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

Case Comprehensive Cancer Center (Case CCC)

Status and phase

Completed

Phase 3

Conditions

Prostate Cancer

Treatments

Drug: tamsulosin and/or dutasteride

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT00244309

GSK106046 (formerly 103988)

CASE14804

Details and patient eligibility

About

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.

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.

Enrollment

348 estimated patients

Sex

Male

Ages

18+ years old

Volunteers

No Healthy Volunteers

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