A Randomized Trial of Tamsulosin and/or Dutasteride Versus Placebo to Relieve Urinary Symptoms After Brachytherapy for the Treatment of Localized Prostate Cancer
Image-guided transperineal permanent prostate brachytherapy (PI) is an accepted curative
treatment option for patients with early stage prostate cancer. The most severe side effect
of PI is urinary retention requiring intermittent self-catheterization (ISC). This study
will assess the ability of pharmacologic intervention to ameliorate the post-operative side
effect of PI. The use of both tamsulosin and dutasteride is proposed to have benefit in
reducing urinary symptom score and in reducing the rate of intermittent self-catheterization
for patients with prostate adenocarcinoma after prostate implant.
Interventional
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double-Blind, Primary Purpose: Treatment
AUA score will be used to assess severity of urinary symptoms. All patients will be contacted weekly by telephone for 12 weeks then monthly postoperatively to get their AUA score. A total of 21 AUA scores postoperatively.
Jay P Ciezki, MD
Principal Investigator
Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center
United States: Food and Drug Administration
CASE14804
NCT00244309
November 2005
June 2006
Name | Location |
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Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center | Cleveland, Ohio 44195 |