Sildenafil in Treating Erectile Dysfunction in Patients With Prostate Cancer
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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 |
|---|---|
|
Prostate Cancer Psychosocial Effects of Cancer and Its Treatment Radiation Toxicity Sexual Dysfunction Sexuality and Reproductive Issues |
Drug: sildenafil citrate |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Primary Purpose: Supportive Care |
| 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:
- 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 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| 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:
- 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., 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
Contacts and Locations
Show 30 Study Locations| Study Chair: | Deborah Watkins Bruner, RN, PhD | Fox Chase Cancer Center |
More Information
Additional Information:
Publications:
| ClinicalTrials.gov Identifier: | NCT00057759 History of Changes |
| Obsolete Identifiers: | NCT00075127 |
| Other Study ID Numbers: | CDR0000269135, RTOG-0215, NCI-P-02-0234 |
| Study First Received: | April 7, 2003 |
| Last Updated: | March 1, 2012 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Cancer Institute (NCI):
|
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 |
Additional relevant MeSH terms:
|
Prostatic Neoplasms Sexual Dysfunctions, Psychological Erectile Dysfunction Radiation Injuries Genital Neoplasms, Male Urogenital Neoplasms Neoplasms by Site Neoplasms Genital Diseases, Male Prostatic Diseases Sexual and Gender Disorders Mental Disorders |
Sexual Dysfunction, Physiological Wounds and Injuries Sildenafil Vasodilator Agents Cardiovascular Agents Therapeutic Uses Pharmacologic Actions Phosphodiesterase 5 Inhibitors Phosphodiesterase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on June 17, 2013