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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 Early Medical Adrenalectomy Using Hydrocortisone Combined With Aminoglutethimide or Ketoconazole in Patients With Localized Stage IV (D0.5) Adenocarcinoma of the Prostate

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II	Treatment	Completed	Not specified	NCI	MCC-12219 MCC-IRB-5722, NCI-G00-1863, NCT00006371

Trial Description

Purpose:

Androgens can stimulate the growth of prostate cancer cells. Drugs such as aminoglutethimide or ketoconazole may stop the adrenal glands from producing hormones. Combining hydrocortisone with either aminoglutethimide or ketoconazole may be an effective treatment for prostate cancer.

Phase II trial to study the effectiveness of combining hydrocortisone with either aminoglutethimide or ketoconazole in treating patients who have localized stage IV prostate cancer.

Eligibility:

• More than 4 weeks since flutamide
• No previous aminoglutethimide or ketoconazole 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 hydrocortisone combined with either aminoglutethimide or ketoconazole. Hydrocortisone will be given by mouth twice a day. Aminoglutethimide will be given by mouth twice a day for 1 week and then four times a day for all subsequent weeks. Ketoconazole will be given by mouth three times a day. Treatment may continue for as long as benefit is shown.

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

H. Lee Moffitt Cancer Center and Research Institute at University of South Florida

Mayer Fishman, MD, PhD, Protocol chair		Ph: 813-745-8311; 888-663-3488 Email: mayer.fishman@moffitt.org

Registry Information
Official Title		A Phase II Trial of Early Medical Adrenalectomy for "D0.5" Prostate Cancer
Trial Start Date		2000-05-16
Trial Completion Date		2002-12-31
Registered in ClinicalTrials.gov		NCT00006371
Date Submitted to PDQ		2000-08-25
Information Last Verified		2009-07-06
NCI Grant/Contract Number		CA76292

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