Relugolix + Enzalutamide Study in High-Risk Prostate Cancer

"Dose level of Relugolix and Enzalutamide Safety Lead-in Cohort, 3-12 patient. Relugolix;120 mg, oral, once daily, with a loading dose of 360 mg on day 1, Enzalutamide; 120-160 mg, oral, once daily.~Dose Expansion Cohort, up to 34 patients. Relugolix;120 mg, oral, once daily, with a loading dose of 360 mg on day 1, Enzalutamide; To be determined by safety lead-in cohort.~One cycle = 3 months The dose limiting toxicity (DLT) period is the first 28 days~Neoadjuvant ADT: 6 months; Relugolix: 120 mg orally, daily (with a 360 mg loading dose on day 1, Enzalutamide: 160 mg (or 120 mg) orally, daily~Concurrent ADT during Radiation Therapy; Relugolix: 120 mg orally, daily (with a 360 mg loading dose on day 1, Enzalutamide: 160 mg (or 120 mg) orally, daily~Maintenance ADT: Additional 18 months; Relugolix: 120 mg orally, daily (with a 360 mg loading dose on day 1, Enzalutamide: 160 mg (or 120 mg) orally, daily"