Baseline subject characteristics predictive of compliance with study-mandated prostate biopsy in men at risk of prostate cancer: results from REDUCE.

Journal Article

Background

Study compliance is crucial when the study outcome is determined by an invasive procedure, such as prostate biopsy. To investigate predictors of compliance in study-mandated prostate biopsies, we analyzed demographic, clinical and reported lifestyle data from the REDUCE trial.

Methods

We retrospectively identified 8025 men from REDUCE with at least 2 years of follow-up, and used multivariable logistic regression to test the association between baseline demographic and clinical characteristics and undergoing the study-mandated prostate biopsy at 2 years. We then examined whether missing any of these data was associated with undergoing a biopsy.

Results

In REDUCE, 22% of men did not undergo a 2-year biopsy. On multivariable analysis, the non-North American region was predictive of 42-44% increased likelihood of undergoing a 2-year biopsy (P⩽0.001). Being enrolled at a center that enrolled >10 subjects (2nd and 3rd tertile) was associated with a 42-48% increased likelihood of undergoing a 2-year biopsy (P<0.001). In addition, black race predicted 44% lower rate of on-study 2-year biopsy (odds ratio (OR)=0.56; P=0.001). Finally, missing one or more baseline variables was associated with a 32% decreased likelihood of undergoing a 2-year biopsy (OR=0.68; P<0.001).

Conclusions

In REDUCE, men outside North America, those at higher volume centers and those with complete baseline data were more likely to undergo study-mandated 2-year biopsies. Given prostate biopsy is becoming increasingly utilized as an endpoint in trials that are often multi-national, regional differences in compliance should be considered when designing future trials. Likewise, efforts are needed to ensure compliance in low-volume centers or among subjects missing baseline data.

Full Text

Duke Authors

Cited Authors

  • Fischer, S; Sun, S; Howard, LE; Moreira, DM; Castro-Santamaria, R; Andriole, GL; Vidal, AC; Freedland, SJ

Published Date

  • June 2016

Published In

Volume / Issue

  • 19 / 2

Start / End Page

  • 202 - 208

PubMed ID

  • 26926927

Pubmed Central ID

  • 26926927

Electronic International Standard Serial Number (EISSN)

  • 1476-5608

International Standard Serial Number (ISSN)

  • 1365-7852

Digital Object Identifier (DOI)

  • 10.1038/pcan.2016.5

Language

  • eng