NCT00055731

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

Phase III Randomized Study Of Adjuvant Hormonal Therapy With And Without Docetaxel And Estramustine In Patients With Advanced Prostate Cancer Or With A High Risk Of Relapse

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 413 (actual)
• Sponsor: UNICANCER · Academic / Other
• Sex: Male
• Age: 0 Years – 79 Years
• Healthy volunteers: Not accepted

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

• Prostate Cancer

Interventions

Type	Name	Description
DRUG	bicalutamide
DRUG	Goserelin Acetate
DRUG	docetaxel
DRUG	Estramustine phosphate sodium
DRUG	acetylsalicylic acid
PROCEDURE	conventional surgery
RADIATION	radiation therapy

Timeline

• Start date: 2002-11-14
• Primary completion: 2010-12-21
• Completion: 2022-12-31
• First posted: 2003-03-07
• Last updated: 2023-01-18

Locations

38 sites across 1 country: France