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Prostate Cancer Study In Men Who Have Failed First-Line Androgen Deprivation Therapy

NCT00470834 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 127

Last updated 2017-02-27

Study results available
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Summary

Dutasteride inhibits the conversion of testosterone to dihydrotestosterone (DHT) the male hormone that leads to benign prostate growth. By blocking the conversion of testosterone to DHT, dutasteride could allow bicalutamide to be a more effective anti-androgen thus prolonging bicalutamide's efficacy.

Conditions

  • Neoplasms, Prostate

Interventions

DRUG

dutasteride

0.5mg dutasteride (Investigation Product)

DRUG

placebo

making placebo

DRUG

bicalutamide

50 mg Casodex or generic equivalent

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2007-05-31
Primary Completion
2013-02-28
Completion
2013-02-28

Countries

  • United States
  • Canada

Study Locations

More Related Trials

Entities

Drugs
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 NCT00470834 on ClinicalTrials.gov