Sildenafil in Treating Erectile Dysfunction in Patients With Prostate Cancer
Prostate Cancer, Psychosocial Effects of Cancer and Its Treatment, Radiation Toxicity
About this trial
This is an interventional supportive care trial for Prostate Cancer focused on measuring sexual dysfunction, sexuality and reproductive issues, radiation toxicity, stage IIB prostate cancer, stage IIA prostate cancer, stage III prostate cancer, psychosocial effects of cancer and its treatment
Eligibility Criteria
DISEASE CHARACTERISTICS: Prior treatment on RTOG-9910 for intermediate relapse-risk stage II or III prostate cancer as determined by any of the following combinations of factors: T1b-4, Gleason score 2-6, and prostate-specific antigen (PSA) greater than 10 ng/mL but no greater than 100 ng/mL T1b-4, Gleason score 7, and PSA less than 20 ng/mL T1b-1c, Gleason score 8-10, and PSA less than 20 ng/mL Radiotherapy completed within the past 6 months to 5 years Pretreatment (before enrollment on this study) erectile dysfunction as measured by International Index of Erectile Function Question #1 Erectile dysfunction before starting prostate cancer therapy allowed Patients without partners or without partners willing to participate allowed PATIENT CHARACTERISTICS: Age 18 and over Performance status Zubrod 0-2 Life expectancy Not specified Hematopoietic Not specified Hepatic Not specified Renal Not specified Cardiovascular No myocardial infarction within the past year Other No other invasive cancer within the past 5 years except localized basal cell or squamous cell skin cancer (stage 0-II) No anatomical genital abnormalities or concurrent conditions that would prohibit sexual intercourse or preclude study participation No other major medical or psychiatric illness that would preclude study participation PRIOR CONCURRENT THERAPY: Biologic therapy Not specified Chemotherapy Not specified Endocrine therapy More than 6 months since prior androgen suppression (e.g., leuprolide or goserelin), antiandrogen (e.g., bicalutamide, flutamide, or nilutamide), or estrogenic (e.g., diethylstilbestrol) agents Radiotherapy See Disease Characteristics Surgery No prior penile implant No prior bilateral orchiectomy Other No concurrent sildenafil No concurrent participation in another medical research study to treat prostate cancer No concurrent organic nitrate or requirement for nitrates (e.g., nitroglycerin as needed) No concurrent ketoconazole, itraconazole, or erythromycin No concurrent use of mechanical (vacuum) devices or intracorporeal, intraurethral, topical, or oral agents for erectile dysfunction
Sites / Locations
- Mount Diablo Regional Cancer Center
- Cancer Care Consultants Medical Associates at Daniel Freeman Memorial Hospital
- John Muir/Mt. Diablo Comprehensive Cancer Center
- Cape Cod Hospital
- University of Michigan Comprehensive Cancer Center
- West Michigan Cancer Center
- St. John's Regional Health Center
- Hulston Cancer Center at Cox Medical Center South
- Washoe Cancer Services at Washoe Medical Center - Reno
- Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center
- Fox Chase Virtua Health Cancer Program - Marlton
- Community Regional Cancer Center at Community Medical Center
- Roswell Park Cancer Institute
- CCOP - North Shore University Hospital
- Akron City Hospital
- Cancer Research UK Medical Oncology Unit at Churchill Hospital & Weatherall Institute of Molecular Medicine - Oxford
- Cancer Treatment Center
- LaFortune Cancer Center at St. John Medical Center
- Natalie Warren Bryant Cancer Center at St. Francis Hospital
- Bryn Mawr Hospital
- Paoli Memorial Hospital
- Albert Einstein Cancer Center
- CCOP - MainLine Health
- Lankenau Cancer Center at Lankenau Hospital
- LDS Hospital
- Naval Medical Center - Portsmouth
- Gundersen Lutheran Cancer Center at Gundersen Lutheran Medical Center
- Community Memorial Hospital
- Medical College of Wisconsin Cancer Center
- Veterans Affairs Medical Center - Milwaukee (Zablocki)
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
Sildenafil citrate
Placebo
Sildenafil with dose escalation as needed from 50 mg to 100 mg/day prn for 12 weeks.
Placebo with similar "dose escalation" opportunity for 12 weeks.