A Phase 2 Study to Evaluate the Safety and Efficacy of TAK-385, Together With a Leuprorelin Observational Cohort, in Participants With Prostate Cancer

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.

What this study is about