Clinical trial · Interventional
3 Month Finasteride Challenge Test Can Significantly Improve the Performance of Screening for Prostate Cancer
Improving Prostate Biopsy Efficiency: The Finasteride Challenge Test
NCT01296672CI-TRIAL-00029800completedPhase 4Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Finasteride | Drug | — | UNRESOLVED |
| Placebo | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Finasteride
- description
- Finasteride 5mg tablets every day by mouth for 3 months
- interventionNames
- Drug: Finasteride
- type
- PLACEBO_COMPARATOR
- label
- Placebo
- description
- Placebo 5mg tablet every day by mouth for 3 months
- interventionNames
- Drug: Placebo
Primary outcomes (1)
- measure
- Pre/Post Ratio PSA Area Under the Curve (AUC)
- timeFrame
- Reported at 90-days: assessment at baseline, 1 month, 2 months and 3 months
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 55 Years
Show eligibility criteria text
Inclusion Criteria: 1. 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 2. Patient has been recommended to undergo and plans to have a prostate biopsy. 3. Patient is willing to delay prostate biopsy for a 3-month finasteride vs placebo treatment. 4. No allergy to finasteride or other five alpha reductase inhibitors. 5. Patient is willing to take finasteride vs placebo 5 mg orally daily for 3-month treatment period. 6. Age 55 or older. (This age is selected as the PCPT risk calculator is only valid for this age range.) Exclusion Criteria: 1. Risk of cancer greater than 60% or less than 20%. 2. Prior history of prostate cancer. 3. Prior treatment with finasteride or dutasteride in the past 6 months 4. Younger than age 55.
References
Publications (1)
- DERIVEDHernandez 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