Prostate Cancer Clinical Trial

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

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.

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Full 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.

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Eligibility 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

Study is for people with:

Prostate Cancer

Phase:

Phase 3

Estimated Enrollment:

348

Study ID:

NCT00244309

Recruitment Status:

Completed

Sponsor:

Case Comprehensive Cancer Center

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There is 1 Location for this study

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Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center
Cleveland Ohio, 44195, United States

How clear is this clinincal trial information?

Study is for people with:

Prostate Cancer

Phase:

Phase 3

Estimated Enrollment:

348

Study ID:

NCT00244309

Recruitment Status:

Completed

Sponsor:


Case Comprehensive Cancer Center

How clear is this clinincal trial information?

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