Radiation Oncology/RTOG Trials/0215

RTOG 02-15 (PROSTATE) Title: Treatment of Erectile Dysfunction In Patients Treated With Neoadjuvant Androgen Suppression and Radiotherapy for Prostate Cancer: Impact on Patient and Partner Quality of Life Objectives: (1) To determine if there is a difference in erectile function between men treated with sildenafil versus placebo after radiation therapy + antiandrogens for prostate cancer (2) To determine if there is a difference in overall sexual function and satisfaction between men treated with sildenafil versus placebo after radiation therapy + antiandrogens for prostate cancer (3) To determine if there is a difference in partner sexual satisfaction between the sildenafil versus placebo arms of this study (4) To determine if there is a difference in patient and partner marital adjustment between the sildenafil versus placebo arms of this study (5)To assess factors that may predict response to sildenafil therapy (for example: age, pretreatment sexual function, tobacco use, and comorbidities) Protocol: Arm 1: Sildenafil with dose escalation PRN from 50 to 100 mg/day PRN x 12 weeks --> CROSSOVER @ 13 weeks --> Placebo with similar “dose escalation” opportunity x 12 weeks Arm 2: Placebo with similar “dose escalation” opportunity x 12 weeks --> CROSSOVER @ 13 weeks --> Sildenafil with dose escalation PRN from 50 to 100 mg/day PRN x 12 weeks Eligibility: cT1-T4, M0 Enrollment Target: 332 patients Activation: January 3, 2003 Conclusion: 21235716 -- Randomized, double-blinded, placebo-controlled crossover trial of treating erectile dysfunction with sildenafil after radiotherapy and short-term androgen deprivation therapy: results of RTOG 0215. (Watkins Bruner D, J Sex Med. 2011). Conclusion: This is the first controlled trial to suggest a positive sildenafil response for ED treatment in patients previously treated with RT/ADT, however, only a minority of patients responded to treatment. ADT duration may be associated with response and requires further study. The overall low response rate suggests the need for study of additional or preventative strategies for ED after RT/ADT for prostate cancer. Publications: 22354624 -- Impact of sildenafil on marital and sexual adjustment in patients and their wives after radiotherapy and short-term androgen suppression for prostate cancer: analysis of RTOG 0215. (Hanisch LJ, Support Care Cancer. 2012) Conclusion: Larger studies are warranted to further examine possible differences in sexual experiences and treatment needs between prostate cancer patients and their wives, as well as to assess predictors of sildenafil response.