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


Phase 3
18 Years
N/A
Not Enrolling
Male
Prostate Cancer

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Trial Information

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.


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Outcome Measure:

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.

Principal Investigator

Jay P Ciezki, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center

Authority:

United States: Food and Drug Administration

Study ID:

CASE14804

NCT ID:

NCT00244309

Start Date:

November 2005

Completion Date:

June 2006

Related Keywords:

  • Prostate Cancer
  • brachytherapy
  • urinary symptoms
  • Prostatic Neoplasms

Name

Location

Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer CenterCleveland, Ohio  44195