A Phase 2 Study to Evaluate the Safety and Efficacy of TAK-385, Together With a Leuprorelin Observational Cohort, in Participants With Prostate Cancer
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Intervention: Relugolix; Leuprorelin
Intervention description: Relugolix tablets; Leuprorelin subcutaneous injection
Intervention MeSH terms: Leuprolide; Relugolix
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 136.0
Sex: Male
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Drug therapy

Summary:

      The purpose of this study is to evaluate the efficacy of TAK 385 for achieving and
      maintaining testosterone suppression (<50 ng/dL).
    

Eligibility criteria:

        Inclusion Criteria

        Each participant must meet all of the following inclusion criteria to be enrolled in the
        study:

          1. Male participant 18 years or older.

          2. Histologically or cytologically confirmed diagnosis of prostate adenocarcinoma.

          3. Candidate for androgen deprivation therapy (ADT) for the management of
             hormone-sensitive prostate cancer with 1 of the following clinical disease states: 1)
             advanced localized disease not suitable for primary therapy, 2) evidence of
             prostate-specific antigen (PSA) biochemical or clinical relapse following primary
             surgery or radiation therapy of curative intent, or 3) newly diagnosed metastatic
             disease that is asymptomatic or not threatening to vital organs.

          4. Appropriate serum testosterone and serum PSA concentration at screening as specified
             in the protocol.

          5. A body mass index (BMI) ≥ 18.0 at screening and/or baseline.

          6. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 at screening
             and/or baseline.

          7. Male participants, even if surgically sterilized, who agree to practice effective
             barrier contraception or agree to practice true abstinence.

          8. Voluntary written consent must be given before performance of any study-related
             procedure not part of standard medical care, with the understanding that consent may
             be withdrawn by the participant at any time without prejudice to future medical care.

          9. Suitable venous access for the study-required blood sampling, including
             pharmacokinetic (PK) and pharmacodynamic (PD) Sampling.

        Exclusion Criteria

        Participants meeting any of the following exclusion criteria are not to be enrolled in the
        study:

          1. In participants with advanced, localized M0N1 or M1 disease, the presence of
             clinically significant symptoms or threat to vital organs requiring immediate
             gonadotropin-releasing hormone (GnRH) /combined or complete androgen blockade (CAB)
             therapy, chemotherapy, or radiotherapy.

          2. Previously received androgen deprivation therapy (ADT) for more than 8 months total
             duration (if ADT was received for 8 months or less, then that ADT must have been
             completed at least 2 years prior to screening).

          3. Visceral metastases (liver or lung).

          4. Features of the participant's medical condition that may make ADT unnecessary or not
             indicated.

          5. Scheduled for additional surgical or (salvage) radiation therapy within 6 months after
             baseline evaluations.

          6. History of surgical castration.

          7. Diagnosis of or treatment for another malignancy within the 2 years before the first
             dose of study drug, or previously diagnosed with another malignancy and have any
             evidence of residual disease. Participants with nonmelanoma skin cancer or carcinoma
             in situ of any type are not excluded if they have undergone complete resection.

          8. Abnormal screening and/or baseline laboratory values as specified in the protocol.

          9. History of any significant cardiac condition within 6 months before receiving the
             first dose of study drug.

         10. Electrocardiogram (ECG) abnormalities as specified in the protocol

         11. Congenital long QT syndrome.

         12. Current use of Class IA (e.g., quinidine, procainamide) or Class III (e.g.,
             amiodarone, sotalol) antiarrhythmic medications.

         13. Uncontrolled hypertension despite appropriate medical therapy. Participants may be
             re-screened after referral and further management of hypertension.

         14. Known, previously diagnosed human immunodeficiency virus (HIV) infection, active
             chronic hepatitis B or C, life-threatening illness unrelated to prostate cancer, or
             any serious medical or psychiatric illness that could, in the investigator's opinion,
             potentially interfere with participation in this study. Specific screening for chronic
             viral illness is at the discretion of the site and/or local institutional review board
             (IRB).

         15. Treatment with any investigational products within 3 months before the first dose of
             study drug.

         16. A primary family member (spouse, parent, child, or sibling of the participant) is
             involved in the conduct of the study or is a study site employee.

         17. Known gastrointestinal (GI) disease or GI procedure that could interfere with the oral
             absorption or tolerance of TAK-385, including difficulty swallowing tablets.

         18. Use of any medication, or food products listed in the excluded medications and dietary
             products table within 2 weeks before the first dose of study drug. Participant must
             have no history of amiodarone use in the 6 months before the first dose of TAK-385.

         19. Admission or evidence of alcohol or drug abuse or use of illicit drugs.