Sildenafil in Treating Erectile Dysfunction in Patients With Prostate Cancer
- Conditions
- Sexual DysfunctionSexuality and Reproductive IssuesProstate CancerRadiation ToxicityPsychosocial Effects of Cancer and Its Treatment
- Interventions
- Other: Placebo
- Registration Number
- NCT00057759
- Lead Sponsor
- Radiation Therapy Oncology Group
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 115
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Placebo Placebo Placebo with similar "dose escalation" opportunity for 12 weeks. Sildenafil citrate sildenafil citrate Sildenafil with dose escalation as needed from 50 mg to 100 mg/day prn for 12 weeks.
- Primary Outcome Measures
Name Time Method Ability to obtain an erection, as measured by question 1 on the IIEF From baseline to 12 weeks from the start of drug after crossover
- Secondary Outcome Measures
Name Time Method Partner sexual satisfaction as measured by the SAQ-Partner 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 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) From baseline to 12 weeks from the start of drug after crossover Predictors of erectile dysfunction therapy From baseline to 12 weeks from the start of drug after crossover
Related Research Topics
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Trial Locations
- Locations (30)
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
West Michigan Cancer Center
🇺🇸Kalamazoo, Michigan, United States
St. John's Regional Health Center
🇺🇸Springfield, Missouri, United States
Hulston Cancer Center at Cox Medical Center South
🇺🇸Springfield, Missouri, United States
Washoe Cancer Services at Washoe Medical Center - Reno
🇺🇸Reno, Nevada, United States
Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center
🇺🇸Lebanon, New Hampshire, United States
Scroll for more (20 remaining)Mount Diablo Regional Cancer Center🇺🇸Concord, California, United States