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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 Pilot Study of Calcitriol and Dexamethasone Before Radical Prostatectomy in Patients With Localized Adenocarcinoma of the Prostate

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II	Treatment	Closed	18 and over	NCI	RPCI-RP-0212 NCT00084864

Trial Description

Purpose:

Calcitriol and dexamethasone may slow the growth of prostate cancer cells.

This randomized phase II trial is studying how well giving calcitriol together with dexamethasone before radical prostatectomy works in treating patients with localized stage II or stage III adenocarcinoma (cancer) of the prostate.

Eligibility:

Eligibility criteria include the following:

• At least 18 years old
• Scheduled to undergo radical prostatectomy
• More than 5 years since hormone therapy
• No previous kidney or prostate surgery
• No previous cryotherapy or transurethral resection of the prostate
• 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:

Some patients will be randomly assigned to one of two groups.

• Patients in group one will receive dexamethasone by mouth once a day on days 1-4 and calcitriol by mouth once a day on days 2-4 of each week for 4 weeks. Within 2 days, they will undergo surgery.
• Patients in group two will undergo surgery.

Other patients will be randomly assigned to one of four groups.

• Patients in group one will receive dexamethasone by mouth once a day on days 1-4 and calcitriol by mouth once a day on days 2-4 of each week for 4 weeks. Within 2 days, they will undergo surgery.
• Patients in group two will receive dexamethasone by mouth once a day on days 1-4. Within 2 days, they will undergo surgery.
• Patients in group three will receive calcitriol once a day on days 2-4. Within 2 days, they will undergo surgery.
• Patients in group four will undergo surgery.

All patients will be evaluated at 1, 3, and 12 months.

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

Roswell Park Cancer Institute

Donald Trump, MD, Principal investigator		Ph: 716-845-3499; 800-685-6825 Email: donald.trump@roswellpark.org

Registry Information
Official Title		A Pilot Trial of Calcitriol in Localized Prostate Cancer: Investigation of Biologic Effects and Potential Intermediate Endpoints
Trial Start Date		2002-09-19
Trial Completion Date		2011-12-20 (estimated)
Registered in ClinicalTrials.gov		NCT00084864
Date Submitted to PDQ		2004-04-12
Information Last Verified		2008-11-30
NCI Grant/Contract Number		CA16056

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