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.
OBJECTIVES: * 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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE
Enrollment
115
Placebo
Mount Diablo Regional Cancer Center
Concord, California, United States
Cancer Care Consultants Medical Associates at Daniel Freeman Memorial Hospital
Inglewood, California, United States
John Muir/Mt. Diablo Comprehensive Cancer Center
Walnut Creek, California, United States
Cape Cod Hospital
Hyannis, Massachusetts, United States
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, United States
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
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
Partner sexual satisfaction as measured by the SAQ-Partner
Time frame: From baseline to 12 weeks from the start of drug after crossover
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
Predictors of erectile dysfunction therapy
Time frame: From baseline to 12 weeks from the start of drug after crossover
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