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

Alternate Title

Phase II Randomized Study of Dietary Soy in Patients With Elevated PSA Levels

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II	Prevention	Completed	50 and over	NCI	CALGB-79806 NCI-P02-0207, NCT00031746

Trial Description

Purpose:

Soy protein supplement may prevent or delay the development of prostate cancer in patients who have elevated prostate-specific antigen (PSA) levels.

Randomized phase II trial to determine the effectiveness of soy protein supplement in preventing prostate cancer in patients who have elevated PSA levels.

Eligibility:

Eligibility criteria include the following:

• At least 50 years old
• No previous hormone therapy
• At least 6 months since transurethral resection of the prostate
• No previous surgery to remove the testicles
• 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:

All patients will receive a placebo by mouth once a day for 2 weeks. Patients will then be randomly assigned to one of two groups. Patients in group one will receive soy protein supplement by mouth once a day for up to 1 year. Patients in group two will receive a placebo as in group one. Quality of life will be assessed periodically.

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

James Mohler, MD, Protocol chair		Ph: 716-845-3389; 800-685-6825

Registry Information
Official Title		Effects of Dietary Soy on Biomarkers of Prostate Cancer: A Prospective Phase II Study
Trial Start Date		2000-02-15
Trial Completion Date		2008-02-19
Registered in ClinicalTrials.gov		NCT00031746
Date Submitted to PDQ		2002-01-03
Information Last Verified		2006-07-31
NCI Grant/Contract Number		CA76001

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