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Home > "S" Clinical Trials Conditions > Sildenafil in Treating Erectile Dysfunction in Patients With Prostate Cancer  Sildenafil in Treating Erectile Dysfunction in Patients With Prostate Cancer
Sildenafil in Treating Erectile Dysfunction in Patients With Prostate Cancer
For Condition: psychosocial effects/treatment,stage 3 prostate cancer,stage 2 prostate cancer,sexual dysfunction and infertility,sexuality and reproductive issues,radiation toxicity
Status: Recruiting
Sponsor(s): Radiation Therapy Oncology Group , National Cancer Institute (NCI)
Synopsis: 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.
Details: 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:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol 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 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
Total Enrollment:
Location and Contact Information:
Overall Study Official:
DeborahBruner, Study Chair, Fox Chase Cancer Center
Norris Cotton Cancer Center at Dartmouth Medical School *Recruiting*
Lebanon, New Hampshire, 03756-0002
United States
Recruiting Eugen Hug 603-650-6600
Foundation for Cancer Research and Education *Recruiting*
Phoenix, Arizona, 85013
United States
Recruiting David Brachman 602-274-4484
Additional Information:
Study ID Numbers: CDR0000269135; NCI-P-02-0234,RTOG-0215
Study Start Date:
Record last reviewed: December 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00057759
Other Psychosocial Effects/treatment Studies:
1. Parotid-Sparing Intensity-Modulated Radiation Therapy Compared With Conventional Radiation Therapy in Treating Patients With Oropharyngeal or Hypopharyngeal Cancer Who Are at High Risk of Radiation-Induced Xerostomia
2. Melatonin and Radiation Therapy in Treating Patients With Brain Metastases
3. Radiation Therapy, Combination Chemotherapy, and Amifostine Followed by Surgery to Remove the Esophagus in Treating Patients With Locally Advanced Cancer of the Esophagus
4. Donepezil and EGb761 in Improving Neurocognitive Function in Patients Who Have Previously Undergone Radiation Therapy for Primary Brain Tumor or Brain Metastases
5. Radiation Therapy in Treating Patients With Stage II or Stage III Oropharyngeal Cancer
Related Studies:
Other psychosocial effects/treatment Clinical Trials
Other New Hampshire Clinical Trials
Other Lebanon Clinical Trials
Sildenafil in Treating Erectile Dysfunction in Patients With Prostate Cancer
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