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| Sponsors and Collaborators: |
Radiation Therapy Oncology Group National Cancer Institute (NCI) |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00057759 |
Purpose
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 | Intervention |
|
Cancer-Related Problem/Condition Prostate Cancer |
Drug: sildenafil citrate |
| MedlinePlus related topics: | Cancer Erectile Dysfunction Prostate Cancer |
| Drug Information available for: | Sildenafil citrate Sildenafil Citric acid Sodium Citrate |
| Study Type: | Interventional |
| Study Design: | Supportive Care, Randomized, Placebo Control |
| 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 |
OBJECTIVES:
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.
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
| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
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:
Pretreatment (before enrollment on this study) erectile dysfunction as measured by International Index of Erectile Function Question #1
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
Contacts and Locations![]() |
Show 30 Study Locations |
| Radiation Therapy Oncology Group |
| National Cancer Institute (NCI) |
| Study Chair: | Deborah Watkins Bruner, RN, PhD | Fox Chase Cancer Center |
More Information
Clinical trial summary from the National Cancer Institute's PDQ® database 
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Bruner 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.
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| Study ID Numbers: | CDR0000269135, RTOG-0215, NCI-P-02-0234 |
| First Received: | April 7, 2003 |
| Last Updated: | October 18, 2008 |
| ClinicalTrials.gov Identifier: | NCT00057759 |
| Health Authority: | United States: Federal Government |
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