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Randomized Study of Sildenafil for Erectile Dysfunction in Patients With Prostate Cancer Treated on RTOG-9910
Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Published Results
Trial Contact Information
Related Information
Registry Information
Alternate Title
Sildenafil in Treating Erectile Dysfunction in Patients With Prostate Cancer
Basic Trial Information
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Phase
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Status
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Protocol IDs
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No phase specified
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Supportive care
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Completed
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18 and over
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NCI
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RTOG-0215
NCI-P-02-0234, RTOG 0215, NCT00057759
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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.
Entry 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
Prior/Concurrent Therapy:
Biologic therapy Chemotherapy 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., diethylstibestrol) 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
Patient Characteristics:
Age Performance status Life expectancy Hematopoietic Hepatic Renal 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
Expected Enrollment A total of 332 patients (166 per treatment arm) will be accrued for this study. 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 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. Published ResultsBruner DW, James J, Pisansky TM, et al.: RTOG 0215 treatment of erectile dysfunction (ED) in patients treated with neoadjuvant and concurrent androgen deprivation (AD) and radiotherapy (RT) for prostate cancer (PC). [Abstract] Int J Radiat Oncol Biol Phys 69 (3 Suppl): A-52, S30, 2007.
Trial Contact Information
Trial Lead Organizations Radiation Therapy Oncology Group | | | | Deborah Watkins Bruner, RN, PhD, Protocol chair | | | Ph: 215-728-2707; 888-369-2427 |
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Related Information PDQ® clinical trial RTOG-9910
| Registry Information | | | Official Title | | Treatment Of Erectile Dysfunction In Patients Treated On RTOG-9910 For Prostate Cancer: Impact On Patient And Partner Quality Of Life | | | Trial Start Date | | 2003-01-31 | | | Registered in ClinicalTrials.gov | | NCT00057759 | | | Date Submitted to PDQ | | 2002-09-10 | | | Information Last Verified | | 2006-11-02 |
Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol. |
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