Status:
COMPLETED
Study of Tamsulosin and/or Dutasteride to Relieve Urinary Symptoms After Brachytherapy for Localized Prostate Cancer
Lead Sponsor:
Case Comprehensive Cancer Center
Collaborating Sponsors:
GlaxoSmithKline
Conditions:
Prostate Cancer
Eligibility:
MALE
18+ years
Phase:
PHASE3
Brief 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 s...
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 re...
Eligibility Criteria
Inclusion
- Patient is eligible for a prostate implant
- Patient is greater than 18 years of age
- Patient is able to give informed consent
- Patient does not currently take Flomax, Dutasteride or Finasteride
- Patient does not have a known hypersensitivity reaction to Flomax or Dutasteride
Exclusion
- Patients who have a known hypersensitivity reaction to tamsulosin, dutasteride or finasteride and those patients who are already on any prior to prostate implantation
- Patients who are taking a PDE-5 inhibitor including sildenafil (Viagra), tadalafil (Cialis) and vardenafil (Levitra) are ineligible to participate unless they are willing to discontinue using those drugs one week prior to their implant and for three months after the implant
Key Trial Info
Start Date :
November 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2006
Estimated Enrollment :
348 Patients enrolled
Trial Details
Trial ID
NCT00244309
Start Date
November 1 2005
End Date
June 1 2006
Last Update
May 4 2011
Active Locations (1)
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1
Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center
Cleveland, Ohio, United States, 44195