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

NCT01296672 | Completed Phase 4 Results

• 2 other identifiers: ROI 10-352HR01CA138627
• Study Type: interventional
• Target: 383
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostate Cancer

Keywords

Finasteride; Placebo; Prostate cancer; Prostate Specific Antigen (PSA); Men at intermediate risk of prostate cancer; Men scheduled for prostate biopsy

Outcome Measures

Primary Outcomes (1)

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

  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.

  Reported at 90-days: assessment at baseline, 1 month, 2 months and 3 months

Secondary Outcomes (2)

• PCA3 (Prostate Cancer Antigen 3)Score AUC

  Reported at 90 days: assessed at baseline, 30 days, 60 days and 90-day

• 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

Study Arms (2)

Finasteride

EXPERIMENTAL

Finasteride 5mg tablets every day by mouth for 3 months

Drug: Finasteride

Placebo

PLACEBO COMPARATOR

Placebo 5mg tablet every day by mouth for 3 months

Drug: Placebo

Interventions

Finasteride DRUG

Finasteride 5mg every day by mouth for 3 months

Also known as: Proscar®, Propecia®

Finasteride

Placebo DRUG

Placebo every day by mouth for 3 months

Placebo

Eligibility Criteria

• Age: 55 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.)

You may not qualify if:

• 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.

Sponsors & Collaborators

• The University of Texas Health Science Center at San Antonio: lead
• National Institutes of Health (NIH): collaborator
• National Cancer Institute (NCI): collaborator

Study Sites (1)

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

San Antonio, Texas, 78229, United States

Location

Related Publications (1)

• Hernandez J, Gelfond J, Goros M, Liss MA, Liang Y, Ankerst D, Thompson IM Jr, Leach RJ. The effect of 3-month finasteride challenge on biomarkers for predicting cancer outcome on biopsy: Results of a randomized trial. PLoS One. 2018 Oct 9;13(10):e0204823. doi: 10.1371/journal.pone.0204823. eCollection 2018.

  PMID: 30300367 DERIVED

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Finasteride

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Androstenes; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Azasteroids; Steroids, Heterocyclic

Results Point of Contact

• Title: Jonathan Gelfond
• Organization: UT Health

gelfondjal@uthscsa.edu

210 567-0836

Study Officials

• Javier Hernandez, MD

  The University of Texas Health Science Center at San Antonio

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 3, 2011
• First Posted: February 15, 2011
• Study Start: February 1, 2011
• Primary Completion: November 1, 2016
• Study Completion: January 1, 2017
• Last Updated: October 6, 2017
• Results First Posted: September 8, 2017

Record last verified: 2017-03

Locations

US (1)