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Neal D. Shore, MD, FACS, discusses the design of the phase 3 HERO trial in patients with advanced prostate cancer.
Neal D. Shore, MD, FACS, medical director, CPI, of the Carolina Urologic Research Center, discusses the design of the phase 3 HERO trial in patients with advanced prostate cancer.
The multinational, open-label, HERO study was designed to evaluate the safety and efficacy of relugolix in patients with advanced prostate cancer, says Shore. A total of 934 patients were enrolled on the global study and they were randomized 2:1 to receive either once-daily relugolix versus 3-month intradermal or subcutaneous leuprolide (Lupron).
The primary end point of the trial was monitoring testosterone suppression through week 48. There were numerous hierarchical secondary end points, says Shore. Investigators also examined testosterone recovery in a subset of approximately 184 patients, concludes Shore.