PURPOSE: We describe the complexities of the study design of the PCPT and how they
influenced the end point chosen, trial implementation, analysis and interpretation of the
results. MATERIALS AND METHODS: Data from the PCPT are provided to evaluate and
quantify the potential biases of this trial design. RESULTS: Six potential sources of bias,
including prostate specific antigen, digital rectal examination, prostate biopsy technique,
study medication nonadherence and contamination, and transurethral prostate resection are …