Long-term Effects of Dutasteride on Architectural and Nuclear Morphometric Features of Benign Prostate Tissue

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01473030

Enrollment

Registered

2011-11-17

Start date

2011-11-30

Completion date

2018-12-31

Last updated

2020-10-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Benign Prostate Tissue

Keywords

Benign prostate, serum DHT, Dutasteride, PSA, Avodart

Brief summary

The overall goal of this project is to quantify the long-term effects of dutasteride on the architectural and nuclear features of benign prostate tissue, using state-of-the art digital image analysis techniques. The ultimate result will be a multivariable morphological signature that could provide a useful indicator of an individual's degree of drug response.

Interventions

None listed

Study design

Observational model

CASE_CONTROL

Time perspective

CROSS_SECTIONAL

Eligibility

Sex/Gender

MALE

Age

50 Years to 75 Years

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 * subgroup: Year 2 biopsy blocks and HE slides available for Aim 4a

Exclusion criteria

* N/A

Design outcomes

Primary

Measure	Time frame	Description
Architectural Features	Year 4	To characterize and quantify the effects of dutasteride on histological (architectural) features of benign prostate tissue via comparison of a random sample of Year 4 biopsy specimens from the dutasteride and placebo groups.
Morphometric features	Year 4	To quantify the long-term (Year 4) effects of dutasteride on nuclear morphometric features (i.e., size, shape and texture) in benign prostatic epithelial cells. To develop and validate a multivariable morphological score based on summarization of differences between drug- and placebo-treated tissues.
Independent changes in architecture and morphometry	Year 4	To determine the degree to which drug-related changes at Year 4 in architectural and nuclear features are independent of (i.e., not explained by) changes in serum DHT, gland volume and PSA.

Secondary

Measure	Time frame	Description
Changes in cytomorphology	Year 2 & Year 4	To determine, by comparing Year 2 to Year 4 samples within individuals, whether drug-related cytomorphological changes are constant, declining or progressing.

Countries

United States

Outcome results