Trial Information

Summary: Efficacy of combined prophylactic and on demand Sildenafil usage in potent men undergoing brachytherapy and hormonal therapy for localized prostate cancer.

The purpose of the study is to find out if taking Sildenafil (Viagra) can help preserve erectile function and/or prevent erectile dysfunction (known as ED or impotence) in men who are receiving certain treatments (hormone & brachytherapy ) for prostate cancer.
No Compensation Provided

Patient Inclusion/Exclusion Criteria:

a. Male aged >30 and <80 years.
b. Has localized prostate cancer who elect to undergo a combined hormone therapy and brachytherapy.
c. Has moderate erectile dysfunction or with no erectile dysfunction.
d. Understands the study procedures & agrees to participate by providing written informed consent.
e. Anticipate having the same adult female sexual study partner during the study.
f. Agree not to use any other ED treatment during the study.

a. Has a history of penile implant or significant penile deformity.
b. Has a clinically significant kidney and/or liver disease.
c. Has a chronic stable angina treated with long-acting nitrates (contained in heart medicines).
d. Has an unstable angina within 6 months, or has a history of sudden cardiac arrest or heart bypass surgery within the past 90 days.
e. Has a history of uncontrolled cardiac arrythmia, or has a new abnormally slow heart rate within the past 90 days.
f. Has a history of Human Immunodeficiency Virus(HIV)infection.
g. Has currently received treatment with nitrates, cancer chemotherapy, or antiandrogens.
h. Has participated in an investigational study within the past 30 days.

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: June 1, 2008 at 5:45:45 AM


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