Study of Relugolix in Men With Metastatic Castration-Sensitive Prostate Cancer or Non-Metastatic or Metastatic Castration-Resistant Prostate Cancer

Exclusion Criteria

• •A patient will not be eligible for inclusion in the study if any of the following criteria apply:
• •1. A medical history of brain or hepatic metastases based on radiologic evidence or a medical history of surgical castration;
• •2. Received combination treatment with a GnRH analog or GnRH receptor antagonist with either abiraterone acetate plus a corticosteroid (Part 1) or apalutamide (Part 2) in patients with mCSPC (Part 1 and Part 2) or nmCRPC (Part 2) for a total duration \> 24 months or in patients with mCRPC (Part 1) for a total duration \> 6 months;
• •3. Is scheduled or anticipates being scheduled for major surgery during the study treatment period;
• •4. A current diagnosis of a malignancy other than prostate cancer, with the exception of any of the following:
• •* Adequately treated basal cell carcinoma or squamous cell carcinoma of the skin, or carcinoma in situ of any type;
• •* Adequately treated Stage I cancer that is currently in remission and has been in remission for ≥ 2 years;
• •* Any other cancer from which the patient has been disease-free for ≥ 3 years;
• •5. Abnormal clinical laboratory test value(s) at the screening visit or prior to the baseline (Day 1) visit including:
• •* Serum creatinine \> 2.0 mg/dL;
• •* Platelets \< 100 × 103/μL;
• •* Hemoglobin \< 10.0 g/dL;
• •* Leukocytes (WBC) \< 3 × 103/μL;
• •* Absolute neutrophil count \< 1.5 × 103/μL;
• •* Hemoglobin A1c (HbA1c) \> 8%; Note (Part 3 only): Transfusions and/or administration of growth factors are permitted as indicated for the clinical management of docetaxel-related hematologic effects and in accordance with the investigator's judgement.
• •6. Known hepatic disease, including alcoholic liver disease or viral hepatitis such as hepatitis A (hepatitis A virus IgM positive), chronic hepatitis B (HbsAg positive), or chronic hepatitis C (HCV antibody positive, confirmed by HCV RNA) or clinical signs of hepatic disease such as jaundice;
• •7. A medical history within 6 months prior to the screening visit or a current diagnosis of any of the following:
• •* Myocardial infarction;
• •* Unstable angina;
• •* Unstable symptomatic ischemic heart disease;
• •* Congestive heart failure classified as NYHA class III or IV heart failure;
• •* Thromboembolic event(s) (eg, deep vein thrombosis, pulmonary embolism, or symptomatic cerebrovascular event\[s\]);
• •* Any other significant cardiac condition (eg, pericardial effusion, restrictive cardiomyopathy, severe untreated valvular stenosis, or severe congenital heart disease);
• •8. An abnormal ECG;
• •9. Uncontrolled hypertension;
• •10. Hypotension;
• •11. Bradycardia;
• •12. Positive HIV;
• •13. Medical history of a bleeding disorder or current clinical evidence of gastrointestinal bleeding or active bleeding from another anatomical location;
• •14. A medical history within 1 year of the screening visit of drug or alcohol abuse disorder according to Diagnostic and Statistical Manual of Mental Disorders V;
• •15. Received an investigational drug within 28 days or 5 half-lives, whichever is longer, prior to the baseline (Day 1) visit;
• •16. Prior use of any prohibited medication(s) and restrictive medication(s) without the appropriate washout period or use of a prohibited medication during the study treatment period is planned;
• •17. A contraindication or known history of hypersensitivity to any of the study treatments or components thereof, or has a history of drug or other allergy that, in the opinion of the investigator or medical monitor, contraindicates study participation;
• •18. Any other medical or psychiatric condition that, in the opinion of the investigator, would interfere with accomplishing the study objectives or the patient completing the study;
• •19. Is a study site employee or is a primary family member (spouse, parent, child, or sibling) of a site employee involved in the conduct of the study.