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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 Radiotherapy With Or Without Bicalutamide in Patients With PSA Elevation Following Radical Prostatectomy for Carcinoma of the Prostate

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase III	Treatment	Completed	Any age	NCI	RTOG-9601 RTOG 96-01, RTOG-R9601, NCT00002874, RTOG-96-01

Special Category: CTSU trial

Trial Description

Purpose:

Radiation therapy uses high-energy x-rays to damage tumor cells. Androgens can stimulate the growth of prostate cancer cells. Hormone therapy using bicalutamide may fight prostate cancer by reducing the production of androgens. It is not yet known if radiation therapy is more effective with or without bicalutamide for prostate cancer.

Randomized phase III trial to compare the effectiveness of radiation therapy with or without bicalutamide in treating patients who have stage II, stage III, or recurrent prostate cancer and elevated PSA levels following radical prostatectomy.

Eligibility:

• Any age
• At least 4 months since prostatectomy
• PSA level of 0.2- 4.0
• No distant metastases
• No previous biological therapy, chemotherapy, or radiation therapy 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 be randomly assigned to one of two groups. Patients in group one will receive radiation therapy for 7.2 weeks plus bicalutamide by mouth daily for 2 years. Patients in group two will receive radiation therapy for 7.2 weeks plus a placebo by mouth daily for 2 years. Patients will receive follow-up evaluations every 3 months for 2 years, every 6 months for 3 years, and once a year thereafter.

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

Radiation Therapy Oncology Group

William Shipley, MD, FACR, Protocol chair		Ph: 617-726-8146; 877-726-5130 Email: wshipley@partners.org

Southwest Oncology Group

H. Grossman, MD, Protocol chair		Ph: 713-792-3250; 800-392-1611

Registry Information
Official Title		A PHASE III TRIAL OF RADIATION THERAPY WITH OR WITHOUT CASODEX IN PATIENTS WITH PSA ELEVATION FOLLOWING RADICAL PROSTATECTOMY FOR pT3N0 CARCINOMA OF THE PROSTATE
Trial Start Date		1998-02-15
Registered in ClinicalTrials.gov		NCT00002874
Date Submitted to PDQ		1996-01-10
Information Last Verified		2003-03-27
NCI Grant/Contract Number		CA21661

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