Figure 1. Recruitment, Randomization, and Patient Flow.

^aThe unmet eligibility criteria were not captured as part of the protocol.

^bCentralized pathology review was conducted by a single pathologist on tissue specimens collected at diagnosis to determine tumor volume and Gleason scores.

^cThe unmet inclusion criteria included baseline prostate-specific antigen level greater than 10 ng/mL (n = 1) and more than 25% biopsy tissue cores positive for cancer (n = 1).

^dThe unmet inclusion criteria included baseline prostate-specific antigen level greater than 10 ng/mL (n = 1), more than 25% biopsy tissue cores positive for cancer (n = 2), Gleason score of 7 for men aged 70 years or younger (n = 1), and consumed 6 or more servings per day of fruits and vegetables (n = 1).