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Study Assessing The Efficacy And Safety Of Avodart (Dutasteride) At Improving Urinary Symptoms In Men With Prostate Cancer Who Are Undergoing Seed Implantation

NCT00805701 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2014-05-14

No results posted yet for this study

Summary

Avodart (dutasteride) reduces the male hormone (DHT) that leads to prostate growth and stimulates cancerous growth. Avodart is currently approved by the FDA to treat men with symptoms of an enlarged prostate. Avodart works by reducing DHT and prostate size; therefore, the drug may be useful in improving lower urinary tract symptoms (LUTS) such as frequency, urgency, weak stream, and urination difficulty (dysuria), among others, in men with prostate cancer. Avodart may be effective in men with prostate cancer who are being treated with hormonal therapy with one injection of Zolodex (goserelin) followed one month later with a trans-urethral incision of the prostate (TUIP), and three months after that, seed implantation (SI) of the prostate.

The purpose of this study is to test whether Avodart (dutasteride) is effective on LUTS and dysuria in men with localized prostate cancer being treated with single-dose goserelin, TUIP, and interval SI.

Conditions

Interventions

DRUG

avodart

0.5 avodart once daily for 13 weeks

DRUG

Placebo

placebo

Sponsors & Collaborators

  • GlaxoSmithKline

    collaborator INDUSTRY

  • Bay State Clinical Trials, Inc.

    lead OTHER

Principal Investigators

  • Henry D Mitcheson, MD · Bay State Clinical Trials, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
SINGLE_GROUP

Eligibility

Min Age
35 Years
Max Age
90 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-01-31
Primary Completion
2014-04-30
Completion
2014-04-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00805701 on ClinicalTrials.gov