NCT00244309

Study of Tamsulosin and/or Dutasteride to Relieve Urinary Symptoms After Brachytherapy for Localized Prostate Cancer

A Randomized Trial of Tamsulosin and/or Dutasteride Versus Placebo to Relieve Urinary Symptoms After Brachytherapy for the Treatment of Localized Prostate Cancer

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 348 (estimated)
• Sponsor: Case Comprehensive Cancer Center · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine whether a drug named tamsulosin (Flomax), or another drug named dutasteride (Avodart), or a combination of these two drugs is effective in improving urinary symptoms and decreasing the rate of intermittent self-catheterization after prostate brachytherapy.

Detailed description

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.

Conditions

• Prostate Cancer

Interventions

Type	Name	Description
DRUG	tamsulosin and/or dutasteride

Timeline

• Start date: 2005-11-01
• Primary completion: 2006-06-01
• Completion: 2006-06-01
• First posted: 2005-10-26
• Last updated: 2011-05-04

Locations

1 site across 1 country: United States