Validation of Digital Morphometry for Cancer Risk in Benign Prostate Biopsies

University of Illinois

Status: Completed

Conditions: Prostate Cancer

Treatments: Drug: Dutasteride; Drug: Placebo

Study type: Observational

Funder types: Other; NIH

Identifiers

NCT01594502

R01CA155301 (U.S. NIH Grant/Contract)

2010-0670

Details and patient eligibility

About

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.

Enrollment: 139 patients

Sex: Male

Ages: 50 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

139 participants in 6 patient groups

Dutasteride Year 2 PCa

Description:

Subject assigned to dutasteride, prostate cancer found on Year 2 biopsy.

Treatment:

Drug: Dutasteride

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.

Treatment:

Drug: Placebo

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.

Treatment:

Drug: Dutasteride

Placebo, Year 2 and 4 no PCa

Description:

Subject assigned to placebo, no prostate cancer found on Year 2 or Year 4 biopsy.

Treatment:

Drug: Placebo

Dutasteride, Year 2 and 4 no PCa

Description:

Subject assigned to dutasteride, no prostate cancer found on Year 2 or Year 4 biopsy.

Treatment:

Drug: Dutasteride

Placebo, Year 2 PCa

Description:

Subject assigned to placebo, prostate cancer found on Year 2 biopsy.

Treatment:

Drug: Placebo