3 Month Finasteride Challenge Test Can Significantly Improve the Performance of Screening for Prostate Cancer
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ClinicalTrials.gov Identifier: NCT01296672 |
Recruitment Status
:
Completed
First Posted
: February 15, 2011
Results First Posted
: September 8, 2017
Last Update Posted
: October 6, 2017
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Prostate Cancer | Drug: Finasteride Drug: Placebo | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 383 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Triple (Participant, Care Provider, Investigator) |
Primary Purpose: | Screening |
Official Title: | Improving Prostate Biopsy Efficiency: The Finasteride Challenge Test |
Study Start Date : | February 2011 |
Actual Primary Completion Date : | November 2016 |
Actual Study Completion Date : | January 2017 |

Arm | Intervention/treatment |
---|---|
Experimental: Finasteride
Finasteride 5mg tablets every day by mouth for 3 months
|
Drug: Finasteride
Finasteride 5mg every day by mouth for 3 months
Other Names:
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Placebo Comparator: Placebo
Placebo 5mg tablet every day by mouth for 3 months
|
Drug: Placebo
Placebo every day by mouth for 3 months
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- 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.
- 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)
- 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

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Ages Eligible for Study: | 55 Years and older (Adult, Senior) |
Sexes Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01296672
United States, Texas | |
The University of Texas Health Science Center at San Antonio, Medical Arts and Research Center | |
San Antonio, Texas, United States, 78229 |
Principal Investigator: | Javier Hernandez, MD | The University of Texas Health Science Center at San Antonio |
Responsible Party: | The University of Texas Health Science Center at San Antonio |
ClinicalTrials.gov Identifier: | NCT01296672 History of Changes |
Other Study ID Numbers: |
ROI 10-352H R01CA138627 ( U.S. NIH Grant/Contract ) |
First Posted: | February 15, 2011 Key Record Dates |
Results First Posted: | September 8, 2017 |
Last Update Posted: | October 6, 2017 |
Last Verified: | March 2017 |
Keywords provided by The University of Texas Health Science Center at San Antonio:
Finasteride Placebo Prostate cancer |
Prostate Specific Antigen (PSA) Men at intermediate risk of prostate cancer Men scheduled for prostate biopsy |
Additional relevant MeSH terms:
Prostatic Neoplasms Genital Neoplasms, Male Urogenital Neoplasms Neoplasms by Site Neoplasms Genital Diseases, Male Prostatic Diseases Finasteride |
5-alpha Reductase Inhibitors Steroid Synthesis Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Urological Agents |