Safety and Efficacy of TAK-385 for Patients With Localized Prostate Cancer
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Intervention: TAK-385; Degarelix
Intervention description: TAK-385 tablet; Degarelix injection
Intervention MeSH terms: Relugolix
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 103.0
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.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Is male, 18 years of age or older.

          2. Has histologically confirmed diagnosis of localized prostate adenocarcinoma of
             intermediate risk for which 6-month neoadjuvant and adjuvant androgen deprivation
             therapy (ADT) to EBRT is indicated. Intermediate risk per National Comprehensive
             Cancer Network (NCCN) guidelines includes one of the following:

               1. T2b-T2c disease, or

               2. Gleason score 7, or

               3. Prostate-specific antigen (PSA) 10-20 nanogram per milliliter (ng/mL).

          3. Is scheduled for EBRT to begin greater than or equal to (>=) 12 weeks after the
             Baseline visit.

          4. Has serum testosterone at screening greater then (>) 150 nanogram per deciliter
             (ng/dL) (5.2 nanomoles per liter [nmol/L]).

          5. Has screening serum PSA concentration >2 ng/mL.

          6. Has body mass index (BMI) >=18.0 at screening or baseline.

          7. Has Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 at
             screening or baseline.

          8. Is a male participant, even if surgically sterilized (that is, status postvasectomy),
             who: Agrees to practice effective barrier contraception during the entire study
             treatment period and through 4 months after the last dose of study drug, or, Agrees to
             practice true abstinence, when this is in line with the preferred and usual lifestyle
             of the participant. (Periodic abstinence [example, calendar, ovulation, symptothermal,
             postovulation methods for the female partner] and withdrawal are not acceptable
             methods of contraception.).

          9. Has given voluntary written consent 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.

         10. Has suitable venous access for the study-required blood sampling, including
             pharmacokinetic (PK) and pharmacodynamic sampling.

        Exclusion Criteria:

          1. Has metastatic disease (based on investigator evaluation and assuming no likely
             metastatic pelvic lymph nodes >1.0 cm in long axis diameter).

          2. Had prior or current use of a gonadotropin-releasing hormone (GnRH) analog or androgen
             receptor antagonist as first-line hormone therapy, unless total use was less than 6
             months and not more recently than 1 year before the planned baseline visit.

          3. Had diagnosis of or treatment for another malignancy within 2 years before the first
             dose of study drug, or previous diagnosis of another malignancy with 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.

          4. Has abnormal screening and/or baseline laboratory values that suggest a clinically
             significant underlying disease, or the following laboratory values:

               1. Alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) >1.5 *
                  institutional upper limit of the normal range (ULN);

               2. Serum creatinine >2.0 milligram per deciliter (mg/dL);

               3. Total bilirubin >2.0 * institutional ULN (unless documented Gilbert's disease);

               4. Uncontrolled diabetes (Hemoglobin A1c [HbA1c] >10 [percent] %) or previously
                  undiagnosed diabetes mellitus with HbA1c >8%.

          5. Has history of myocardial infarction, unstable symptomatic ischemic heart disease, any
             ongoing cardiac arrhythmias of Grade >2 (chronic stable atrial fibrillation on stable
             anticoagulant therapy is allowed), thromboembolic events (example, deep vein
             thrombosis, pulmonary embolism, or symptomatic cerebrovascular events), or any other
             significant cardiac condition (example, pericardial effusion, restrictive
             cardiomyopathy) within 6 months before receiving the first dose of study drug.

          6. Has electrocardiogram (ECG) abnormalities of:

               1. Q-wave infarction, unless identified 6 or more months before screening;

               2. Heart rate-corrected QT interval millisecond (msec) (QTcF interval) >480 msec. If
                  QTcF is prolonged in a participant with a pacemaker, the participant may be
                  enrolled in the study upon discussion with the project clinician;

               3. If the QTcF interval is 450-480 msec, inclusive, in a participant with current
                  use of medications with known effects on QT interval, the participant may be
                  enrolled in the study following discussion with the project clinician.

          7. Has congenital long QT syndrome.

          8. Is currently using Class IA (example, quinidine, procainamide) or Class III (example,
             amiodarone, sotalol) antiarrhythmic medications.

          9. Has uncontrolled hypertension despite appropriate medical therapy (sitting blood
             pressure [BP] of greater than 160 millimeters of mercury (mmHg) systolic and 90 mmHg
             diastolic at 2 separate measurements no more than 60 minutes apart during the
             Screening visit). Participants with systolic BP measurements >160 mmHg may be
             rescreened. Participants with systolic BP measurements 141-160 mmHg, although
             eligible, should be referred for further management of hypertension if indicated.

         10. Has 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).

         11. Has received treatment with any investigational products within 3 months before the
             first dose of study drug.

         12. Is a primary family member (spouse, parent, child, or sibling) of anyone involved in
             the conduct of the study or is a study site employee.

         13. Has known gastrointestinal (GI) disease, condition or procedure that could interfere
             with the oral absorption or tolerance of TAK-385, including difficulty swallowing
             tablets.

         14. Is using any medication or food products listed in the excluded medications and
             dietary products table within 2 weeks before the first dose of study drug. This list
             includes moderate and strong inhibitors or inducers of cytochrome P450 (CYP3A4/5) and
             P-glycoprotein (P-gp). Participants must have no history of amiodarone use in the 6
             months before the first dose of TAK-385.

         15. Has admission or evidence of alcohol or drug abuse or use of illicit drugs.