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Improving Prostate Biopsy Efficiency: The Finasteride Challenge Test


Phase 4
55 Years
N/A
Open (Enrolling)
Male
Prostate Cancer

Thank you

Trial Information

Improving Prostate Biopsy Efficiency: The Finasteride Challenge Test


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.


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.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

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.

Outcome Description:

Participants will take Finasteride/Placebo 5mg per day by mouth for 3 months before prostate biopsy.

Outcome Time Frame:

3 months

Safety Issue:

No

Principal Investigator

Javier Hernandez, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

The University of Texas Health Science Center at San Antonio

Authority:

United States: Institutional Review Board

Study ID:

ROI10-352

NCT ID:

NCT01296672

Start Date:

February 2011

Completion Date:

September 2015

Related Keywords:

  • Prostate Cancer
  • Finasteride
  • Placebo
  • Prostate cancer
  • Prostate Specific Antigen (PSA)
  • Men at intermediate risk of prostate cancer
  • Men scheduled for prostate biopsy
  • Prostatic Neoplasms

Name

Location
The University of Texas Health Science Center at San Antonio, Medical Arts and Research Center San Antonio, Texas  78229