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
|