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Postoperative radiation therapy (RT) is an underused standard-of-care intervention for patients with prostate cancer and recurrence/adverse pathologic features after radical prostatectomy. Although stereotactic body RT (SBRT) is a well-studied and convenient option for definitive treatment, data on the postprostatectomy setting are extremely limited. The purpose of this study was to evaluate short-term physician-scored genitourinary (GU) and gastrointestinal (GI) toxicities and patient-reported outcomes after postprostatectomy SBRT.The SCIMITAR trial was a phase 2, dual-center, open-label, single-arm trial that enrolled patients with postoperative prostate-specific antigen0.03 ng/mL or adverse pathologic features. Coprimary endpoints were 4-year biochemical recurrence-free survival, physician-scored acute and late GU and GI toxicities by the Common Terminology Criteria for Adverse Events (version 4.03) scale, and patient-reported quality-of-life (QOL) outcomes, as represented by the Expanded Prostate Cancer Index-26 and the International Prostate Symptom Score. Patients received SBRT 30 to 34 Gy/5 fractions to the prostate bed ± bed boost ± pelvic nodes with computed tomography (CTgRT) or magnetic resonance imaging guidance (MRgRT) in a nonrandomized fashion. Physician-scored toxicities and patient-reported QOL outcomes were collected at baseline and at 1, 3, and 6 months of follow-up. Univariable and multivariable analyses were performed to evaluate predictors of toxicities and QOL outcomes.One hundred participants were enrolled (CTgRT, n = 69; MRgRT, n = 31). The median follow-up was 29.5 months (CTgRT: 33.3 months, MRgRT: 22.6 months). The median (range) prostate bed dose was 32 (30-34) Gy. Acute and late grade 2 GU toxicities were both 9% while acute and late grade 2 GI toxicities were 5% and 0%, respectively. Three patients had grade 3 toxicity (n = 1 GU, n = 2 GI). No patient receiving MRgRT had grade 3 GU or grade ≥2 GI toxicity. Compared with CTgRT, MRgRT was associated with a 30.5% (95% confidence interval, 11.6%-49.5%) reduction in any-grade acute GI toxicity (P = .006). MRgRT was independently associated with improved any-grade GI toxicity and improved bowel QOL.Postprostatectomy SBRT was well tolerated at short-term follow-up. MRgRT may decrease GI toxicity. Longer toxicity and/or efficacy follow-up and randomized studies are needed.

Key Points Question Is there a difference in outcomes between Black and White men with localized prostate cancer receiving definitive radiotherapy (RT)? Findings In this meta-analysis that included 8814 patients treated with definitive RT enrolled in 7 randomized clinical trials, Black men were significantly less likely to experience a biochemical recurrence, distant metastasis, and prostate cancer–specific mortality event than White men. Meaning The findings of this meta-analysis noted that Black men enrolled in randomized clinical trials presented with more aggressive disease features but had better treatment and disease-specific outcomes with RT-based therapy compared with White men, suggesting other important factors associated with outcome, such as access to care, as sources of disparity., Importance Black men have a 2-fold increased risk of dying from prostate cancer compared with White men. However, race-specific differences in response to initial treatment remain unknown. Objective To compare overall and treatment-specific outcomes of Black and White men with localized prostate cancer receiving definitive radiotherapy (RT). Data Sources A systematic search was performed of relevant published randomized clinical trials conducted by the NRG Oncology/Radiation Therapy Oncology Group between January 1, 1990, and December 31, 2010. This meta-analysis was performed from July 1, 2019, to July 1, 2021. Study Selection Randomized clinical trials of definitive RT for patients with localized prostate cancer comprising a substantial number of Black men (self-identified race) enrolled that reported on treatment-specific and overall outcomes. Data Extraction and Synthesis Individual patient data were obtained from 7 NRG Oncology/Radiation Therapy Oncology Group randomized clinical trials evaluating definitive RT with or without short- or long-term androgen deprivation therapy. Unadjusted Fine-Gray competing risk models, with death as a competing risk, were developed to evaluate the cumulative incidences of end points. Cox proportional hazards models were used to evaluate differences in all-cause mortality and the composite outcome of distant metastasis (DM) or death. The Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guideline was followed. Main Outcomes and Measures Subdistribution hazard ratios (sHRs) of biochemical recurrence (BCR), DM, and prostate cancer-specific mortality (PCSM). Results A total of 8814 patients (1630 [18.5%] Black and 7184 [81.5%] White) were included; mean (SD) age was 69.1 (6.8) years. Median follow-up was 10.6 (IQR, 8.0-17.8) years for surviving patients. At enrollment, Black men were more likely to have high-risk disease features. However, even without adjustment, Black men were less likely to experience BCR (sHR, 0.88; 95% CI, 0.58-0.91), DM (sHR, 0.72; 95% CI, 0.58-0.91), or PCSM (sHR, 0.72; 95% CI, 0.54-0.97). No significant differences in all-cause mortality were identified (HR, 0.99; 95% CI, 0.92-1.07). Upon adjustment, Black race remained significantly associated with improved BCR (adjusted sHR, 0.79; 95% CI, 0.72-0.88; P, This meta-analysis assesses treatment-specific outcomes associated with receipt of definitive radiotherapy in Black and White men with localized prostate cancer.

Purpose The long-term effects of neoadjuvant androgen deprivation therapy (NADT) with radiation therapy on participant-reported health-related quality of life (HRQOL) have not been characterized in prospective multicenter studies. We evaluated HRQOL for 2 years among participants undergoing radiation therapy (RT) with or without NADT for newly diagnosed, early-stage prostate cancer. Methods and Materials We analyzed longitudinal cohort data from the Prostate Cancer Outcomes and Satisfaction with Treatment Quality Assessment Consortium to ascertain the HRQOL trajectory of men receiving NADT with external beam RT (EBRT) or brachytherapy. HRQOL was measured using the expanded prostate cancer index composite 26-item questionnaire at 2, 6, 12, and 24 months after the initiation of NADT. We used the χ 2 or Fisher exact test to compare the shift in percentages between groups that did or did not receive NADT. Analyses were conducted at the 2-sided 5% significance level. Results For subjects receiving EBRT, questions regarding the ability to have an erection, ability to reach an orgasm, quality of erections, frequency of erections, ability to function sexually, and lack of energy were in a significantly worse dichotomized category for the patients receiving NADT. Comparing the baseline versus 24-month outcomes, 24%, 23%, and 30% of participants receiving EBRT plus NADT shifted to the worse dichotomized category for the ability to reach an orgasm, quality of erections, and ability to function sexually compared with 14%, 13%, and 16% in the EBRT group, respectively. Conclusions Compared with baseline, at 2 years, participants receiving NADT plus EBRT compared with EBRT alone had worse HRQOL, as measured by the ability to reach orgasm, quality of erections, and ability to function sexually. However, no difference was found in the ability to have an erection, frequency of erections, overall sexual function, hot flashes, breast tenderness/enlargement, depression, lack of energy, or change in body weight. The improved survival in intermediate- and high-risk patients receiving NADT and EBRT necessitates pretreatment counseling of the HRQOL effect of NADT and EBRT.

51 Background: RP, EBRT, and PI for the treatment of clinically localized prostate cancer may negatively impact sexual function. Predictions of treatment-related sexual problems from patient-reported, prospective data may be useful in decision-making. Methods: Patient-reported data on treatment-related sexual problems was obtained from 4 prospective, longitudinal, health-related quality-of-life (HRQOL) protocols comprising 2,668 patients treated between 1999 and 2011 by RP (n = 1,294), EBRT (n = 630), and PI (n = 744). A single HRQOL instrument was not uniformly used for each study, although questions pertaining to the quality and frequency of erections were identical among the studies. Only those patients with quality of erections sufficient for intercourse were included in the model. The endpoint of the model was erections suitable for intercourse on at least half of attempts at 2 years after treatment, with or without the use of oral medications. Cox proportional hazards regression analysis was used to model the clinical information and follow-up data. Internal validation was performed using bootstrapping. Results: Overall, 931 (74%), 249 (42%), and 323 (45%) patients treated by RP, EBRT, and PI were considered to be potent at baseline. Significant differences in baseline characteristics such as patient age, ethnicity, and disease severity existed between the treatment groups. The potency rate at 2 years for 1,215 patients who were potent at baseline and had complete follow-up data was 38%, 51%, and 61% for patients treated by RP, EBRT, and PI, respectively (p < 0.001). In multivariable analysis, age (p < 0.001), baseline frequency of erections (p < 0.001), EBRT (p < 0.001), PI (p < 0.001), PSA (p = 0.001), and institution (p = 0.006), were associated with potency. A nomogram based on the predictive parameters had a concordance index of 0.72 and predictions were well-calibrated with observed outcome. Conclusions: An externally-validated nomogram that predicts 2-year potency after treatment for localized prostate cancer has been developed and may be useful for patient counseling regarding treatment options.

55 Background: RP, EBRT, and PI for treatment of clinically localized prostate cancer may negatively impact bowel function. Predictions of treatment-related bowel problems from patient-reported, prospective data may be useful in treatment decision-making. Methods: Patient-reported data on treatment-related bowel problems was obtained from 4 prospective, longitudinal, health-related quality-of-life (HRQOL) protocols comprising 2,668 patients treated between 1999 and 2011 by RP (n=1294), EBRT (n=630), and PI (n=744). A single HRQOL instrument was not uniformly used for each study, though all patients were asked if they experienced bother related to bowel problems using a similar 5-point scale. Patient responses were obtained at baseline and at 2 years after treatment. The endpoint of the model was bowel dysfunction, defined as bowel symptoms that were identified as a moderate-to-big problem. Cox proportional hazards regression analysis was used to model the clinical information and follow-up data. Internal validation was performed using bootstrapping. Results: Significant differences in baseline characteristics such as patient age, ethnicity, and disease severity existed between the treatment groups. Overall, 46 patients (2%) with complete data available had bowel dysfunction at baseline, including 11 (1%), 19 (4%), and 16 (3%) patients treated by RP, EBRT, and PI, respectively (p = 0.001). The overall rate of bowel dysfunction at 2 years in those patients with no bowel dysfunction at baseline was 2%, 10%, and 4% for patients treated by RP, EBRT, and PI, respectively (p < 0.001). In multivariable analysis, EBRT (p < 0.001), PI (p < 0.001), baseline bowel symptoms (p < 0.001), and institution (p = 0.04) were associated with bowel dysfunction. A nomogram based on the predictive parameters had a concordance index of 0.73 and predictions were well-calibrated with observed outcome. Conclusions: An externally validated nomogram that predicts 2-year incidence of bowel dysfunction after treatment for localized prostate cancer has been developed and may be useful for patient counseling regarding treatment options.