Clinical trial · Observational
Validation of Digital Morphometry for Cancer Risk in Benign Prostate Biopsies
R01 CA155301: Validation of Digital Morphometry for Cancer Risk in Benign Prostate Biopsies
NCT01594502CI-TRIAL-00047626completedClinicalTrials.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 goal of this study is to apply cutting-edge imaging approaches, incorporating machine-learning for pattern recognition and multispectral analysis, to the development and validation of intermediate endpoint biomarkers in benign tissue that characterize the response to 5α-reductase inhibitor chemoprevention as well as the risk of prostate cancer among men with negative biopsies.
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 |
|---|---|---|---|
| Dutasteride | Drug | — | UNRESOLVED |
| Placebo | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (6)
- label
- Dutasteride Year 2 PCa
- description
- Subject assigned to dutasteride, prostate cancer found on Year 2 biopsy.
- interventionNames
- Drug: Dutasteride
- label
- Placebo Year 2 no PCa, Year 4 PCa
- description
- Subject assigned to placebo, no prostate cancer found on Year 2 biopsy, but prostate cancer found on Year 4 biopsy.
- interventionNames
- Drug: Placebo
- label
- Dutasteride Year 2 no PCa, Year 4 PCa
- description
- Subject assigned to dutasteride, no prostate cancer found on Year 2 biopsy, but prostate cancer found on Year 4 biopsy.
- interventionNames
- Drug: Dutasteride
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 50 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * completed REDUCE trial (Year 4 exit biopsy with blocks and HE slides available; i.e., U.S. participants only) * compliant with assigned treatment based on either: (dutasteride group) at least 3 post-baseline serum DHT levels ≥ 50% lower than baseline, or (placebo group) at least 3 post-baseline serum DHT levels with none showing ≥ 50% decrease from baseline Exclusion Criteria: * N/A
References
Publications (0)
Data not yet available
No reference posted for this study.