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A Study of Androgen Deprivation With Leuprolide, +/- Docetaxel for Clinically Asymptomatic Prostate Cancer Participants With a Rising Prostate Specific Antigen (PSA)

NCT00514917 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 413

Last updated 2013-11-04

Study results available
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Summary

The primary objective was to evaluate and compare the efficacy of androgen deprivation with or without docetaxel as determined by the median progression free survival (PFS) over the period of 18-month therapy and at least 18-month follow-up.

The secondary objectives were:

* To assess cancer specific survival;
* To compare overall survival between the 2 treatment groups;
* To evaluate patient-reported outcomes including quality of life, fatigue, and sexual functioning as measured by 3 different assessments.

Conditions

  • Prostatic Neoplasms

Interventions

DRUG

Docetaxel

75 mg/m\^2 intravenous infusion over 1 hour every 3 weeks up to 10 cycles.

DRUG

Leuprolide

22.5 mg injection subcutaneously every 12 weeks up to 18 months.

DRUG

Bicalutamide

50 mg tablet orally once daily for first 4 weeks of treatment.

Sponsors & Collaborators

Principal Investigators

  • Barrett Childs, MD · Sanofi

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-07-31
Primary Completion
2012-09-30
Completion
2012-09-30

Countries

  • United States
  • Belgium
  • Canada
  • Czechia
  • Germany
  • Lithuania
  • Poland
  • Slovakia
  • Spain

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 NCT00514917 on ClinicalTrials.gov