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Hormone Therapy With or Without Docetaxel And Estramustine in Treating Patients With Prostate Cancer That is Locally Advanced or At High Risk of Relapse

NCT00055731 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 413

Last updated 2023-01-18

No results posted yet for this study

Summary

RATIONALE: Androgens can stimulate the growth of prostate cancer cells. Drugs such as nilutamide, bicalutamide, flutamide, or cyproterone may stop the adrenal glands from producing androgens. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known whether hormone therapy is more effective with or without chemotherapy in treating prostate cancer.

PURPOSE: Randomized phase III trial to compare the effectiveness of hormone therapy with or without docetaxel and estramustine in treating patients who have prostate cancer that is locally advanced or at high risk of relapse.

Conditions

Interventions

DRUG

bicalutamide

DRUG

Goserelin Acetate

DRUG

docetaxel

DRUG

Estramustine phosphate sodium

DRUG

acetylsalicylic acid

PROCEDURE

conventional surgery

RADIATION

radiation therapy

Sponsors & Collaborators

  • Sanofi

    collaborator INDUSTRY

  • AstraZeneca

    collaborator INDUSTRY

  • UNICANCER

    lead OTHER

Principal Investigators

  • Karim Fizazi, MD, PhD · Gustave Roussy, Cancer Campus, Grand Paris

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
0 Years
Max Age
79 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2002-11-14
Primary Completion
2010-12-21
Completion
2022-12-31

Countries

  • France

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 NCT00055731 on ClinicalTrials.gov