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Completed

NCT Number: NCT01296672

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

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.

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Key information

Conditions

Prostate Cancer Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

55 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Phase 4

Primary location

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

San Antonio, Texas, 78229, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.)

Exclusion criteria

  • 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.

Treatment and study plan

finasteride

Drug

Finasteride 5mg every day by mouth for 3 months

Other names: Proscar®, Propecia®

Placebo

Drug

Placebo every day by mouth for 3 months

Primary outcomes

  1. Pre/Post Ratio PSA Area Under the Curve (AUC)

    Time frame: 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 outcomes

  1. PCA3 (Prostate Cancer Antigen 3)Score AUC

    Time frame: 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)

  2. T2:ERG ( A Gene on Chromosome 21q22.2 That Encodes an Androgen-regulated Transmembrane Serine Protease Ratio to Estrogen Related Gene) Score AUC

    Time frame: 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

Sponsors and collaborators

Lead sponsor

The University of Texas Health Science Center at San Antonio

Other

Collaborators

  • National Cancer Institute (NCI)
  • National Institutes of Health (NIH)

Registry information

Official study title

Improving Prostate Biopsy Efficiency: The Finasteride Challenge Test

Important dates

Study start
2011
Primary completion
2016
Study completion
2017
First posted
Feb 15, 2011
Registry last updated
Oct 6, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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