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