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

Alternate Title

Phase II Study of Androgen-Suppression Therapy Combined With External-Beam Radiotherapy and Boost Brachytherapy in Patients With Intermediate-Risk Localized Prostate Cancer

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II	Treatment	Closed	18 and over	NCI	CALGB-99809 NCT00006359

Trial Description

Purpose:

Androgens can cause the growth of prostate cancer cells. Drugs, such as leuprolide, goserelin, flutamide, or bicalutamide, may stop the adrenal glands from making androgens. Radiation therapy uses high-energy x-rays to damage tumor cells. Giving these drugs together with radiation therapy may kill more tumor cells.

This phase II trial is studying how well androgen suppression with either leuprolide or goserelin and either flutamide or bicalutamide together with radiation therapy works in treating patients with prostate cancer.

Eligibility:

Eligibility criteria include the following:

• At least 18 years old
• No metastatic cancer
• No previous biological therapy, chemotherapy, radiation therapy, or surgery for prostate cancer
• 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 receive injections of either leuprolide or goserelin every 12 weeks for 24 weeks. They will also receive either flutamide by mouth three times a day or bicalutamide by mouth once a day for 4 weeks. Patients will then undergo external-beam radiation 5 days a week for 5 weeks. Two to four weeks after completing this radiation therapy, patients will undergo implant radiation. Patients will be evaluated every 3 months for 2 years, and then every 6 months for 4 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

Cancer and Leukemia Group B

Mark Hurwitz, MD, Protocol chair		Ph: 617-732-7936; 800-638-6294 Email: mhurwitz@lroc.harvard.edu

Registry Information
Official Title		Phase II Trial of Androgen Suppression for 6 months Combined with External Beam Radiotherapy (EBRT) with Brachytherapy (BT) Boost for Intermediate Risk Prostate Cancer
Trial Start Date		2000-09-15
Registered in ClinicalTrials.gov		NCT00006359
Date Submitted to PDQ		2000-08-23
Information Last Verified		2005-11-21
NCI Grant/Contract Number		CA31946

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