Basic Trial Information
Trial Description
     Summary
     Further Trial Information
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

Trial Description

Summary

The investigators will propose a novel method to improve prostate cancer screening with PSA, using a 3-month treatment with finasteride, a drug used to treat Benign Prostatic Hyperplasia (BPH) and proven to reduce a man's risk of developing prostate cancer. The investigators will also examine three additional promising tests that may further improve diagnosis of prostate cancer.

Further Study Information

The primary goal of this proposal is to determine if a 5-alpha reductase 'challenge' improves screening performance of PSA and DRE in men who are scheduled for prostate biopsy. Currently a higher PSA level leads to a recommendation for prostate biopsy, causing hundreds of thousands of unnecessary biopsies annually in the U.S. We will show that a three-month treatment with finasteride for men with high PSA levels will better predict the man who should have a prostate biopsy. PSA performance after finasteride 'challenge' will also be compared with new tests for prostate cancer. Finasteride is supplied by Merck and Company, Incorporated.

Eligibility Criteria

Inclusion Criteria:

1. Risk of prostate cancer 20-60% calculated with the on-line Prostate Cancer Prevention Trial (PCPT) prostate cancer risk calculator. (www.prostate-cancer-risk-calculator.com). PSA value must be obtained within 3 months prior to study entry. A description of the frequency of these individuals in the population is provided in Specific Aim 2

2. Patient has been recommended to undergo and plans to have a prostate biopsy.

3. Patient is willing to delay prostate biopsy for a 3-month finasteride vs placebo treatment.

4. No allergy to finasteride or other five alpha reductase inhibitors.

5. Patient is willing to take finasteride vs placebo 5 mg orally daily for 3-month treatment period.

6. Age 55 or older. (This age is selected as the PCPT risk calculator is only valid for this age range.)

Exclusion Criteria:

1. Risk of cancer greater than 60% or less than 20%.

2. Prior history of prostate cancer.

3. Prior treatment with finasteride or dutasteride in the past 6 months

4. Younger than age 55.

Trial Contact Information

Trial Lead Organizations/Sponsors

University of Texas Health Science Center at San Antonio

Ian Murchie Thompson

Principal Investigator

Esther Nanez, RN		Ph: 210-567-1995
		Email: nanez@uthscsa.edu

U.S.A.
Texas
	San Antonio
	University of Texas Health Science Center at San Antonio
		Esther Nanez, RN	Ph: 210-567-1995
			Email: nanez@uthscsa.edu
		Linda Hernandez, RN	Ph: 210-450-0016
			Email: hernandezmh@uthscsa.edu
		Ian Murchie Thompson	Principal Investigator

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT01296672
Information obtained from ClinicalTrials.gov on January 23, 2013

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