Spots Global Cancer Trial Database for Sildenafil in Treating Erectile Dysfunction in Patients With Prostate Cancer
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Trial Identification
Brief Title: Sildenafil in Treating Erectile Dysfunction in Patients With Prostate Cancer
Official Title: Treatment Of Erectile Dysfunction In Patients Treated On RTOG-9910 For Prostate Cancer: Impact On Patient And Partner Quality Of Life
Study ID: NCT00057759
Study Description
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.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: MALE
Healthy Volunteers: No
Locations
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
Fox Chase Virtua Health Cancer Program - Marlton, Marlton, New Jersey, United States
Community Regional Cancer Center at Community Medical Center, Toms River, New Jersey, United States
Roswell Park Cancer Institute, Buffalo, New York, United States
CCOP - North Shore University Hospital, Manhasset, New York, United States
Akron City Hospital, Akron, Ohio, United States
Cancer Research UK Medical Oncology Unit at Churchill Hospital & Weatherall Institute of Molecular Medicine - Oxford, Salem, Ohio, United States
Cancer Treatment Center, Wooster, Ohio, United States
LaFortune Cancer Center at St. John Medical Center, Tulsa, Oklahoma, United States
Natalie Warren Bryant Cancer Center at St. Francis Hospital, Tulsa, Oklahoma, United States
Bryn Mawr Hospital, Bryn Mawr, Pennsylvania, United States
Paoli Memorial Hospital, Paoli, Pennsylvania, United States
Albert Einstein Cancer Center, Philadelphia, Pennsylvania, United States
CCOP - MainLine Health, Wynnewood, Pennsylvania, United States
Lankenau Cancer Center at Lankenau Hospital, Wynnewood, Pennsylvania, United States
LDS Hospital, Salt Lake City, Utah, United States
Naval Medical Center - Portsmouth, Portsmouth, Virginia, United States
Gundersen Lutheran Cancer Center at Gundersen Lutheran Medical Center, La Crosse, Wisconsin, United States
Community Memorial Hospital, Menomonee Falls, Wisconsin, United States
Medical College of Wisconsin Cancer Center, Milwaukee, Wisconsin, United States
Veterans Affairs Medical Center - Milwaukee (Zablocki), Milwaukee, Wisconsin, United States
Contact Details
Name: Deborah Watkins Bruner, RN, PhD
Affiliation: Fox Chase Cancer Center
Role: STUDY_CHAIR
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