Relugolix + Enzalutamide Study in High-Risk Prostate Cancer

Prior treatment

• Patients who are receiving any other investigational agents.
• Not a candidate for surgical or radiation therapy

Other illness

• History of major adverse cardiac event, including myocardial infarction, new congestive heart failure (CHF) or CHF exacerbation, or stroke, within the past 6 months.
• Patients with distant metastatic cancer will be excluded from the study as intermittent hormonal therapy is not standard of care treatment for this population.
• Active secondary malignancies requiring treatment
• History of allergic reactions attributed to compounds of similar chemical or biologic composition to any of study drugs
• Participants with uncontrolled intercurrent illness.

Other

• Participant is unable to swallow pills.

• Capable of giving signed informed consent;
• Patients must be ≥18 years of age at the time of signing the informed consent form.
• Men with a diagnosis of adenocarcinoma of the prostate pathologically proven diagnosis with the following:
  • Locally advanced high-risk prostate defined as i. PSA \>20 ng/mL or ISUP grade 4/5 (Gleason score \>7) or cT2c or ii. Any PSA, any ISUP grade, cT3-4 or cN+ (locally advanced)
• Have normal organ and bone marrow function measured at the screening visit including
  • Platelets ≥100 × 103/microliter (μL);
  • Hemoglobin ≥ 10.0 grams/dL;
  • Leukocytes (WBC) ≥ 3 × 103/μL;
  • Absolute neutrophil count ≥1.5 × 103/μL;
  • Serum AST and ALT ≤2.5 × upper limit of normal (ULN);
  • Total bilirubin ≤1.5 ×ULN (unless values are consistent with Gilbert's syndrome for which the total bilirubin must be \< 3x ULN);
  • Serum creatinine ≤ 1.5 × ULN; OR Measured or calculated creatinine clearance ≥30 mL/min for participant with creatinine levels \>1.5 × institutional ULN
• Eastern Cooperative Oncology Group (ECOG) performance status 0-2.
• The participant has, in the opinion of the investigator, a life expectancy of at least 6 months.
• Male patients must be willing to use contraception during treatment and for 3 months after the last dose of study treatment when having sexual intercourse with a pregnant woman or with a woman of childbearing potential. Female partners of male patients should also use a highly effective form of contraception if they are of childbearing potential.