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Comparing 0.5 mg Dutasteride vs Placebo Daily in Men Receiving Androgen Ablation Therapy for Prostate Cancer

NCT00553878 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2016-10-14

No results posted yet for this study

Summary

Patient on an intermittent androgen deprivation protocol for biochemical recurrence after radical local therapy for prostate cancer,the addition of continuous dutasteride treatment, significantly prolongs the duration of the off treatment interval and time to androgen independence.

Conditions

Interventions

DRUG

Dutasteride

dutasteride 0.5mg capsule daily until serum PSA rises to 5ng/ml in the off treatment interval

Sponsors & Collaborators

  • GlaxoSmithKline

    collaborator INDUSTRY

  • Canadian Urology Research Consortium

    lead OTHER

Principal Investigators

  • Laurence Klotz, MD · CURC

  • Larry S Goldeng · CUOG

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
SINGLE_GROUP

Eligibility

Min Age
45 Years
Max Age
80 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-03-31
Primary Completion
2009-09-30
Completion
2012-12-31

Countries

  • Canada

Study Locations

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Entities

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 NCT00553878 on ClinicalTrials.gov