A Study to Evaluate the Safety and Efficacy of Relugolix in Men With Advanced Prostate Cancer
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Intervention: Relugolix; Leuprolide Acetate
Intervention description: Relugolix 120-mg tablet administered orally once daily following an oral loading dose of 360 mg (3 x 120-mg tablets) on Day 1; Leuprolide acetate depot suspension, 22.5 mg (or 11.25 mg in Japan, Taiwan, and China), every 3 months by subcutaneous injection
Intervention MeSH terms: Leuprolide; Relugolix
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 1134.0
Sex: Male
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to determine the efficacy and safety of relugolix 120 milligrams
      (mg) orally once daily for 48 weeks on maintaining serum testosterone suppression to castrate
      levels (< 50 nanograms/deciliter [ng/dL]) in participants with androgen-sensitive advanced
      prostate cancer.
    

Eligibility criteria:

        Key Inclusion Criteria:

          1. Has histologically or cytologically confirmed diagnosis of adenocarcinoma of the
             prostate.

          2. Is a candidate for, in the opinion of the investigator, at least 1 year of continuous
             androgen deprivation therapy for the management of androgen-sensitive advanced
             prostate cancer with 1 of the following clinical disease state presentations:

               1. Evidence of biochemical (PSA) or clinical relapse following local primary
                  intervention with curative intent, such as surgery, radiation therapy,
                  cryotherapy, or high-frequency ultrasound and not a candidate for salvage
                  treatment by surgery; or

               2. Newly diagnosed androgen-sensitive metastatic disease; or

               3. Advanced localized disease unlikely to be cured by local primary intervention
                  with either surgery or radiation with curative intent.

          3. Has a serum testosterone at the Screening visit of ≥ 150 ng/dL (5.2 nanomoles
             [nmol]/liter [L]).

          4. Has a serum PSA concentration at the Screening visit of > 2.0 ng/milliliter (mL) (2.0
             microgram [μg]/L), or, when applicable, post radical prostatectomy of > 0.2 ng/mL (0.2
             μg/L) or post radiotherapy, cryotherapy, or high frequency ultrasound > 2.0 ng/mL (2.0
             μg/L) above the post interventional nadir.

          5. Has an Eastern Cooperative Oncology Group performance status of 0 or 1 at initial
             screening and at baseline.

        Key Exclusion Criteria:

          1. In the investigator's opinion, is likely to require chemotherapy or surgical therapy
             for symptomatic disease management within 2 months of initiating androgen deprivation
             therapy.

          2. Previously received gonadotropin-releasing hormone analog or other form of androgen
             deprivation therapy (estrogen or antiandrogen) for > 18 months total duration. If
             androgen deprivation therapy was received for ≤ 18 months total duration, then that
             therapy must have been completed at least 3 months prior to baseline. If the dosing
             interval of the depot is longer than 3 months, then the prior androgen deprivation
             therapy must have been completed at least as long as the dosing interval of the depot.

          3. Previous systemic cytotoxic treatment for prostate cancer (for example, taxane-based
             regimen).

          4. Metastases to brain per prior clinical evaluation.

          5. Participants with myocardial infarction, unstable symptomatic ischemic heart disease,
             cerebrovascular events, or any significant cardiac condition within the prior 6
             months.

          6. Active conduction system abnormalities.

          7. Uncontrolled hypertension.