- Gritz, E. R;
- Arnold, K. B;
- Moinpour, C. M;
- Burton-Chase, A. M;
- Tangen, C. M;
- Probstfield, J. F;
- See, W. A;
- Lieber, M. M;
- Caggiano, V.;
- Moody-Thomas, S.;
- Szczepanek, C.;
- Ryan, A.;
- Carlin, S.;
- Hill, S.;
- Goodman, P. J;
- Padberg, R. M;
- Minasian, L. M;
- Meyskens, F. L;
- Thompson, I. M
Background: The Prostate Cancer Prevention Trial (PCPT) was a 7-year randomized, double-blind, placebocontrolled trial of the efficacy of finasteride for the prevention of prostate cancer with a primary outcome of histologically determined prevalence of prostate cancer at the end of 7 years. Methods: A systematic modeling process using logistic regression identified factors available at year 6 that are associated with end-of-study (EOS) biopsy adherence at year 7, stratified by whether participants were ever prompted for a prostate biopsy by year 6. Final models were evaluated for discrimination. At year 6,13,590 men were available for analysis. Results: Participants were more likely to have the EOS biopsy if they were adherent to study visit schedules and procedures and/or were in good health (P < 0.01). Participants at larger sites and/or sites that received retention and adherence grants were also more likely to have the EOS biopsy (P < 0.05). Conclusions: Our results show good adherence to study requirements 1 year before the EOS biopsy was associated with greater odds that a participant would comply with the invasive EOS requirement. Impact: Monitoring adherence behaviors may identify participants at risk of nonadherence to more demanding study end points. Such information could help frame adherence intervention strategies in future trials. © 2014 American Association for Cancer Research.