Prostate Cancer

Key clinical point: Niraparib is tolerable and shows activity in heavily pretreated patients with metastatic castration-resistant prostate cancer (mCRPC) and DNA repair gene defects (DRD).

Major finding: The median follow-up duration was 10 months and 8.6 months in the measurable BRCA and non-BRCA cohorts, respectively. The objective response rate was 34.2% in the measurable BRCA cohort and 10.6% in the measurable non-BRCA cohort. The most common grade 3 or higher adverse events were hematological (anemia, thrombocytopenia, and neutropenia). These adverse events were manageable with treatment interruptions, dose reductions, or supportive measures.

Study details: An open-label, single-arm, phase 2 GALAHAD study of 289 patients with histologically confirmed mCRPC and DRD who were treated with niraparib.

Disclosures: This study was sponsored by Janssen Research & Development. The authors received grants, contracts, payments, honoraria, travel support, and consulting/advisory/personal fees or reported being in a leadership role, holding stocks, or other ownership roles relative to Janssen Research & Development.

Source: Smith MR et al. Lancet Oncol. 2022 (Feb 4). Doi: 10.1016/S1470-2045(21)00757-9.

Key clinical point: Niraparib is tolerable and shows activity in heavily pretreated patients with metastatic castration-resistant prostate cancer (mCRPC) and DNA repair gene defects (DRD).

Major finding: The median follow-up duration was 10 months and 8.6 months in the measurable BRCA and non-BRCA cohorts, respectively. The objective response rate was 34.2% in the measurable BRCA cohort and 10.6% in the measurable non-BRCA cohort. The most common grade 3 or higher adverse events were hematological (anemia, thrombocytopenia, and neutropenia). These adverse events were manageable with treatment interruptions, dose reductions, or supportive measures.

Study details: An open-label, single-arm, phase 2 GALAHAD study of 289 patients with histologically confirmed mCRPC and DRD who were treated with niraparib.

Disclosures: This study was sponsored by Janssen Research & Development. The authors received grants, contracts, payments, honoraria, travel support, and consulting/advisory/personal fees or reported being in a leadership role, holding stocks, or other ownership roles relative to Janssen Research & Development.

Source: Smith MR et al. Lancet Oncol. 2022 (Feb 4). Doi: 10.1016/S1470-2045(21)00757-9.

Key clinical point: Niraparib is tolerable and shows activity in heavily pretreated patients with metastatic castration-resistant prostate cancer (mCRPC) and DNA repair gene defects (DRD).

Major finding: The median follow-up duration was 10 months and 8.6 months in the measurable BRCA and non-BRCA cohorts, respectively. The objective response rate was 34.2% in the measurable BRCA cohort and 10.6% in the measurable non-BRCA cohort. The most common grade 3 or higher adverse events were hematological (anemia, thrombocytopenia, and neutropenia). These adverse events were manageable with treatment interruptions, dose reductions, or supportive measures.

Study details: An open-label, single-arm, phase 2 GALAHAD study of 289 patients with histologically confirmed mCRPC and DRD who were treated with niraparib.

Disclosures: This study was sponsored by Janssen Research & Development. The authors received grants, contracts, payments, honoraria, travel support, and consulting/advisory/personal fees or reported being in a leadership role, holding stocks, or other ownership roles relative to Janssen Research & Development.

Source: Smith MR et al. Lancet Oncol. 2022 (Feb 4). Doi: 10.1016/S1470-2045(21)00757-9.

Key clinical point: The addition of dendritic cell vaccine immunotherapy for prostate cancer (DCVAC/PCa) to chemotherapy followed by DCVAC/PCa maintenance therapy does not extend overall survival in patients with metastatic castration-resistant prostate cancer (mCRPC).

Major finding: The overall survival was not significantly different between the DCVAC/PCa and placebo groups (median 23.9 months vs. 24.3 months; hazard ratio 1.04; P = .60). The treatment-emergent adverse event rate was 9.2% in the DCVAC/PCa group and 12.7% in the placebo group.

Study details: A double-blind, parallel-group, placebo-controlled, phase 3 randomized VIABLE study of 1,182 patients with mCRPC who were randomly assigned to receive DCVAC/PCa plus chemotherapy followed by DCVAC/PCa (n = 787) or placebo (n = 395).

Disclosures: This study was sponsored by Sotio a.s. The authors received research funding, grants, personal/advisory/consulting fees, and nonfinancial support or had stock ownership or patents.

Source: Vogelzang NJ et al. JAMA Oncol. 2022 (Feb 10). Doi: 10.1001/jamaoncol.2021.7298.

Key clinical point: The addition of dendritic cell vaccine immunotherapy for prostate cancer (DCVAC/PCa) to chemotherapy followed by DCVAC/PCa maintenance therapy does not extend overall survival in patients with metastatic castration-resistant prostate cancer (mCRPC).

Major finding: The overall survival was not significantly different between the DCVAC/PCa and placebo groups (median 23.9 months vs. 24.3 months; hazard ratio 1.04; P = .60). The treatment-emergent adverse event rate was 9.2% in the DCVAC/PCa group and 12.7% in the placebo group.

Study details: A double-blind, parallel-group, placebo-controlled, phase 3 randomized VIABLE study of 1,182 patients with mCRPC who were randomly assigned to receive DCVAC/PCa plus chemotherapy followed by DCVAC/PCa (n = 787) or placebo (n = 395).

Disclosures: This study was sponsored by Sotio a.s. The authors received research funding, grants, personal/advisory/consulting fees, and nonfinancial support or had stock ownership or patents.

Source: Vogelzang NJ et al. JAMA Oncol. 2022 (Feb 10). Doi: 10.1001/jamaoncol.2021.7298.

Key clinical point: The addition of dendritic cell vaccine immunotherapy for prostate cancer (DCVAC/PCa) to chemotherapy followed by DCVAC/PCa maintenance therapy does not extend overall survival in patients with metastatic castration-resistant prostate cancer (mCRPC).

Major finding: The overall survival was not significantly different between the DCVAC/PCa and placebo groups (median 23.9 months vs. 24.3 months; hazard ratio 1.04; P = .60). The treatment-emergent adverse event rate was 9.2% in the DCVAC/PCa group and 12.7% in the placebo group.

Study details: A double-blind, parallel-group, placebo-controlled, phase 3 randomized VIABLE study of 1,182 patients with mCRPC who were randomly assigned to receive DCVAC/PCa plus chemotherapy followed by DCVAC/PCa (n = 787) or placebo (n = 395).

Disclosures: This study was sponsored by Sotio a.s. The authors received research funding, grants, personal/advisory/consulting fees, and nonfinancial support or had stock ownership or patents.

Source: Vogelzang NJ et al. JAMA Oncol. 2022 (Feb 10). Doi: 10.1001/jamaoncol.2021.7298.

The STAMPEDE platform included a multiple arm and multiple stage protocol to evaluate abiraterone and enzalutamide in high risk non-metastatic and metastatic disease in separate trials. In the accompanying article by Attard et. al, a meta-analysis of two separate trials conducted as part of the STAMPEDE platform was undertaken. In the first trial, patients with high-risk localized prostate cancer were randomized to androgen deprivation therapy (ADT) with or without abiraterone. In the second trial, similar patients were randomized to ADT versus ADT plus abiraterone plus enzalutamide. The primary outcome of metastasis-free survival and secondary outcome of overall survival [OS] were significantly longer for the treatment arms over ADT; however, the addition of enzalutamide to abiraterone did not result in additional benefit. In appropriately selected patients with high risk localized prostate cancer, abiraterone is a reasonable option to consider in appropriately selected patients.

While bone is the most frequent site of metastasis in men with prostate cancer, visceral metastases (predominantly liver or lung) has been associated with worse outcomes. However, lower incidence of visceral metastases makes conduct of studies focused on visceral disease challenging. Baciarello et al conducted a post-hoc analysis of the LATITUDE study (where men with metastatic castrate-sensitive disease were treated with ADT plus abiraterone or ADT alone) in participants with visceral disease. Overall, patients with visceral metastases derived OS benefit (55.4 versus 33 months). Patients with lung metastases had similar OS to the entire cohort; however, those with liver metastases still derived benefit but had lower OS (36.8 versus 25.6 months). These post-hoc findings suggest that liver metastases present unique challenges compare to other metastatic disease sites, but further study is needed.

In the ENZAMET trial, enzalutamide plus ADT was compared to ADT alone in patients with metastatic castrate-sensitive disease, and enzalutamide treatment was associated with improved OS. In the report by Stockler et al, quality of life metrics as assessed by periodic evaluation utilizing standard questionnaires were reported. Patients who received enzalutamide reported more fatigue and lower cognitive and physical function than those receiving placebo. However, the overall quality of life did not decrease. These important quality of life findings, which are increasingly being reported in similar studies, support the overall net benefit of utilization of enzalutamide in patients with metastatic castrate-sensitive disease.

The STAMPEDE platform included a multiple arm and multiple stage protocol to evaluate abiraterone and enzalutamide in high risk non-metastatic and metastatic disease in separate trials. In the accompanying article by Attard et. al, a meta-analysis of two separate trials conducted as part of the STAMPEDE platform was undertaken. In the first trial, patients with high-risk localized prostate cancer were randomized to androgen deprivation therapy (ADT) with or without abiraterone. In the second trial, similar patients were randomized to ADT versus ADT plus abiraterone plus enzalutamide. The primary outcome of metastasis-free survival and secondary outcome of overall survival [OS] were significantly longer for the treatment arms over ADT; however, the addition of enzalutamide to abiraterone did not result in additional benefit. In appropriately selected patients with high risk localized prostate cancer, abiraterone is a reasonable option to consider in appropriately selected patients.

While bone is the most frequent site of metastasis in men with prostate cancer, visceral metastases (predominantly liver or lung) has been associated with worse outcomes. However, lower incidence of visceral metastases makes conduct of studies focused on visceral disease challenging. Baciarello et al conducted a post-hoc analysis of the LATITUDE study (where men with metastatic castrate-sensitive disease were treated with ADT plus abiraterone or ADT alone) in participants with visceral disease. Overall, patients with visceral metastases derived OS benefit (55.4 versus 33 months). Patients with lung metastases had similar OS to the entire cohort; however, those with liver metastases still derived benefit but had lower OS (36.8 versus 25.6 months). These post-hoc findings suggest that liver metastases present unique challenges compare to other metastatic disease sites, but further study is needed.

In the ENZAMET trial, enzalutamide plus ADT was compared to ADT alone in patients with metastatic castrate-sensitive disease, and enzalutamide treatment was associated with improved OS. In the report by Stockler et al, quality of life metrics as assessed by periodic evaluation utilizing standard questionnaires were reported. Patients who received enzalutamide reported more fatigue and lower cognitive and physical function than those receiving placebo. However, the overall quality of life did not decrease. These important quality of life findings, which are increasingly being reported in similar studies, support the overall net benefit of utilization of enzalutamide in patients with metastatic castrate-sensitive disease.

The STAMPEDE platform included a multiple arm and multiple stage protocol to evaluate abiraterone and enzalutamide in high risk non-metastatic and metastatic disease in separate trials. In the accompanying article by Attard et. al, a meta-analysis of two separate trials conducted as part of the STAMPEDE platform was undertaken. In the first trial, patients with high-risk localized prostate cancer were randomized to androgen deprivation therapy (ADT) with or without abiraterone. In the second trial, similar patients were randomized to ADT versus ADT plus abiraterone plus enzalutamide. The primary outcome of metastasis-free survival and secondary outcome of overall survival [OS] were significantly longer for the treatment arms over ADT; however, the addition of enzalutamide to abiraterone did not result in additional benefit. In appropriately selected patients with high risk localized prostate cancer, abiraterone is a reasonable option to consider in appropriately selected patients.

While bone is the most frequent site of metastasis in men with prostate cancer, visceral metastases (predominantly liver or lung) has been associated with worse outcomes. However, lower incidence of visceral metastases makes conduct of studies focused on visceral disease challenging. Baciarello et al conducted a post-hoc analysis of the LATITUDE study (where men with metastatic castrate-sensitive disease were treated with ADT plus abiraterone or ADT alone) in participants with visceral disease. Overall, patients with visceral metastases derived OS benefit (55.4 versus 33 months). Patients with lung metastases had similar OS to the entire cohort; however, those with liver metastases still derived benefit but had lower OS (36.8 versus 25.6 months). These post-hoc findings suggest that liver metastases present unique challenges compare to other metastatic disease sites, but further study is needed.

In the ENZAMET trial, enzalutamide plus ADT was compared to ADT alone in patients with metastatic castrate-sensitive disease, and enzalutamide treatment was associated with improved OS. In the report by Stockler et al, quality of life metrics as assessed by periodic evaluation utilizing standard questionnaires were reported. Patients who received enzalutamide reported more fatigue and lower cognitive and physical function than those receiving placebo. However, the overall quality of life did not decrease. These important quality of life findings, which are increasingly being reported in similar studies, support the overall net benefit of utilization of enzalutamide in patients with metastatic castrate-sensitive disease.

Key clinical point: Patients with prostate cancer who receive second-generation antiandrogens show higher risk for depression vs those who receive traditional hormone therapy (HT) alone or no HT.

Major finding: Second-generation antiandrogens were associated with increased risk for depression vs no HT (hazard ratio [HR], 2.15; P < .001). The risk for depression with second-generation antiandrogens was also higher vs traditional HT (HR, 2.26; P < .001), including specifically among those with metastatic disease at diagnosis (HR, 2.40; P = .002).

Study details: A retrospective study of 30,069 patients with prostate cancer without a second cancer over the course of 12 months between 2011 and 2015.

Disclosures: This work is supported by National Institutes of Health, Cancer Prevention and Research Institute of Texas, and Susan G. Komen for the Cure. The authors did not report any conflict of interests.

Source: Nowakowska MK et al. JAMA Netw Open. 2021 Dec 23. doi: 10.1001/jamanetworkopen.2021.40803.

Key clinical point: Patients with prostate cancer who receive second-generation antiandrogens show higher risk for depression vs those who receive traditional hormone therapy (HT) alone or no HT.

Major finding: Second-generation antiandrogens were associated with increased risk for depression vs no HT (hazard ratio [HR], 2.15; P < .001). The risk for depression with second-generation antiandrogens was also higher vs traditional HT (HR, 2.26; P < .001), including specifically among those with metastatic disease at diagnosis (HR, 2.40; P = .002).

Study details: A retrospective study of 30,069 patients with prostate cancer without a second cancer over the course of 12 months between 2011 and 2015.

Disclosures: This work is supported by National Institutes of Health, Cancer Prevention and Research Institute of Texas, and Susan G. Komen for the Cure. The authors did not report any conflict of interests.

Source: Nowakowska MK et al. JAMA Netw Open. 2021 Dec 23. doi: 10.1001/jamanetworkopen.2021.40803.

Key clinical point: Patients with prostate cancer who receive second-generation antiandrogens show higher risk for depression vs those who receive traditional hormone therapy (HT) alone or no HT.

Major finding: Second-generation antiandrogens were associated with increased risk for depression vs no HT (hazard ratio [HR], 2.15; P < .001). The risk for depression with second-generation antiandrogens was also higher vs traditional HT (HR, 2.26; P < .001), including specifically among those with metastatic disease at diagnosis (HR, 2.40; P = .002).

Study details: A retrospective study of 30,069 patients with prostate cancer without a second cancer over the course of 12 months between 2011 and 2015.

Disclosures: This work is supported by National Institutes of Health, Cancer Prevention and Research Institute of Texas, and Susan G. Komen for the Cure. The authors did not report any conflict of interests.

Source: Nowakowska MK et al. JAMA Netw Open. 2021 Dec 23. doi: 10.1001/jamanetworkopen.2021.40803.

Key clinical point: Men with a first- or second-degree family history of prostate cancer and a first-degree family history of breast cancer show increased risk for high-grade prostate cancer at biopsy.

Major finding: The risk for high-grade prostate cancer on biopsy increased in men with a first-degree family history (adjusted odds ratio [aOR], 1.77; P < .001) and a second-degree family history of the disease (aOR, 1.38; P = .011). A first-degree relative with breast cancer was associated with high-grade prostate cancer on biopsy (aOR, 1.30; P = .040).

Study details: A multicenter study of 15,799 men who underwent prostate biopsy between 2006 and 2019.

Disclosures: This work was supported by Research and Development Service, Urology Section, Surgery Department, and Department of Veterans Affairs, Caribbean Healthcare System San Juan, PR, USA. The authors disclosed being coinventor/employed, holding stocks, or received royalty.

Source: Clements MB et al. Eur Urol. 2021 Dec 31. doi: 10.1016/j.eururo.2021.12.011.

Key clinical point: Men with a first- or second-degree family history of prostate cancer and a first-degree family history of breast cancer show increased risk for high-grade prostate cancer at biopsy.

Major finding: The risk for high-grade prostate cancer on biopsy increased in men with a first-degree family history (adjusted odds ratio [aOR], 1.77; P < .001) and a second-degree family history of the disease (aOR, 1.38; P = .011). A first-degree relative with breast cancer was associated with high-grade prostate cancer on biopsy (aOR, 1.30; P = .040).

Study details: A multicenter study of 15,799 men who underwent prostate biopsy between 2006 and 2019.

Disclosures: This work was supported by Research and Development Service, Urology Section, Surgery Department, and Department of Veterans Affairs, Caribbean Healthcare System San Juan, PR, USA. The authors disclosed being coinventor/employed, holding stocks, or received royalty.

Source: Clements MB et al. Eur Urol. 2021 Dec 31. doi: 10.1016/j.eururo.2021.12.011.

Key clinical point: Men with a first- or second-degree family history of prostate cancer and a first-degree family history of breast cancer show increased risk for high-grade prostate cancer at biopsy.

Major finding: The risk for high-grade prostate cancer on biopsy increased in men with a first-degree family history (adjusted odds ratio [aOR], 1.77; P < .001) and a second-degree family history of the disease (aOR, 1.38; P = .011). A first-degree relative with breast cancer was associated with high-grade prostate cancer on biopsy (aOR, 1.30; P = .040).

Study details: A multicenter study of 15,799 men who underwent prostate biopsy between 2006 and 2019.

Disclosures: This work was supported by Research and Development Service, Urology Section, Surgery Department, and Department of Veterans Affairs, Caribbean Healthcare System San Juan, PR, USA. The authors disclosed being coinventor/employed, holding stocks, or received royalty.

Source: Clements MB et al. Eur Urol. 2021 Dec 31. doi: 10.1016/j.eururo.2021.12.011.

Key clinical point: A 3-tiered prostate cancer screening and risk stratification using a combination of prostate-specific antigen (PSA), 4-kallikrein panel, and magnetic resonance imaging (MRI) is feasible.

Major finding: The participation rate is 40%. PSA of 3 ng/mL or more was reported in 7% of men, 6% had a positive kallikrein panel, and 3% had suspicious MRI findings. Clinically significant cancer (Gleason score of ≥7) was detected in 5 men. The number needed to screen for clinically significant cancer was 32. Kallikrein panel and MRI after PSA reduced biopsy rate by 56%.

Study details: Study of 399 men invited for screening with 3 stepwise tests (PSA, kallikrein panel, and MRI).

Disclosures: This study was supported by Academy of Finland, Finnish Cancer Organisations, Jane and Aatos Erkko Foundation, and others. The authors received advisory/lecture fees, congress support, and royalties and held stocks outside this work.

Source: Rannikko A et al. BJU Int. 2021 Dec 27. doi: 10.1111/bju.15683.

Key clinical point: A 3-tiered prostate cancer screening and risk stratification using a combination of prostate-specific antigen (PSA), 4-kallikrein panel, and magnetic resonance imaging (MRI) is feasible.

Major finding: The participation rate is 40%. PSA of 3 ng/mL or more was reported in 7% of men, 6% had a positive kallikrein panel, and 3% had suspicious MRI findings. Clinically significant cancer (Gleason score of ≥7) was detected in 5 men. The number needed to screen for clinically significant cancer was 32. Kallikrein panel and MRI after PSA reduced biopsy rate by 56%.

Study details: Study of 399 men invited for screening with 3 stepwise tests (PSA, kallikrein panel, and MRI).

Disclosures: This study was supported by Academy of Finland, Finnish Cancer Organisations, Jane and Aatos Erkko Foundation, and others. The authors received advisory/lecture fees, congress support, and royalties and held stocks outside this work.

Source: Rannikko A et al. BJU Int. 2021 Dec 27. doi: 10.1111/bju.15683.

Key clinical point: A 3-tiered prostate cancer screening and risk stratification using a combination of prostate-specific antigen (PSA), 4-kallikrein panel, and magnetic resonance imaging (MRI) is feasible.

Major finding: The participation rate is 40%. PSA of 3 ng/mL or more was reported in 7% of men, 6% had a positive kallikrein panel, and 3% had suspicious MRI findings. Clinically significant cancer (Gleason score of ≥7) was detected in 5 men. The number needed to screen for clinically significant cancer was 32. Kallikrein panel and MRI after PSA reduced biopsy rate by 56%.

Study details: Study of 399 men invited for screening with 3 stepwise tests (PSA, kallikrein panel, and MRI).

Disclosures: This study was supported by Academy of Finland, Finnish Cancer Organisations, Jane and Aatos Erkko Foundation, and others. The authors received advisory/lecture fees, congress support, and royalties and held stocks outside this work.

Source: Rannikko A et al. BJU Int. 2021 Dec 27. doi: 10.1111/bju.15683.

Key clinical point: Docetaxel transiently decreased health-related quality of life (HRQoL) during chemotherapy in patients with intermediate-/high-risk localized prostate cancer, but the decline is temporary and recovers at 1 year. The decline was clinically meaningful in functional and physical domains.

Major finding: At the end of treatment (24 weeks), the HRQoL significantly declined in the docetaxel vs surveillance group (mean difference [MD], ─7.1 points; P < .0001). At 1 year, the HRQoL was similar between the 2 groups (P = .344). A clinically significant decline in HRQoL scores during treatment with docetaxel was reported in functional (MD, –2.43 points; P < .0001) and physical domains (MD, –2.89 points; P < .0001).

Study details: Post hoc analysis of a randomized, phase 3 SPCG-13 study including 376 patients with intermediate-/high-risk localized prostate cancer following radiotherapy were randomly assigned to docetaxel or surveillance.

Disclosures: This work was supported by Tampere University Hospital. The authors received advisory/speaker fees from various sources.

Source: Lehtonen M et al. Anticancer Res. 2021 Dec 29. doi: 10.21873/anticanres.15460.

Key clinical point: Docetaxel transiently decreased health-related quality of life (HRQoL) during chemotherapy in patients with intermediate-/high-risk localized prostate cancer, but the decline is temporary and recovers at 1 year. The decline was clinically meaningful in functional and physical domains.

Major finding: At the end of treatment (24 weeks), the HRQoL significantly declined in the docetaxel vs surveillance group (mean difference [MD], ─7.1 points; P < .0001). At 1 year, the HRQoL was similar between the 2 groups (P = .344). A clinically significant decline in HRQoL scores during treatment with docetaxel was reported in functional (MD, –2.43 points; P < .0001) and physical domains (MD, –2.89 points; P < .0001).

Study details: Post hoc analysis of a randomized, phase 3 SPCG-13 study including 376 patients with intermediate-/high-risk localized prostate cancer following radiotherapy were randomly assigned to docetaxel or surveillance.

Disclosures: This work was supported by Tampere University Hospital. The authors received advisory/speaker fees from various sources.

Source: Lehtonen M et al. Anticancer Res. 2021 Dec 29. doi: 10.21873/anticanres.15460.

Key clinical point: Docetaxel transiently decreased health-related quality of life (HRQoL) during chemotherapy in patients with intermediate-/high-risk localized prostate cancer, but the decline is temporary and recovers at 1 year. The decline was clinically meaningful in functional and physical domains.

Major finding: At the end of treatment (24 weeks), the HRQoL significantly declined in the docetaxel vs surveillance group (mean difference [MD], ─7.1 points; P < .0001). At 1 year, the HRQoL was similar between the 2 groups (P = .344). A clinically significant decline in HRQoL scores during treatment with docetaxel was reported in functional (MD, –2.43 points; P < .0001) and physical domains (MD, –2.89 points; P < .0001).

Study details: Post hoc analysis of a randomized, phase 3 SPCG-13 study including 376 patients with intermediate-/high-risk localized prostate cancer following radiotherapy were randomly assigned to docetaxel or surveillance.

Disclosures: This work was supported by Tampere University Hospital. The authors received advisory/speaker fees from various sources.

Source: Lehtonen M et al. Anticancer Res. 2021 Dec 29. doi: 10.21873/anticanres.15460.

Key clinical point: Apalutamide plus androgen deprivation therapy (ADT) leads to higher PSA responses by 6 months in patients with nonmetastatic castration-resistant prostate cancer (CRPC).

Major finding: At 6 months, a higher proportion of patients in the apalutamide vs placebo group reported a PSA reduction of ≥50% (90% vs 1.5%) and ≥90% (57% vs 0%). Deep PSA responses (PSA reduction of ≥50% or PSA levels of ≤0.2 ng/mL) at 6 months after apalutamide treatment were associated with a significant improvement in metastasis-free survival (P < .001) and overall survival (P < .001).

Study details: A post hoc analysis of phase 3 randomized SPARTAN trial of 1,207 patients with nonmetastatic CRPC randomly assigned to receive apalutamide (n=806) or placebo (n=401) plus ADT.

Disclosures: This study was sponsored by Janssen Research & Development. The authors reported employment, research funding, advisory/consulting roles, travel compensation, honoraria, stock ownership, royalties, or patents outside this work.

Source: Saad F et al. Eur Urol. 2021 Dec 13. doi: 10.1016/j.eururo.2021.11.020.

Key clinical point: Apalutamide plus androgen deprivation therapy (ADT) leads to higher PSA responses by 6 months in patients with nonmetastatic castration-resistant prostate cancer (CRPC).

Major finding: At 6 months, a higher proportion of patients in the apalutamide vs placebo group reported a PSA reduction of ≥50% (90% vs 1.5%) and ≥90% (57% vs 0%). Deep PSA responses (PSA reduction of ≥50% or PSA levels of ≤0.2 ng/mL) at 6 months after apalutamide treatment were associated with a significant improvement in metastasis-free survival (P < .001) and overall survival (P < .001).

Study details: A post hoc analysis of phase 3 randomized SPARTAN trial of 1,207 patients with nonmetastatic CRPC randomly assigned to receive apalutamide (n=806) or placebo (n=401) plus ADT.

Disclosures: This study was sponsored by Janssen Research & Development. The authors reported employment, research funding, advisory/consulting roles, travel compensation, honoraria, stock ownership, royalties, or patents outside this work.

Source: Saad F et al. Eur Urol. 2021 Dec 13. doi: 10.1016/j.eururo.2021.11.020.

Key clinical point: Apalutamide plus androgen deprivation therapy (ADT) leads to higher PSA responses by 6 months in patients with nonmetastatic castration-resistant prostate cancer (CRPC).

Major finding: At 6 months, a higher proportion of patients in the apalutamide vs placebo group reported a PSA reduction of ≥50% (90% vs 1.5%) and ≥90% (57% vs 0%). Deep PSA responses (PSA reduction of ≥50% or PSA levels of ≤0.2 ng/mL) at 6 months after apalutamide treatment were associated with a significant improvement in metastasis-free survival (P < .001) and overall survival (P < .001).

Study details: A post hoc analysis of phase 3 randomized SPARTAN trial of 1,207 patients with nonmetastatic CRPC randomly assigned to receive apalutamide (n=806) or placebo (n=401) plus ADT.

Disclosures: This study was sponsored by Janssen Research & Development. The authors reported employment, research funding, advisory/consulting roles, travel compensation, honoraria, stock ownership, royalties, or patents outside this work.

Source: Saad F et al. Eur Urol. 2021 Dec 13. doi: 10.1016/j.eururo.2021.11.020.

Key clinical point: Enzalutamide was associated with worsening of self-reported fatigue, cognitive function, and physical function, but not overall health and quality of life (OHQL) in newly diagnosed patients with metastatic hormone-sensitive prostate cancer (HSPC).

Major finding: Conventional nonsteroidal antiandrogen vs enzalutamide was associated with less worsening of fatigue (mean difference [MD], 5.2; P < .001), cognitive function (MD, 4.0; P < .001), and physical function (MD, 2.6; P < .001), but not OHQL (MD, 1.2; P = .1).

Study details: An open-label, international, randomized, phase 3, cooperative group ENZAMET trial of newly diagnosed patients with metastatic prostate cancer who were randomly assigned to enzalutamide or a conventional nonsteroidal antiandrogen.

Disclosures: This study was funded by Astellas. The authors received speakers/advisory/consulting fees, honoraria, research funding, royalties, and travel/accommodation expenses; were employed by; held stocks/other ownership interests; and had leadership roles outside this work.

Source: Stockler MR et al. J Clin Oncol. 2021 Dec 20. doi: 10.1200/JCO.21.00941.

Key clinical point: Enzalutamide was associated with worsening of self-reported fatigue, cognitive function, and physical function, but not overall health and quality of life (OHQL) in newly diagnosed patients with metastatic hormone-sensitive prostate cancer (HSPC).

Major finding: Conventional nonsteroidal antiandrogen vs enzalutamide was associated with less worsening of fatigue (mean difference [MD], 5.2; P < .001), cognitive function (MD, 4.0; P < .001), and physical function (MD, 2.6; P < .001), but not OHQL (MD, 1.2; P = .1).

Study details: An open-label, international, randomized, phase 3, cooperative group ENZAMET trial of newly diagnosed patients with metastatic prostate cancer who were randomly assigned to enzalutamide or a conventional nonsteroidal antiandrogen.

Disclosures: This study was funded by Astellas. The authors received speakers/advisory/consulting fees, honoraria, research funding, royalties, and travel/accommodation expenses; were employed by; held stocks/other ownership interests; and had leadership roles outside this work.

Source: Stockler MR et al. J Clin Oncol. 2021 Dec 20. doi: 10.1200/JCO.21.00941.

Key clinical point: Enzalutamide was associated with worsening of self-reported fatigue, cognitive function, and physical function, but not overall health and quality of life (OHQL) in newly diagnosed patients with metastatic hormone-sensitive prostate cancer (HSPC).

Major finding: Conventional nonsteroidal antiandrogen vs enzalutamide was associated with less worsening of fatigue (mean difference [MD], 5.2; P < .001), cognitive function (MD, 4.0; P < .001), and physical function (MD, 2.6; P < .001), but not OHQL (MD, 1.2; P = .1).

Study details: An open-label, international, randomized, phase 3, cooperative group ENZAMET trial of newly diagnosed patients with metastatic prostate cancer who were randomly assigned to enzalutamide or a conventional nonsteroidal antiandrogen.

Disclosures: This study was funded by Astellas. The authors received speakers/advisory/consulting fees, honoraria, research funding, royalties, and travel/accommodation expenses; were employed by; held stocks/other ownership interests; and had leadership roles outside this work.

Source: Stockler MR et al. J Clin Oncol. 2021 Dec 20. doi: 10.1200/JCO.21.00941.

Key clinical point: In patients with metastatic castration-resistant prostate cancer (mCRPC), enzalutamide improves outcomes independent of concurrent corticosteroid use (CCU).

Major finding: In patients with baseline CCU, enzalutamide vs placebo improved overall survival (OS; hazard ratio [HR], 0.70; P = .012), radiographic progression-free survival (rPFS; HR, 0.59; P < .001), and time to prostate-specific antigen progression (TTPP; HR, 0.36; P < .001). Enzalutamide improved OS (HR, 0.59; P < .001), rPFS (HR, 0.33; P < .001) and TTPP (HR, 0.22; P < .001) in patients with no CCU.

Study details: A post hoc analysis of phase 3, randomized AFFIRM trial of 1,199 patients with mCRPC who were randomly assigned to enzalutamide 160 mg/day or placebo.

Disclosures: This work was supported by Pfizer Inc. and Astellas Pharma, Inc. The authors received honoraria, advisory/consulting fees, nonfinancial support, and/or research funding outside this work. Some authors reported being employed, held patents, and/or were inventors or investigators.

Source: Zhao JL et al. Clin Cancer Res. 2021 Dec 29. doi: 10.1158/1078-0432.CCR-21-1090.

Key clinical point: In patients with metastatic castration-resistant prostate cancer (mCRPC), enzalutamide improves outcomes independent of concurrent corticosteroid use (CCU).

Major finding: In patients with baseline CCU, enzalutamide vs placebo improved overall survival (OS; hazard ratio [HR], 0.70; P = .012), radiographic progression-free survival (rPFS; HR, 0.59; P < .001), and time to prostate-specific antigen progression (TTPP; HR, 0.36; P < .001). Enzalutamide improved OS (HR, 0.59; P < .001), rPFS (HR, 0.33; P < .001) and TTPP (HR, 0.22; P < .001) in patients with no CCU.

Study details: A post hoc analysis of phase 3, randomized AFFIRM trial of 1,199 patients with mCRPC who were randomly assigned to enzalutamide 160 mg/day or placebo.

Disclosures: This work was supported by Pfizer Inc. and Astellas Pharma, Inc. The authors received honoraria, advisory/consulting fees, nonfinancial support, and/or research funding outside this work. Some authors reported being employed, held patents, and/or were inventors or investigators.

Source: Zhao JL et al. Clin Cancer Res. 2021 Dec 29. doi: 10.1158/1078-0432.CCR-21-1090.

Key clinical point: In patients with metastatic castration-resistant prostate cancer (mCRPC), enzalutamide improves outcomes independent of concurrent corticosteroid use (CCU).

Major finding: In patients with baseline CCU, enzalutamide vs placebo improved overall survival (OS; hazard ratio [HR], 0.70; P = .012), radiographic progression-free survival (rPFS; HR, 0.59; P < .001), and time to prostate-specific antigen progression (TTPP; HR, 0.36; P < .001). Enzalutamide improved OS (HR, 0.59; P < .001), rPFS (HR, 0.33; P < .001) and TTPP (HR, 0.22; P < .001) in patients with no CCU.

Study details: A post hoc analysis of phase 3, randomized AFFIRM trial of 1,199 patients with mCRPC who were randomly assigned to enzalutamide 160 mg/day or placebo.

Disclosures: This work was supported by Pfizer Inc. and Astellas Pharma, Inc. The authors received honoraria, advisory/consulting fees, nonfinancial support, and/or research funding outside this work. Some authors reported being employed, held patents, and/or were inventors or investigators.

Source: Zhao JL et al. Clin Cancer Res. 2021 Dec 29. doi: 10.1158/1078-0432.CCR-21-1090.