We hypothesized that co-targeting AR and cell-cycle with palbociclib (a CDK4/6 inhibitor) would improve outcomes in patients with metastatic hormone-sensitive prostate cancer (mHSPC).
60 patients with Rb-intact mHSPC were randomized (1:2) to Arm 1: androgen deprivation (AD) or Arm 2: AD+ palbociclib.