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3 Month Finasteride Challenge Test Can Significantly Improve the Performance of Screening for Prostate Cancer

Information source: The University of Texas Health Science Center at San Antonio
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Prostate Cancer

Intervention: Finasteride (Drug)

Phase: Phase 4

Status: Recruiting

Sponsored by: The University of Texas Health Science Center at San Antonio

Official(s) and/or principal investigator(s):
Javier Hernandez, MD, Principal Investigator, Affiliation: The University of Texas Health Science Center at San Antonio

Overall contact:
Joseph Long, Phone: (210) 450-0754, Email: longj4@uthscsa.edu

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.

Clinical Details

Official title: Improving Prostate Biopsy Efficiency: The Finasteride Challenge Test

Study design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Screening

Primary outcome: Determine if finasteride improves the Prostate Specific Antigen (PSA) and the Digital Rectal Exam (DRE) for prostate cancer screening by reducing the PSA and the size of the prostate.

Detailed description: 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

Minimum age: 55 Years. Maximum age: N/A. Gender(s): Male.

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.

Locations and Contacts

Joseph Long, Phone: (210) 450-0754, Email: longj4@uthscsa.edu

The University of Texas Health Science Center at San Antonio, Medical Arts and Research Center, San Antonio, Texas 78229, United States; Recruiting
Joseph Long, Phone: 210-450-0754, Email: longj4@uthscsa.edu
Javier Hernandez, MD, Principal Investigator
Additional Information

Starting date: February 2011
Last updated: March 19, 2015

Page last updated: August 23, 2015

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