Trial Information
Summary: Randomized Prospective Study Comparing Prophylactic and On Demand Sildenafil Citrate Usage Administered During and After Radiotherapy in Combination with or without Hormone Therapy versus Radiotherapy Alone for the Preservation of Erectile Function in Potent Patients with Clinically Localized Prostate Cancer.
The purpose of this study is to find out if taking Sildenafil (Viagra)can help preserve erectile function and/or reduce the risk of long-term erectile dysfunction (known as ED or impotence) in men who are receiving radiotherapy with or without hormone therapy for prostate cancer.
No Compensation Provided
Patient Inclusion/Exclusion Criteria:
1. To receive radiation treatment with or without hormone therapy for biopsy-proven prostate cancer.
2. Baseline International Index of Erectile Function (IIEF) erectile function domain score of equal to or greater than 17.
1. History of Peyronie's disease, penile implant, prostate radiotherapy or cryotherapy.
2. Currently taking nitrate medication (commonly used to treat chest pain caused by heart disease), Flomax 0.8 mg.
3. Has an unstable angina within 6 months, or has a history of sudden cardiac arrest, myocardial infarction or heart bypass surgery within the past 90 days.
4. Has a history of uncontrolled irregular heart beat, or has a new abnormally slow heart rate within the past 90 days.
5. Has currently received treatment with nitrates, cancer chemotherapy, or antiandrogens (medication used to prevent production or activity of male sex hormone), except finasteride taken as Propecia or Proscar.
6. Have history of drug, alcohol, or substance abuse within the past 6 months.
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Contact:
Lourdes Campos-Grundvig, RN, MS
Mount Sinai Medical Center
One Gustave L. Levy Place
New York, NY 10029
Telephone: (212) 241-3141
Fax: (212) 876-3246
Email:
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Trial listings updated: July 10, 2008 at 2:50:54 PM