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Clinical Research

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 volume 19, pages 202–208 (2016)Cite this article

Subjects

Abstract

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.

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Acknowledgements

This study was supported by GlaxoSmithKline and NIH 1K24CA160653. ClinicalTrials.gov Identifier: NCT00056407.

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Authors and Affiliations

  1. Division of Urology, Department of Surgery, Duke University School of Medicine, Durham, NC, USA

    S Fischer

  2. Surgery Section, Durham VA Medical Center, Durham, NC, USA

    S Fischer, S Sun, L E Howard, A C Vidal & S J Freedland

  3. Department of Biostatistics and Bioinformatics, Duke University School of Medicine, Durham, NC, USA

    S Sun & L E Howard

  4. Department of Urology, Mayo Clinic, Rochester, MN, USA

    D M Moreira

  5. GlaxoSmithKline Inc., R&D Unit, King of Prussia, PA, USA

    R Castro-Santamaria

  6. Washington University School of Medicine in St. Louis, St. Louis, MI, USA

    G L Andriole

  7. Division of Urology, Department of Surgery, Cedars-Sinai Medical Center, Los Angeles, CA, USA

    A C Vidal & S J Freedland

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  1. S Fischer
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  2. S Sun
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  3. L E Howard
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  6. G L Andriole
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  8. S J Freedland
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Corresponding author

Correspondence to S Fischer.

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Competing interests

This study was supported by GlaxoSmithKline (GSK). Dr Andriole is a consultant to GSK. Dr Castro-Santamaria is an employee of GSK. Dr Freedland received research support from GSK and NIH K24CA160653. The remaining authors declare no conflicts of interest.

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Supplementary Information accompanies the paper on the Prostate Cancer and Prostatic Diseases website

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Fischer, S., Sun, S., Howard, L. 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 Prostatic Dis 19, 202–208 (2016). https://doi.org/10.1038/pcan.2016.5

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