3 Month Finasteride Challenge Test Can Significantly Improve the Performance of Screening for Prostate Cancer
- Registration Number
- NCT01296672
- Brief 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.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 383
- 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
- Patient has been recommended to undergo and plans to have a prostate biopsy.
- Patient is willing to delay prostate biopsy for a 3-month finasteride vs placebo treatment.
- No allergy to finasteride or other five alpha reductase inhibitors.
- Patient is willing to take finasteride vs placebo 5 mg orally daily for 3-month treatment period.
- Age 55 or older. (This age is selected as the PCPT risk calculator is only valid for this age range.)
- Risk of cancer greater than 60% or less than 20%.
- Prior history of prostate cancer.
- Prior treatment with finasteride or dutasteride in the past 6 months
- Younger than age 55.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo Placebo 5mg tablet every day by mouth for 3 months Finasteride Finasteride Finasteride 5mg tablets every day by mouth for 3 months
- Primary Outcome Measures
Name Time Method Pre/Post Ratio PSA Area Under the Curve (AUC) Reported at 90-days: assessment at baseline, 1 month, 2 months and 3 months Pre/Post Ratio prediction area under the receiver operating characteristics curve (AUC) for subjects taking finasteride 5mg every day for 3 months. Measurements of PSA are measured from Baseline until 3 months.
- Secondary Outcome Measures
Name Time Method PCA3 (Prostate Cancer Antigen 3)Score AUC Reported at 90 days: assessed at baseline, 30 days, 60 days and 90-day Area under the Receiver Operating Characteristic Curve (ROC-AUC) of the PCA3 (Prostate Cancer Antigen 3) to detect difference in PSA decline between cases and controls (non-cases)
T2:ERG ( A Gene on Chromosome 21q22.2 That Encodes an Androgen-regulated Transmembrane Serine Protease Ratio to Estrogen Related Gene) Score AUC Reported at 90 days: assessed at baseline, 30 days, 60 days, and 90 days Area Under the Receiver Operating Characteristic Curve (ROC-AUC) of the T2:ERG ( A Gene on Chromosome 21q22.2 That Encodes an Androgen-regulated Transmembrane Serine Protease Ratio to Estrogen Related Gene) Score to Predict the Risk of Prostate Cancer
Trial Locations
- Locations (1)
The University of Texas Health Science Center at San Antonio, Medical Arts and Research Center
🇺🇸San Antonio, Texas, United States