Sildenafil in Treating Erectile Dysfunction in Patients With Prostate Cancer
RATIONALE: Sildenafil may be effective in helping patients who have undergone treatment for prostate cancer to have an erection for sexual activity and may improve sexual satisfaction and quality of life.
PURPOSE: Randomized clinical trial to study the effectiveness of sildenafil in treating erectile dysfunction in patients who have undergone radiation therapy and hormone therapy for prostate cancer in clinical trial RTOG-9910.
Psychosocial Effects of Cancer and Its Treatment
Sexuality and Reproductive Issues
Drug: sildenafil citrate
|Study Design:||Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
|Official Title:||Treatment Of Erectile Dysfunction In Patients Treated On RTOG-9910 For Prostate Cancer: Impact On Patient And Partner Quality Of Life|
- Ability to obtain an erection, as measured by question 1 on the IIEF [ Time Frame: From baseline to 12 weeks from the start of drug after crossover ] [ Designated as safety issue: No ]
- Overall sexual function and satisfaction as measured by the Sexual Adjustment Questionnaire (SAQ) [ Time Frame: From baseline to 12 weeks from the start of drug after crossover ] [ Designated as safety issue: No ]
- Partner sexual satisfaction as measured by the SAQ-Partner [ Time Frame: From baseline to 12 weeks from the start of drug after crossover ] [ Designated as safety issue: No ]
- Patient and spouse marital adjustment as measured by the Locke's Marital Adjustment Test [ Time Frame: From baseline to 12 weeks from the start of drug after crossover ] [ Designated as safety issue: No ]
- Predictors of erectile dysfunction therapy [ Time Frame: From baseline to 12 weeks from the start of drug after crossover ] [ Designated as safety issue: No ]
|Study Start Date:||January 2003|
|Primary Completion Date:||December 2006 (Final data collection date for primary outcome measure)|
Experimental: Sildenafil citrate
Sildenafil with dose escalation as needed from 50 mg to 100 mg/day prn for 12 weeks.
|Drug: sildenafil citrate|
Placebo Comparator: Placebo
Placebo with similar "dose escalation" opportunity for 12 weeks.
- Compare the effect of sildenafil vs placebo on erectile dysfunction in patients with prostate cancer treated with radiotherapy and antiandrogens on RTOG-9910.
- Compare the overall sexual function and satisfaction of patients treated with these regimens.
- Compare sexual satisfaction of partners of patients treated with these regimens.
- Compare patient and partner marital adjustment after treatment with these regimens.
- Determine factors that may predict response to sildenafil, including age, pretreatment sexual function, tobacco use, and comorbidities in these patients.
OUTLINE: This is a randomized, placebo-controlled, multicenter study. Patients are stratified according to prior use of sildenafil after treatment on RTOG-9910 and level of response (No vs yes [unsatisfactory] vs yes [satisfactory]), International Index of Erectile Function (IIEF) Question #1 score (0-1 vs 2-3), and RTOG-9910 treatment arm (I vs II). Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive oral sildenafil 1 hour prior to desired sexual intercourse.
- Arm II: Patients receive oral placebo 1 hour prior to desired sexual intercourse.
Treatment on both arms continues for 12 weeks. Patients then cross over to treatment on the other arm for 12 weeks.
Quality of life, including sexual function, marital adjustment, and partner's satisfaction, is assessed at baseline, at 12 and 25 weeks, and at 1 year.
Patients are followed at 1 year.
PROJECTED ACCRUAL: A total of 332 patients (166 per treatment arm) will be accrued for this study.