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

Publication ,  Journal Article
Fischer, S; Sun, S; Howard, LE; Moreira, DM; Castro-Santamaria, R; Andriole, GL; Vidal, AC; Freedland, SJ
Published in: Prostate cancer and prostatic diseases
June 2016

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.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.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).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.

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Published In

Prostate cancer and prostatic diseases

DOI

EISSN

1476-5608

ISSN

1365-7852

Publication Date

June 2016

Volume

19

Issue

2

Start / End Page

202 / 208

Related Subject Headings

  • Urology & Nephrology
  • Risk
  • Retrospective Studies
  • Randomized Controlled Trials as Topic
  • Prostatic Neoplasms
  • Patient Compliance
  • Odds Ratio
  • Multicenter Studies as Topic
  • Middle Aged
  • Male
 

Citation

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Fischer, S., Sun, S., Howard, L. E., Moreira, D. M., Castro-Santamaria, R., Andriole, G. L., … Freedland, S. J. (2016). Baseline subject characteristics predictive of compliance with study-mandated prostate biopsy in men at risk of prostate cancer: results from REDUCE. Prostate Cancer and Prostatic Diseases, 19(2), 202–208. https://doi.org/10.1038/pcan.2016.5
Fischer, S., S. Sun, L. E. Howard, D. M. Moreira, R. Castro-Santamaria, G. L. Andriole, A. C. Vidal, and S. J. Freedland. “Baseline subject characteristics predictive of compliance with study-mandated prostate biopsy in men at risk of prostate cancer: results from REDUCE.Prostate Cancer and Prostatic Diseases 19, no. 2 (June 2016): 202–8. https://doi.org/10.1038/pcan.2016.5.
Fischer S, Sun S, Howard LE, Moreira DM, Castro-Santamaria R, Andriole GL, et al. Baseline subject characteristics predictive of compliance with study-mandated prostate biopsy in men at risk of prostate cancer: results from REDUCE. Prostate cancer and prostatic diseases. 2016 Jun;19(2):202–8.
Fischer, S., et al. “Baseline subject characteristics predictive of compliance with study-mandated prostate biopsy in men at risk of prostate cancer: results from REDUCE.Prostate Cancer and Prostatic Diseases, vol. 19, no. 2, June 2016, pp. 202–08. Epmc, doi:10.1038/pcan.2016.5.
Fischer S, Sun S, Howard LE, Moreira DM, Castro-Santamaria R, Andriole GL, Vidal AC, Freedland SJ. Baseline subject characteristics predictive of compliance with study-mandated prostate biopsy in men at risk of prostate cancer: results from REDUCE. Prostate cancer and prostatic diseases. 2016 Jun;19(2):202–208.

Published In

Prostate cancer and prostatic diseases

DOI

EISSN

1476-5608

ISSN

1365-7852

Publication Date

June 2016

Volume

19

Issue

2

Start / End Page

202 / 208

Related Subject Headings

  • Urology & Nephrology
  • Risk
  • Retrospective Studies
  • Randomized Controlled Trials as Topic
  • Prostatic Neoplasms
  • Patient Compliance
  • Odds Ratio
  • Multicenter Studies as Topic
  • Middle Aged
  • Male