Prostate Cancer

Key clinical point: A single-fraction high-dose-rate (HDR) brachytherapy boost followed by ultra-hypofractionated stereotactic body radiation therapy (SBRT) to the prostate and/or pelvic lymph nodes shows a low rate of early toxicity in patients with higher-risk prostate cancer.

Major finding: The median follow-up was 24.1 months. No grade 3 or worse genitourinary or gastrointestinal toxicities were reported. Acute and late grade 2 gastrointestinal adverse events (AEs) were 0.99% each. Acute and late grade 2 genitourinary AEs were 5.9% and 9.9%, respectively. The median time to a grade 2 genitourinary toxicity was 6 months.

Study details: A retrospective study of 101 patients with high-risk prostate cancer who received HDR brachytherapy combined with ultra-hypofractionated radiotherapy.

Disclosures: This work was supported by the National Institutes of Health. The authors received research funding, consulting fees, and/or honoraria and/or served as editor-in-chief.

Source: Gorovets D et al. Brachytherapy. 2021 Sep 26. doi: 10.1016/j.brachy.2021.08.006.

Key clinical point: A single-fraction high-dose-rate (HDR) brachytherapy boost followed by ultra-hypofractionated stereotactic body radiation therapy (SBRT) to the prostate and/or pelvic lymph nodes shows a low rate of early toxicity in patients with higher-risk prostate cancer.

Major finding: The median follow-up was 24.1 months. No grade 3 or worse genitourinary or gastrointestinal toxicities were reported. Acute and late grade 2 gastrointestinal adverse events (AEs) were 0.99% each. Acute and late grade 2 genitourinary AEs were 5.9% and 9.9%, respectively. The median time to a grade 2 genitourinary toxicity was 6 months.

Study details: A retrospective study of 101 patients with high-risk prostate cancer who received HDR brachytherapy combined with ultra-hypofractionated radiotherapy.

Disclosures: This work was supported by the National Institutes of Health. The authors received research funding, consulting fees, and/or honoraria and/or served as editor-in-chief.

Source: Gorovets D et al. Brachytherapy. 2021 Sep 26. doi: 10.1016/j.brachy.2021.08.006.

Key clinical point: A single-fraction high-dose-rate (HDR) brachytherapy boost followed by ultra-hypofractionated stereotactic body radiation therapy (SBRT) to the prostate and/or pelvic lymph nodes shows a low rate of early toxicity in patients with higher-risk prostate cancer.

Major finding: The median follow-up was 24.1 months. No grade 3 or worse genitourinary or gastrointestinal toxicities were reported. Acute and late grade 2 gastrointestinal adverse events (AEs) were 0.99% each. Acute and late grade 2 genitourinary AEs were 5.9% and 9.9%, respectively. The median time to a grade 2 genitourinary toxicity was 6 months.

Study details: A retrospective study of 101 patients with high-risk prostate cancer who received HDR brachytherapy combined with ultra-hypofractionated radiotherapy.

Disclosures: This work was supported by the National Institutes of Health. The authors received research funding, consulting fees, and/or honoraria and/or served as editor-in-chief.

Source: Gorovets D et al. Brachytherapy. 2021 Sep 26. doi: 10.1016/j.brachy.2021.08.006.

Key clinical point: Use of chemotherapy and survival has increased in contemporary patients with de novo metastatic prostate cancer vs historical patients.

Major finding: The rates of chemotherapy were not significantly different between 2004 and 2013 (P = .3). The chemotherapy rates increased from 17.2% to 24.7% between 2014 and 2016 (P = .04). After propensity score matching, the median overall survival was significantly longer in contemporary vs. historical patients (not reached vs 25 months; adjusted hazard ratio [aHR], 0.55; P < .001). Cancer-specific mortality also improved in contemporary patients (not reached vs. 26 months; aHR, 0.55; P < .001).

Study details: A retrospective study of 19,913 patients who had de novo metastatic prostate cancer between 2004 and 2016, divided between historical (2004-2013) and contemporary (2014-2016).

Disclosures: No funding source was identified for this work. The authors had no competing interests.

Source: Hoeh B et al. Prostate. 2021 Sep 15. doi: 10.1002/pros.24235.

Key clinical point: Use of chemotherapy and survival has increased in contemporary patients with de novo metastatic prostate cancer vs historical patients.

Major finding: The rates of chemotherapy were not significantly different between 2004 and 2013 (P = .3). The chemotherapy rates increased from 17.2% to 24.7% between 2014 and 2016 (P = .04). After propensity score matching, the median overall survival was significantly longer in contemporary vs. historical patients (not reached vs 25 months; adjusted hazard ratio [aHR], 0.55; P < .001). Cancer-specific mortality also improved in contemporary patients (not reached vs. 26 months; aHR, 0.55; P < .001).

Study details: A retrospective study of 19,913 patients who had de novo metastatic prostate cancer between 2004 and 2016, divided between historical (2004-2013) and contemporary (2014-2016).

Disclosures: No funding source was identified for this work. The authors had no competing interests.

Source: Hoeh B et al. Prostate. 2021 Sep 15. doi: 10.1002/pros.24235.

Key clinical point: Use of chemotherapy and survival has increased in contemporary patients with de novo metastatic prostate cancer vs historical patients.

Major finding: The rates of chemotherapy were not significantly different between 2004 and 2013 (P = .3). The chemotherapy rates increased from 17.2% to 24.7% between 2014 and 2016 (P = .04). After propensity score matching, the median overall survival was significantly longer in contemporary vs. historical patients (not reached vs 25 months; adjusted hazard ratio [aHR], 0.55; P < .001). Cancer-specific mortality also improved in contemporary patients (not reached vs. 26 months; aHR, 0.55; P < .001).

Study details: A retrospective study of 19,913 patients who had de novo metastatic prostate cancer between 2004 and 2016, divided between historical (2004-2013) and contemporary (2014-2016).

Disclosures: No funding source was identified for this work. The authors had no competing interests.

Source: Hoeh B et al. Prostate. 2021 Sep 15. doi: 10.1002/pros.24235.

Key clinical point: Bone-modifying agents (BMAs) are overused in the real world in patients with metastatic castration-sensitive prostate cancer (mCSPC).

Major finding: Receipt of BMAs was reported in 23.6% of patients within 180 days of diagnosis. The proportion of patients receiving BMAs within 180 days increased from 17.3% during 2007-2009 to 28.1% during 2012-2015.

Study details: A retrospective study of 2,627 patients with stage IV prostate cancer from the Surveillance, Epidemiology, and End Results-Medicare database, diagnosed between 2007 and 2015. Patients receiving BMAs before the diagnosis or with a history of hypercalcemia, osteoporosis, osteopenia, or bone fracture were not included.

Disclosures: This study was supported by the National Cancer Institute at the National Institutes of Health. The authors received awards, personal/consulting/advisory fees, grants, nonfinancial support, and/or research funding from various sources. Some authors reported stock ownerships in various companies.

Source: Mitchell AP et al. J Natl Cancer Inst. 2021 Oct 1. doi: 10.1093/jnci/djab196.

Key clinical point: Bone-modifying agents (BMAs) are overused in the real world in patients with metastatic castration-sensitive prostate cancer (mCSPC).

Major finding: Receipt of BMAs was reported in 23.6% of patients within 180 days of diagnosis. The proportion of patients receiving BMAs within 180 days increased from 17.3% during 2007-2009 to 28.1% during 2012-2015.

Study details: A retrospective study of 2,627 patients with stage IV prostate cancer from the Surveillance, Epidemiology, and End Results-Medicare database, diagnosed between 2007 and 2015. Patients receiving BMAs before the diagnosis or with a history of hypercalcemia, osteoporosis, osteopenia, or bone fracture were not included.

Disclosures: This study was supported by the National Cancer Institute at the National Institutes of Health. The authors received awards, personal/consulting/advisory fees, grants, nonfinancial support, and/or research funding from various sources. Some authors reported stock ownerships in various companies.

Source: Mitchell AP et al. J Natl Cancer Inst. 2021 Oct 1. doi: 10.1093/jnci/djab196.

Key clinical point: Bone-modifying agents (BMAs) are overused in the real world in patients with metastatic castration-sensitive prostate cancer (mCSPC).

Major finding: Receipt of BMAs was reported in 23.6% of patients within 180 days of diagnosis. The proportion of patients receiving BMAs within 180 days increased from 17.3% during 2007-2009 to 28.1% during 2012-2015.

Study details: A retrospective study of 2,627 patients with stage IV prostate cancer from the Surveillance, Epidemiology, and End Results-Medicare database, diagnosed between 2007 and 2015. Patients receiving BMAs before the diagnosis or with a history of hypercalcemia, osteoporosis, osteopenia, or bone fracture were not included.

Disclosures: This study was supported by the National Cancer Institute at the National Institutes of Health. The authors received awards, personal/consulting/advisory fees, grants, nonfinancial support, and/or research funding from various sources. Some authors reported stock ownerships in various companies.

Source: Mitchell AP et al. J Natl Cancer Inst. 2021 Oct 1. doi: 10.1093/jnci/djab196.

Key clinical point: Androgen-signaling inhibitors (ASIs) are associated with significant survival benefits in patients with metastatic castration-resistant prostate cancer (mCRPC) with luminal tumor subtype.

Major finding: ASI treatment was associated with an improved overall survival in patients with luminal tumors (hazard ratio [HR], 0.27; P < .001), but not in those with basal tumors (HR, 0.62; P = .07).

Study details: A retrospective study of 4 patient cohorts (n=634) with mCRPC.

Disclosures: This study was funded by grants from the Department of Defense, Stand Up To Cancer-Prostate Cancer Foundation, Prostate Cancer Foundation, Movember Foundation, UCSF Benioff, Swedish Research Council, National Cancer Institute, and University of Wisconsin Carbone Cancer Center. The authors received consulting/advisory fees, research funding, and grants outside this work. Some authors reported pending patents and/or being employed with pharmaceutical companies.

Source: Aggarwal R et al. JAMA Oncol. 2021 Sep 23. doi: 10.1001/jamaoncol.2021.3987.

Key clinical point: Androgen-signaling inhibitors (ASIs) are associated with significant survival benefits in patients with metastatic castration-resistant prostate cancer (mCRPC) with luminal tumor subtype.

Major finding: ASI treatment was associated with an improved overall survival in patients with luminal tumors (hazard ratio [HR], 0.27; P < .001), but not in those with basal tumors (HR, 0.62; P = .07).

Study details: A retrospective study of 4 patient cohorts (n=634) with mCRPC.

Disclosures: This study was funded by grants from the Department of Defense, Stand Up To Cancer-Prostate Cancer Foundation, Prostate Cancer Foundation, Movember Foundation, UCSF Benioff, Swedish Research Council, National Cancer Institute, and University of Wisconsin Carbone Cancer Center. The authors received consulting/advisory fees, research funding, and grants outside this work. Some authors reported pending patents and/or being employed with pharmaceutical companies.

Source: Aggarwal R et al. JAMA Oncol. 2021 Sep 23. doi: 10.1001/jamaoncol.2021.3987.

Key clinical point: Androgen-signaling inhibitors (ASIs) are associated with significant survival benefits in patients with metastatic castration-resistant prostate cancer (mCRPC) with luminal tumor subtype.

Major finding: ASI treatment was associated with an improved overall survival in patients with luminal tumors (hazard ratio [HR], 0.27; P < .001), but not in those with basal tumors (HR, 0.62; P = .07).

Study details: A retrospective study of 4 patient cohorts (n=634) with mCRPC.

Disclosures: This study was funded by grants from the Department of Defense, Stand Up To Cancer-Prostate Cancer Foundation, Prostate Cancer Foundation, Movember Foundation, UCSF Benioff, Swedish Research Council, National Cancer Institute, and University of Wisconsin Carbone Cancer Center. The authors received consulting/advisory fees, research funding, and grants outside this work. Some authors reported pending patents and/or being employed with pharmaceutical companies.

Source: Aggarwal R et al. JAMA Oncol. 2021 Sep 23. doi: 10.1001/jamaoncol.2021.3987.

Key clinical point: External beam radiation therapy (EBRT) does not show a survival benefit in newly diagnosed elderly patients with metastatic prostate cancer.

Major finding: Patients who received EBRT vs. those who did not showed similar overall survival (hazard ratio [HR], 0.97; P = .6) and cancer-specific survival (HR, 1.04; P = .4).

Study details: A retrospective study of 6,556 patients, aged 75 years and above, with metastatic prostate cancer identified from the Surveillance, Epidemiology and End Results database between 2004 and 2016, of which 1,105 received EBRT.

Disclosures: No study source was identified for this work. The authors declared no conflict of interests.

Source: Wenzel M et al. Prostate. 2021 Oct 11. doi: 10.1002/pros.24249.

Key clinical point: External beam radiation therapy (EBRT) does not show a survival benefit in newly diagnosed elderly patients with metastatic prostate cancer.

Major finding: Patients who received EBRT vs. those who did not showed similar overall survival (hazard ratio [HR], 0.97; P = .6) and cancer-specific survival (HR, 1.04; P = .4).

Study details: A retrospective study of 6,556 patients, aged 75 years and above, with metastatic prostate cancer identified from the Surveillance, Epidemiology and End Results database between 2004 and 2016, of which 1,105 received EBRT.

Disclosures: No study source was identified for this work. The authors declared no conflict of interests.

Source: Wenzel M et al. Prostate. 2021 Oct 11. doi: 10.1002/pros.24249.

Key clinical point: External beam radiation therapy (EBRT) does not show a survival benefit in newly diagnosed elderly patients with metastatic prostate cancer.

Major finding: Patients who received EBRT vs. those who did not showed similar overall survival (hazard ratio [HR], 0.97; P = .6) and cancer-specific survival (HR, 1.04; P = .4).

Study details: A retrospective study of 6,556 patients, aged 75 years and above, with metastatic prostate cancer identified from the Surveillance, Epidemiology and End Results database between 2004 and 2016, of which 1,105 received EBRT.

Disclosures: No study source was identified for this work. The authors declared no conflict of interests.

Source: Wenzel M et al. Prostate. 2021 Oct 11. doi: 10.1002/pros.24249.

Key clinical point: In patients with localized prostate cancer, robot-assisted laparoscopic prostatectomy (RALP) vs open retropubic radical prostatectomy (RRP) has similar prostate cancer-specific mortality (PCSM) and lower risk for erectile dysfunction in the long term.

Major finding: At 8 years, urinary incontinence was not significantly different between RALP and RRP groups. Erectile dysfunction was significantly lower in the RALP group (66% vs 70%; adjusted risk ratio, 0.93; 95% confidence interval [CI], 0.87-0.99). PCSM was significantly lower in the RALP group (adjusted hazard ratio, 0.56; 95% CI, 0.34-0.93).

Study details: A prospective, controlled, nonrandomized trial of 4,003 patients with localized prostate cancer who were randomly assigned to either RALP and RRP between 2008 and 2011.

Disclosures: This work was supported by the Swedish Cancer Society, Swedish Research Council, Region Västra Götaland, Sahlgrenska University Hospital, Mrs. Mary von Sydow Foundation, Anna and Edwin Berger Foundation, Stockholm County Council, and Swedish Medical Association. The authors declared no competing interests.

Source: Lantz A et al. Eur Urol. 2021 Sep 15. doi: 10.1016/j.eururo.2021.07.025.

Key clinical point: In patients with localized prostate cancer, robot-assisted laparoscopic prostatectomy (RALP) vs open retropubic radical prostatectomy (RRP) has similar prostate cancer-specific mortality (PCSM) and lower risk for erectile dysfunction in the long term.

Major finding: At 8 years, urinary incontinence was not significantly different between RALP and RRP groups. Erectile dysfunction was significantly lower in the RALP group (66% vs 70%; adjusted risk ratio, 0.93; 95% confidence interval [CI], 0.87-0.99). PCSM was significantly lower in the RALP group (adjusted hazard ratio, 0.56; 95% CI, 0.34-0.93).

Study details: A prospective, controlled, nonrandomized trial of 4,003 patients with localized prostate cancer who were randomly assigned to either RALP and RRP between 2008 and 2011.

Disclosures: This work was supported by the Swedish Cancer Society, Swedish Research Council, Region Västra Götaland, Sahlgrenska University Hospital, Mrs. Mary von Sydow Foundation, Anna and Edwin Berger Foundation, Stockholm County Council, and Swedish Medical Association. The authors declared no competing interests.

Source: Lantz A et al. Eur Urol. 2021 Sep 15. doi: 10.1016/j.eururo.2021.07.025.

Key clinical point: In patients with localized prostate cancer, robot-assisted laparoscopic prostatectomy (RALP) vs open retropubic radical prostatectomy (RRP) has similar prostate cancer-specific mortality (PCSM) and lower risk for erectile dysfunction in the long term.

Major finding: At 8 years, urinary incontinence was not significantly different between RALP and RRP groups. Erectile dysfunction was significantly lower in the RALP group (66% vs 70%; adjusted risk ratio, 0.93; 95% confidence interval [CI], 0.87-0.99). PCSM was significantly lower in the RALP group (adjusted hazard ratio, 0.56; 95% CI, 0.34-0.93).

Study details: A prospective, controlled, nonrandomized trial of 4,003 patients with localized prostate cancer who were randomly assigned to either RALP and RRP between 2008 and 2011.

Disclosures: This work was supported by the Swedish Cancer Society, Swedish Research Council, Region Västra Götaland, Sahlgrenska University Hospital, Mrs. Mary von Sydow Foundation, Anna and Edwin Berger Foundation, Stockholm County Council, and Swedish Medical Association. The authors declared no competing interests.

Source: Lantz A et al. Eur Urol. 2021 Sep 15. doi: 10.1016/j.eururo.2021.07.025.

Key clinical point: Adding abiraterone plus prednisone to androgen deprivation therapy (ADT) following definitive treatment in patients with biochemically recurrent castration-naïve prostate cancer prolongs prostate-specific antigen (PSA)-free survival (PSA less than 0.2 ng/mL).

Major finding: Abiraterone and prednisone plus ADT vs ADT alone significantly improved PSA-free survival (27.0 months vs 19.9 months; hazard ratio, 0.64; 95% confidence interval, 0.47-0.87).

Study details: A phase 2, randomized, open-label trial of 200 patients with nonmetastatic biochemically recurrent castration-naïve prostate cancer who were randomly assigned to either abiraterone plus prednisone to ADT or ADT alone following definitive treatment.

Disclosures: This study was funded by the Prostate Cancer Foundation, Janssen Research, Koch Center for Applied Biology, and Alexander & Eckstein Labs. The authors received research grant/funding, honoraria, advisory/consulting fees, and travel expenses. Dr. Subudhi SK declared ownership interest with Apricity Health.

Source: Spetsieri N et al. Eur J Cancer. 2021 Sep 15. doi: 10.1016/j.ejca.2021.06.017.

Key clinical point: Adding abiraterone plus prednisone to androgen deprivation therapy (ADT) following definitive treatment in patients with biochemically recurrent castration-naïve prostate cancer prolongs prostate-specific antigen (PSA)-free survival (PSA less than 0.2 ng/mL).

Major finding: Abiraterone and prednisone plus ADT vs ADT alone significantly improved PSA-free survival (27.0 months vs 19.9 months; hazard ratio, 0.64; 95% confidence interval, 0.47-0.87).

Study details: A phase 2, randomized, open-label trial of 200 patients with nonmetastatic biochemically recurrent castration-naïve prostate cancer who were randomly assigned to either abiraterone plus prednisone to ADT or ADT alone following definitive treatment.

Disclosures: This study was funded by the Prostate Cancer Foundation, Janssen Research, Koch Center for Applied Biology, and Alexander & Eckstein Labs. The authors received research grant/funding, honoraria, advisory/consulting fees, and travel expenses. Dr. Subudhi SK declared ownership interest with Apricity Health.

Source: Spetsieri N et al. Eur J Cancer. 2021 Sep 15. doi: 10.1016/j.ejca.2021.06.017.

Key clinical point: Adding abiraterone plus prednisone to androgen deprivation therapy (ADT) following definitive treatment in patients with biochemically recurrent castration-naïve prostate cancer prolongs prostate-specific antigen (PSA)-free survival (PSA less than 0.2 ng/mL).

Major finding: Abiraterone and prednisone plus ADT vs ADT alone significantly improved PSA-free survival (27.0 months vs 19.9 months; hazard ratio, 0.64; 95% confidence interval, 0.47-0.87).

Study details: A phase 2, randomized, open-label trial of 200 patients with nonmetastatic biochemically recurrent castration-naïve prostate cancer who were randomly assigned to either abiraterone plus prednisone to ADT or ADT alone following definitive treatment.

Disclosures: This study was funded by the Prostate Cancer Foundation, Janssen Research, Koch Center for Applied Biology, and Alexander & Eckstein Labs. The authors received research grant/funding, honoraria, advisory/consulting fees, and travel expenses. Dr. Subudhi SK declared ownership interest with Apricity Health.

Source: Spetsieri N et al. Eur J Cancer. 2021 Sep 15. doi: 10.1016/j.ejca.2021.06.017.

Key clinical point: Addition of apalutamide to abiraterone and prednisone improves radiographic progression-free survival (rPFS) in chemotherapy-naïve patients with metastatic castration-resistant prostate cancer (mCRPC).

Major finding: At a median follow-up of 54.8 months, apalutamide in combination with abiraterone plus prednisone vs. abiraterone plus prednisone significantly improves rPFS (24.0 months vs 16.6 months; hazard ratio, 0.70; P < .0001).

Study details: A randomized, placebo-controlled, double-blind, phase 3 ACIS study of 982 chemotherapy-naïve patients with mCRPC who were randomly assigned to either apalutamide plus abiraterone and prednisone or abiraterone plus prednisone.

Disclosures: The study received funding from Janssen Research & Development. The authors reported leadership roles and receiving financial support, grants/contracts, consulting fees, and payment or honoraria for lectures, presentations, speakers’ bureaus, manuscript writing, and/or educational events from various sources, and/or being employed with and holding stocks in pharmaceutical companies.

Source: Saad F et al. Lancet Oncol. 2021 Sep 30. doi: 10.1016/ S1470-2045(21)00402-2.

Key clinical point: Addition of apalutamide to abiraterone and prednisone improves radiographic progression-free survival (rPFS) in chemotherapy-naïve patients with metastatic castration-resistant prostate cancer (mCRPC).

Major finding: At a median follow-up of 54.8 months, apalutamide in combination with abiraterone plus prednisone vs. abiraterone plus prednisone significantly improves rPFS (24.0 months vs 16.6 months; hazard ratio, 0.70; P < .0001).

Study details: A randomized, placebo-controlled, double-blind, phase 3 ACIS study of 982 chemotherapy-naïve patients with mCRPC who were randomly assigned to either apalutamide plus abiraterone and prednisone or abiraterone plus prednisone.

Disclosures: The study received funding from Janssen Research & Development. The authors reported leadership roles and receiving financial support, grants/contracts, consulting fees, and payment or honoraria for lectures, presentations, speakers’ bureaus, manuscript writing, and/or educational events from various sources, and/or being employed with and holding stocks in pharmaceutical companies.

Source: Saad F et al. Lancet Oncol. 2021 Sep 30. doi: 10.1016/ S1470-2045(21)00402-2.

Key clinical point: Addition of apalutamide to abiraterone and prednisone improves radiographic progression-free survival (rPFS) in chemotherapy-naïve patients with metastatic castration-resistant prostate cancer (mCRPC).

Major finding: At a median follow-up of 54.8 months, apalutamide in combination with abiraterone plus prednisone vs. abiraterone plus prednisone significantly improves rPFS (24.0 months vs 16.6 months; hazard ratio, 0.70; P < .0001).

Study details: A randomized, placebo-controlled, double-blind, phase 3 ACIS study of 982 chemotherapy-naïve patients with mCRPC who were randomly assigned to either apalutamide plus abiraterone and prednisone or abiraterone plus prednisone.

Disclosures: The study received funding from Janssen Research & Development. The authors reported leadership roles and receiving financial support, grants/contracts, consulting fees, and payment or honoraria for lectures, presentations, speakers’ bureaus, manuscript writing, and/or educational events from various sources, and/or being employed with and holding stocks in pharmaceutical companies.

Source: Saad F et al. Lancet Oncol. 2021 Sep 30. doi: 10.1016/ S1470-2045(21)00402-2.

Key clinical point: In patients with intermediate-/high-risk prostate cancer undergoing radical prostatectomy and lymph node dissection, Gallium 68 prostate-specific membrane antigen (⁶⁸Ga-PSMA)-11 positron emission tomographic (PET) imaging shows sensitivity and specificity of 0.40 and 0.95, respectively.

Major finding: Compared with histopathology, ⁶⁸Ga-PSMA-11 PET imaging showed a sensitivity, specificity, positive predictive value, and negative predictive value for pelvic nodal metastases of 0.40, 0.95, 0.75, and 0.81, respectively.

Study details: A single-arm, open-label, phase 3 imaging trial (NCT03368547, NCT02611882, and NCT02919111) of 764 patients with intermediate- to high-risk prostate cancer considered for prostatectomy who underwent ⁶⁸Ga-PSMA-11 PET scan.

Disclosures: This work is supported by grants from the National Cancer Institute, Prostate Cancer Foundation, Society of Nuclear Medicine and Molecular Imaging, Philippe Foundation Inc, ARC Foundation, German Research Foundation, Doctor Robert Pfleger Foundation, and Wiedenfeld Foundation. The authors received grants, personal fees, cooperation projects, and speaker/advisory/consulting fees; held a patent; and/or reported being founder/shareholder outside this work.

Source: Hope TA et al. JAMA Oncol. 2021 Sep 16. doi: 10.1001/jamaoncol.2021.3771.

Key clinical point: In patients with intermediate-/high-risk prostate cancer undergoing radical prostatectomy and lymph node dissection, Gallium 68 prostate-specific membrane antigen (⁶⁸Ga-PSMA)-11 positron emission tomographic (PET) imaging shows sensitivity and specificity of 0.40 and 0.95, respectively.

Major finding: Compared with histopathology, ⁶⁸Ga-PSMA-11 PET imaging showed a sensitivity, specificity, positive predictive value, and negative predictive value for pelvic nodal metastases of 0.40, 0.95, 0.75, and 0.81, respectively.

Study details: A single-arm, open-label, phase 3 imaging trial (NCT03368547, NCT02611882, and NCT02919111) of 764 patients with intermediate- to high-risk prostate cancer considered for prostatectomy who underwent ⁶⁸Ga-PSMA-11 PET scan.

Disclosures: This work is supported by grants from the National Cancer Institute, Prostate Cancer Foundation, Society of Nuclear Medicine and Molecular Imaging, Philippe Foundation Inc, ARC Foundation, German Research Foundation, Doctor Robert Pfleger Foundation, and Wiedenfeld Foundation. The authors received grants, personal fees, cooperation projects, and speaker/advisory/consulting fees; held a patent; and/or reported being founder/shareholder outside this work.

Source: Hope TA et al. JAMA Oncol. 2021 Sep 16. doi: 10.1001/jamaoncol.2021.3771.

Key clinical point: In patients with intermediate-/high-risk prostate cancer undergoing radical prostatectomy and lymph node dissection, Gallium 68 prostate-specific membrane antigen (⁶⁸Ga-PSMA)-11 positron emission tomographic (PET) imaging shows sensitivity and specificity of 0.40 and 0.95, respectively.

Major finding: Compared with histopathology, ⁶⁸Ga-PSMA-11 PET imaging showed a sensitivity, specificity, positive predictive value, and negative predictive value for pelvic nodal metastases of 0.40, 0.95, 0.75, and 0.81, respectively.

Study details: A single-arm, open-label, phase 3 imaging trial (NCT03368547, NCT02611882, and NCT02919111) of 764 patients with intermediate- to high-risk prostate cancer considered for prostatectomy who underwent ⁶⁸Ga-PSMA-11 PET scan.

Disclosures: This work is supported by grants from the National Cancer Institute, Prostate Cancer Foundation, Society of Nuclear Medicine and Molecular Imaging, Philippe Foundation Inc, ARC Foundation, German Research Foundation, Doctor Robert Pfleger Foundation, and Wiedenfeld Foundation. The authors received grants, personal fees, cooperation projects, and speaker/advisory/consulting fees; held a patent; and/or reported being founder/shareholder outside this work.

Source: Hope TA et al. JAMA Oncol. 2021 Sep 16. doi: 10.1001/jamaoncol.2021.3771.

Key clinical point: In patients with intermediate-/high-risk prostate cancer undergoing radical prostatectomy and lymph node dissection, Gallium 68 prostate-specific membrane antigen (⁶⁸Ga-PSMA)-11 positron emission tomographic (PET) imaging shows sensitivity and specificity of 0.40 and 0.95, respectively.

Major finding: Compared with histopathology, ⁶⁸Ga-PSMA-11 PET imaging showed a sensitivity, specificity, positive predictive value, and negative predictive value for pelvic nodal metastases of 0.40, 0.95, 0.75, and 0.81, respectively.

Study details: A single-arm, open-label, phase 3 imaging trial (NCT03368547, NCT02611882, and NCT02919111) of 764 patients with intermediate- to high-risk prostate cancer considered for prostatectomy who underwent ⁶⁸Ga-PSMA-11 PET scan.

Disclosures: This work is supported by grants from the National Cancer Institute, Prostate Cancer Foundation, Society of Nuclear Medicine and Molecular Imaging, Philippe Foundation Inc, ARC Foundation, German Research Foundation, Doctor Robert Pfleger Foundation, and Wiedenfeld Foundation. The authors received grants, personal fees, cooperation projects, and speaker/advisory/consulting fees; held a patent; and/or reported being founder/shareholder outside this work.

Source: Hope TA et al. JAMA Oncol. 2021 Sep 16. doi: 10.1001/jamaoncol.2021.3771.

Key clinical point: In patients with intermediate-/high-risk prostate cancer undergoing radical prostatectomy and lymph node dissection, Gallium 68 prostate-specific membrane antigen (⁶⁸Ga-PSMA)-11 positron emission tomographic (PET) imaging shows sensitivity and specificity of 0.40 and 0.95, respectively.

Major finding: Compared with histopathology, ⁶⁸Ga-PSMA-11 PET imaging showed a sensitivity, specificity, positive predictive value, and negative predictive value for pelvic nodal metastases of 0.40, 0.95, 0.75, and 0.81, respectively.

Study details: A single-arm, open-label, phase 3 imaging trial (NCT03368547, NCT02611882, and NCT02919111) of 764 patients with intermediate- to high-risk prostate cancer considered for prostatectomy who underwent ⁶⁸Ga-PSMA-11 PET scan.

Disclosures: This work is supported by grants from the National Cancer Institute, Prostate Cancer Foundation, Society of Nuclear Medicine and Molecular Imaging, Philippe Foundation Inc, ARC Foundation, German Research Foundation, Doctor Robert Pfleger Foundation, and Wiedenfeld Foundation. The authors received grants, personal fees, cooperation projects, and speaker/advisory/consulting fees; held a patent; and/or reported being founder/shareholder outside this work.

Source: Hope TA et al. JAMA Oncol. 2021 Sep 16. doi: 10.1001/jamaoncol.2021.3771.

Key clinical point: In patients with intermediate-/high-risk prostate cancer undergoing radical prostatectomy and lymph node dissection, Gallium 68 prostate-specific membrane antigen (⁶⁸Ga-PSMA)-11 positron emission tomographic (PET) imaging shows sensitivity and specificity of 0.40 and 0.95, respectively.

Major finding: Compared with histopathology, ⁶⁸Ga-PSMA-11 PET imaging showed a sensitivity, specificity, positive predictive value, and negative predictive value for pelvic nodal metastases of 0.40, 0.95, 0.75, and 0.81, respectively.

Study details: A single-arm, open-label, phase 3 imaging trial (NCT03368547, NCT02611882, and NCT02919111) of 764 patients with intermediate- to high-risk prostate cancer considered for prostatectomy who underwent ⁶⁸Ga-PSMA-11 PET scan.

Disclosures: This work is supported by grants from the National Cancer Institute, Prostate Cancer Foundation, Society of Nuclear Medicine and Molecular Imaging, Philippe Foundation Inc, ARC Foundation, German Research Foundation, Doctor Robert Pfleger Foundation, and Wiedenfeld Foundation. The authors received grants, personal fees, cooperation projects, and speaker/advisory/consulting fees; held a patent; and/or reported being founder/shareholder outside this work.

Source: Hope TA et al. JAMA Oncol. 2021 Sep 16. doi: 10.1001/jamaoncol.2021.3771.