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Treatment Of Erectile Dysfunction In Patients Treated On RTOG-9910 For Prostate Cancer: Impact On Patient And Partner Quality Of Life
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.
Age
18 - No limit years
Sex
MALE
Healthy Volunteers
No
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
Start Date
January 1, 2003
Primary Completion Date
December 1, 2006
Last Updated
November 17, 2015
115
ACTUAL participants
sildenafil citrate
DRUG
Placebo
OTHER
Lead Sponsor
Radiation Therapy Oncology Group
Collaborators
NCT04550494
NCT06842498
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT05691465