Study of Tamsulosin and/or Dutasteride to Relieve Urinary Symptoms After Brachytherapy for Localized Prostate Cancer
Information source: Case Comprehensive Cancer Center
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Prostate Cancer
Intervention: tamsulosin and/or dutasteride (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Case Comprehensive Cancer Center Official(s) and/or principal investigator(s): Jay P Ciezki, MD, Principal Investigator, Affiliation: Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center
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.
Clinical Details
Official title: A Randomized Trial of Tamsulosin and/or Dutasteride Versus Placebo to Relieve Urinary Symptoms After Brachytherapy for the Treatment of Localized Prostate Cancer
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double-Blind, Primary Purpose: Treatment
Primary outcome: 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.
Secondary outcome: Use of intermittent self-catheterization
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.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Male.
Criteria:
Inclusion Criteria:
- 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 Criteria:
- 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
Locations and Contacts
Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center, Cleveland, Ohio 44195, United States
Additional Information
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Starting date: November 2005
Last updated: May 3, 2011
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