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R01 CA155301: Validation of Digital Morphometry for Cancer Risk in Benign Prostate Biopsies


N/A
50 Years
75 Years
Open (Enrolling)
Male
Prostate Cancer

Thank you

Trial Information

R01 CA155301: Validation of Digital Morphometry for Cancer Risk in Benign Prostate Biopsies


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

Type of Study:

Observational

Study Design:

Observational Model: Case Control, Time Perspective: Cross-Sectional

Outcome Measure:

Effects of dutasteride (vs. placebo) using multi-feature scores derived from digital image analysis on both nuclear and architectural features in benign prostate tissue.

Outcome Time Frame:

Year 4

Safety Issue:

No

Principal Investigator

Peter H Gann, MD, ScD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Illinois

Authority:

United States: Institutional Review Board

Study ID:

2010-0670

NCT ID:

NCT01594502

Start Date:

September 2011

Completion Date:

July 2021

Related Keywords:

  • Prostate Cancer
  • prostate cancer
  • dutasteride
  • Prostatic Neoplasms

Name

Location

University of Illinois at ChicagoChicago, Illinois  60612