Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Prostatic Neoplasms

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

Urological Agents

All Drugs and Chemicals

Finasteride

5-alpha Reductase Inhibitors

Enzyme Inhibitors

Hormones

Hormone Antagonists

Finasteride 5mg tablets every day by mouth for 3 months

Placebo 5mg tablet every day by mouth for 3 months

Finasteride 5mg every day by mouth for 3 months

Placebo

Javier Hernandez, MD

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.

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.

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

Improving Prostate Biopsy Efficiency: The Finasteride Challenge Test

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.

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)

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

National Institutes of Health (NIH)

National Cancer Institute (NCI)

The University of Texas Health Science Center at San Antonio

Finasteride 5mg tablets every day by mouth for 3 months

Finasteride: Finasteride 5mg every day by mouth for 3 months

Placebo 5mg tablet every day by mouth for 3 months

Placebo: Placebo every day by mouth for 3 months

Spots Global Cancer Trial Database for men at intermediate risk of prostate cancer