-sparing procedures reported having an erection suitable for sexual intercourse at 2 months in the RARP group than in the LRP group (17.7% vs. 6.7%, P = .007).

The complication rate was “a little bit higher” in the LRP group than in the RARP group, “but the difference was not statistically significant,” Dr. Stolzenburg said. He added that “the most frequent complication was anastomotic leakage, and most complications overall were low-grade complications in both groups.”
 

Multicenter experience

The potential for prostatectomy to have effects on urinary continence and sexual function are important issues that need to be discussed upfront with patients, observed Alexandre de la Taille, MD, PhD, who was invited to discuss the study.

Current European guidance says “there is no surgical approach – open, laparoscopic, or robotic radical prostatectomy – that has proven superiority in terms of functional or oncological results,” he said. However, the LAP-01 study “found that the continence rate was better when we use a robotic approach compared to a laparoscopic approach.”

Dr. de la Taille, who is professor and chair of the urology service at CHU Mondor in Cretéil, France, also highlighted that this result was achieved with no increase in the morbidity profile or compromise of cancer control.

“My very first impression is that we are missing a little bit, some granularity of the data in terms of one key question, which is volume of surgery,” said the chair of the session Alberto Briganti, MD, PhD, associate professor of urology at Università Vita-Salute San Raffaele, and deputy director of the Urological Research Institute of IRCCS Ospedale San Raffaele, both in Milan.

“We know that recovery of outcomes is volume-dependent, both in the laparoscopic and robotic setting,” Dr. Briganti added.

“This is really a multicenter study including a lot of surgeons,” Dr. de la Taille countered, agreeing that the volume of surgeries might be something the LAP-01 study investigators could look at in a sub-analysis.

“Of course, some of them have a huge experience in the robotic approach and some of them a lower experience of the robotic approach, but when you put all together, there is a better continence recovery at 3 months when compared to the laparoscopic approach,” Dr. de la Taille said.

Calling the study a “real-life practice study,” he noted that urinary continence at 12 months might be a stronger endpoint, and the difference between the two surgical approaches may become less with time.

“But for the patient, again, daily practice, it’s better to have early urinary continence recovery compared to a late recovery,” Dr. de la Taille said.

This study was funded by the University of Leipzig via a German Cancer Aid grant. All speakers declared no conflicts of interest.

SOURCE: Stolzenburg J-E. EAU20, Abstract.

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Higher continence rates were seen after robot-assisted radical prostatectomy (RARP) than after laparoscopic radical prostatectomy (LRP) in the first large-scale, prospective, multicenter, randomized trial to compare the two surgical approaches.

At 3 months, 54.3% of prostate cancer patients who underwent RARP and 45.6% of those who had LRP were continent after catheter removal (P = .027).

“We did use a very strong definition for continence, meaning no pad or safety pad; patients wearing one pad per day we’re not classified as continent,” said study investigator Jens-Uwe Stolzenburg, MD, PhD, professor and head of urology at the University of Leipzig Hospital in Germany.

Dr. Stolzenburg presented these findings at the European Association of Urology virtual annual congress.

The findings fit with previous research showing higher continence rates with RARP (69%-80%) than with LRP (62%-63%), although those studies did not always find the difference to be statistically significant, and higher quality evidence was needed (J Sex Med. 2011 May;8[5]:1503-12; Eur Urol. 2013 Apr;63[4]:606-14). “Up to now, there are only two randomized studies published in the literature comparing robotic and classical laparoscopic prostatectomy, and my point of view is that there are strong limitations of both studies,” Dr. Stolzenburg said.

“First of all, both studies are based on the single experience of surgeons, so only one surgeon has performed surgery. The second limitation is the limited numbers of patients included,” he observed. One study had 64 patients in each arm, and the other had 60 patients in each arm.
 

Providing higher quality evidence

Dr. Stolzenburg presented results of the LAP-01 study, which was designed to close the knowledge gap and determine if there really was an advantage for RARP over LRP for preserving continence.

The trial was conducted at three academic centers and one public hospital in Germany. The final analysis included 718 patients with prostate cancer referred for prostate surgery. They were randomized, in a ratio of three to one, to undergo RARP (n = 530) or LRP (n = 188), being unaware themselves of which surgery they would be having until the 3-month primary endpoint.

In addition to improved continence over LRP, RARP was associated with significantly better erectile function at 3 months (P = .016), as measured by the International Index of Erectile Function (IIEF).

That said, erectile function was still severely affected by both surgical procedures. Total IIEF scores were 6.0 with RARP and 4.7 with LRP, compared with 15.9 and 16.2, respectively, at baseline.

A higher percentage of men who had nerve-sparing procedures reported having an erection suitable for sexual intercourse at 2 months in the RARP group than in the LRP group (17.7% vs. 6.7%, P = .007).

The complication rate was “a little bit higher” in the LRP group than in the RARP group, “but the difference was not statistically significant,” Dr. Stolzenburg said. He added that “the most frequent complication was anastomotic leakage, and most complications overall were low-grade complications in both groups.”
 

Multicenter experience

The potential for prostatectomy to have effects on urinary continence and sexual function are important issues that need to be discussed upfront with patients, observed Alexandre de la Taille, MD, PhD, who was invited to discuss the study.

Current European guidance says “there is no surgical approach – open, laparoscopic, or robotic radical prostatectomy – that has proven superiority in terms of functional or oncological results,” he said. However, the LAP-01 study “found that the continence rate was better when we use a robotic approach compared to a laparoscopic approach.”

Dr. de la Taille, who is professor and chair of the urology service at CHU Mondor in Cretéil, France, also highlighted that this result was achieved with no increase in the morbidity profile or compromise of cancer control.

“My very first impression is that we are missing a little bit, some granularity of the data in terms of one key question, which is volume of surgery,” said the chair of the session Alberto Briganti, MD, PhD, associate professor of urology at Università Vita-Salute San Raffaele, and deputy director of the Urological Research Institute of IRCCS Ospedale San Raffaele, both in Milan.

“We know that recovery of outcomes is volume-dependent, both in the laparoscopic and robotic setting,” Dr. Briganti added.

“This is really a multicenter study including a lot of surgeons,” Dr. de la Taille countered, agreeing that the volume of surgeries might be something the LAP-01 study investigators could look at in a sub-analysis.

“Of course, some of them have a huge experience in the robotic approach and some of them a lower experience of the robotic approach, but when you put all together, there is a better continence recovery at 3 months when compared to the laparoscopic approach,” Dr. de la Taille said.

Calling the study a “real-life practice study,” he noted that urinary continence at 12 months might be a stronger endpoint, and the difference between the two surgical approaches may become less with time.

“But for the patient, again, daily practice, it’s better to have early urinary continence recovery compared to a late recovery,” Dr. de la Taille said.

This study was funded by the University of Leipzig via a German Cancer Aid grant. All speakers declared no conflicts of interest.

SOURCE: Stolzenburg J-E. EAU20, Abstract.

Higher continence rates were seen after robot-assisted radical prostatectomy (RARP) than after laparoscopic radical prostatectomy (LRP) in the first large-scale, prospective, multicenter, randomized trial to compare the two surgical approaches.

At 3 months, 54.3% of prostate cancer patients who underwent RARP and 45.6% of those who had LRP were continent after catheter removal (P = .027).

“We did use a very strong definition for continence, meaning no pad or safety pad; patients wearing one pad per day we’re not classified as continent,” said study investigator Jens-Uwe Stolzenburg, MD, PhD, professor and head of urology at the University of Leipzig Hospital in Germany.

Dr. Stolzenburg presented these findings at the European Association of Urology virtual annual congress.

The findings fit with previous research showing higher continence rates with RARP (69%-80%) than with LRP (62%-63%), although those studies did not always find the difference to be statistically significant, and higher quality evidence was needed (J Sex Med. 2011 May;8[5]:1503-12; Eur Urol. 2013 Apr;63[4]:606-14). “Up to now, there are only two randomized studies published in the literature comparing robotic and classical laparoscopic prostatectomy, and my point of view is that there are strong limitations of both studies,” Dr. Stolzenburg said.

“First of all, both studies are based on the single experience of surgeons, so only one surgeon has performed surgery. The second limitation is the limited numbers of patients included,” he observed. One study had 64 patients in each arm, and the other had 60 patients in each arm.
 

Providing higher quality evidence

Dr. Stolzenburg presented results of the LAP-01 study, which was designed to close the knowledge gap and determine if there really was an advantage for RARP over LRP for preserving continence.

The trial was conducted at three academic centers and one public hospital in Germany. The final analysis included 718 patients with prostate cancer referred for prostate surgery. They were randomized, in a ratio of three to one, to undergo RARP (n = 530) or LRP (n = 188), being unaware themselves of which surgery they would be having until the 3-month primary endpoint.

In addition to improved continence over LRP, RARP was associated with significantly better erectile function at 3 months (P = .016), as measured by the International Index of Erectile Function (IIEF).

That said, erectile function was still severely affected by both surgical procedures. Total IIEF scores were 6.0 with RARP and 4.7 with LRP, compared with 15.9 and 16.2, respectively, at baseline.

A higher percentage of men who had nerve-sparing procedures reported having an erection suitable for sexual intercourse at 2 months in the RARP group than in the LRP group (17.7% vs. 6.7%, P = .007).

The complication rate was “a little bit higher” in the LRP group than in the RARP group, “but the difference was not statistically significant,” Dr. Stolzenburg said. He added that “the most frequent complication was anastomotic leakage, and most complications overall were low-grade complications in both groups.”
 

Multicenter experience

The potential for prostatectomy to have effects on urinary continence and sexual function are important issues that need to be discussed upfront with patients, observed Alexandre de la Taille, MD, PhD, who was invited to discuss the study.

Current European guidance says “there is no surgical approach – open, laparoscopic, or robotic radical prostatectomy – that has proven superiority in terms of functional or oncological results,” he said. However, the LAP-01 study “found that the continence rate was better when we use a robotic approach compared to a laparoscopic approach.”

Dr. de la Taille, who is professor and chair of the urology service at CHU Mondor in Cretéil, France, also highlighted that this result was achieved with no increase in the morbidity profile or compromise of cancer control.

“My very first impression is that we are missing a little bit, some granularity of the data in terms of one key question, which is volume of surgery,” said the chair of the session Alberto Briganti, MD, PhD, associate professor of urology at Università Vita-Salute San Raffaele, and deputy director of the Urological Research Institute of IRCCS Ospedale San Raffaele, both in Milan.

“We know that recovery of outcomes is volume-dependent, both in the laparoscopic and robotic setting,” Dr. Briganti added.

“This is really a multicenter study including a lot of surgeons,” Dr. de la Taille countered, agreeing that the volume of surgeries might be something the LAP-01 study investigators could look at in a sub-analysis.

“Of course, some of them have a huge experience in the robotic approach and some of them a lower experience of the robotic approach, but when you put all together, there is a better continence recovery at 3 months when compared to the laparoscopic approach,” Dr. de la Taille said.

Calling the study a “real-life practice study,” he noted that urinary continence at 12 months might be a stronger endpoint, and the difference between the two surgical approaches may become less with time.

“But for the patient, again, daily practice, it’s better to have early urinary continence recovery compared to a late recovery,” Dr. de la Taille said.

This study was funded by the University of Leipzig via a German Cancer Aid grant. All speakers declared no conflicts of interest.

SOURCE: Stolzenburg J-E. EAU20, Abstract.

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