Phase 4
N=383
3 Month Finasteride Challenge Test Can Significantly Improve the Performance of Screening for Prostate Cancer
Prostate Cancer
Bottom Line
View on ClinicalTrials.gov: NCT01296672 ↗Enrolled (actual)
383
Serious AEs
1.0%
Results posted
Sep 2017
Primary outcome: Primary: Pre/Post Ratio PSA Area Under the Curve (AUC) — 0.57; 0.61 Ratio
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Finasteride (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 55+ yrs
- Sex
- Male
- Sponsor
- The University of Texas Health Science Center at San Antonio
- Primary completion
- Nov 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Pre/Post Ratio PSA Area Under the Curve (AUC) |
0.57; 0.61 | — |
| SECONDARY PCA3 (Prostate Cancer Antigen 3)Score AUC |
0.65; 0.84 | — |
| SECONDARY T2:ERG ( A Gene on Chromosome 21q22.2 That Encodes an Androgen-regulated Transmembrane Serine Protease Ratio to Estrogen Related Gene) Score AUC |
0.62; 0.62 | — |
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT01296672). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.