Sildenafil in Treating Erectile Dysfunction in Patients With Prostate Cancer
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|ClinicalTrials.gov Identifier: NCT00057759|
Recruitment Status : Completed
First Posted : April 9, 2003
Last Update Posted : November 17, 2015
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.
|Condition or disease||Intervention/treatment||Phase|
|Prostate Cancer Psychosocial Effects of Cancer and Its Treatment Radiation Toxicity Sexual Dysfunction Sexuality and Reproductive Issues||Drug: sildenafil citrate Other: Placebo||Not Applicable|
- 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 (Clinical Trial)|
|Actual Enrollment :||115 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Quadruple (Participant, Care Provider, 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|
|Study Start Date :||January 2003|
|Actual Primary Completion Date :||December 2006|
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.
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00057759
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|Study Chair:||Deborah Watkins Bruner, RN, PhD||Fox Chase Cancer Center|