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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

Related publications:

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Ragde H, Korb LJ, Elgamal AA, Grado GL, Nadir BS. Modern prostate brachytherapy. Prostate specific antigen results in 219 patients with up to 12 years of observed follow-up. Cancer. 2000 Jul 1;89(1):135-41.

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Starting date: November 2005
Last updated: May 3, 2011

Page last updated: August 20, 2015

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