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Alternate Title
Basic Trial Information
Trial Description
     Purpose
     Eligibility
     Treatment/Intervention
Trial Contact Information
Registry Information

Alternate Title

Phase III Randomized Study of Neoadjuvant Releasing Factor Agonist Therapy and Antiandrogen Therapy With or Without Docetaxel And Estramustine in Patients With Locally Advanced Prostate Cancer or With A High Risk of Relapse

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase III	Treatment	Closed	Under 80	Other	FRE-FNCLCC-GETUG-12/0203 EU-20238, NCT00055731

Trial Description

Purpose:

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.

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.

Eligibility:

Eligibility criteria include the following:

• Younger than 80 years old
• No metastatic cancer
• Have undergone previous surgery to remove lymph nodes
• No previous chemotherapy or hormone therapy
• For more information about the eligibility criteria for this trial, refer to the Health Professional version.

Final eligibility for a clinical trial is determined by the health professionals conducting the trial.

Treatment/Intervention:

Patients will be randomly assigned to one of two groups.

Patients in group one will receive either nilutamide by mouth twice a day, bicalutamide once a day, flutamide three times a day, or cyproterone four times a day. They will also receive a 1-hour infusion of docetaxel on day 2 and estramustine on days 1-5. Treatment may be repeated every 3 weeks for four courses. Patients will also receive either an injection of buserelin every 2 months or an injection of triptorelin, leuprolide, or goserelin every 3 months.

Patients in group two will receive treatment as in group one, but will not receive docetaxel and estramustine.

Beginning approximately 3 weeks after completing therapy, patients in both groups will undergo radiation therapy 5 days a week for 6-7 weeks, radical prostatectomy, or no further local therapy. Hormone therapy will continue in both groups for up to 3 years. Quality of life will be assessed at the beginning of the study, at 3 months, and at 1 year. Patients will be evaluated every 6 months for 5 years.

Important:

For more details about this trial, refer to the Health Professional version of the trial summary.

If you are interested in participating in a clinical trial, contact your doctor for a referral or call a trial contact person listed below. You may see the same contact person listed at more than one site, however, if you call the number listed you can ask to speak to the study coordinator or person involved with the specific trial you are interested in. If you have questions about cancer or clinical trials, call the Cancer Information Service at 1-800-4-CANCER (1-800-422-6237). General information about clinical trials, including risks, benefits, and costs, can be found on NCI's Web site.

Trial Contact Information

Trial Lead Organizations

Federation Nationale des Centres de Lutte Contre le Cancer

Karim Fizazi, MD, PhD, Protocol chair		Ph: 33-1-4211-6264 Email: fizazi@igr.fr

Registry Information
Official Title		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
Trial Start Date		2002-11-01
Registered in ClinicalTrials.gov		NCT00055731
Date Submitted to PDQ		2003-01-14
Information Last Verified		2008-04-27

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