Study Comparing Orteronel Plus Prednisone in Participants With Chemotherapy-Naive Metastatic Castration-Resistant Prostate Cancer
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Intervention: Orteronel; Placebo; Prednisone
Intervention description: Orteronel will be administered orally twice a day continuously throughout the study. Patients will also receive concomitant gonadotropin-releasing hormone (GnRH) analogue therapy unless they have previously undergone orchiectomy and have a testosterone concentration of <50 ng/dL.; Placebo will be administered orally twice a day continuously throughout the study. Additionally, all patients will receive concomitant gonadotropin-releasing hormone (GnRH) analogue therapy unless they have previously undergone orchiectomy and a testosterone concentration of <50 ng/dL.; Prednisone will be administered orally twice a day continuously throughout the study. Patients will also receive concomitant gonadotropin-releasing hormone (GnRH) analogue therapy unless they have previously undergone orchiectomy and have a testosterone concentration of <50 ng/dL.
Intervention MeSH terms: Prednisone
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 1560.0
Sex: Male
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This is a randomized, double-blind, multicenter, phase 3 study evaluating orteronel (TAK-700)
      plus prednisone compared with placebo plus prednisone in the treatment of men with
      progressive, chemotherapy-naive, metastatic, castration-resistant prostate cancer (mCRPC)
    

Eligibility criteria:

        Inclusion Criteria:

        Each patient must meet all of the following inclusion criteria:

          -  Voluntary written consent

          -  Male patients 18 years or older

          -  Histologically or cytologically confirmed diagnosis of prostate adenocarcinoma

          -  Radiograph-documented metastatic disease

          -  Progressive disease

          -  Prior surgical castration or concurrent use of an agent for medical castration

          -  Either absence of pain or pain not requiring use of any opioid or narcotic analgesia
             in the 2 weeks prior to study entry

          -  Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1

          -  Even if surgically sterilized, patients must practice effective barrier contraception
             during the entire study treatment and for 4 months after the last dose of study drug,
             OR abstain from heterosexual intercourse

          -  Meet screening laboratory values as specified in protocol

          -  Stable medical condition

        Exclusion Criteria:

        Patients meeting any of the following exclusion criteria are not to be enrolled in the
        study:

          -  Known hypersensitivity to orteronel, prednisone or gonadotropin-releasing hormone
             (GnRH) analogue

          -  Received prior therapy with orteronel, aminoglutethimide, ketoconazole or abiraterone

          -  Received antiandrogen therapy within 6 weeks for bicalutamide and 4 weeks for all
             others prior to first dose of study drug

          -  Continuous daily use of oral prednisone or oral dexamethasone for more than 14 days
             within 3 months prior to study

          -  Received prior chemotherapy for prostate cancer with exception of neoadjuvant/adjuvant
             therapy as part of initial primary treatment for local disease that was completed 2 or
             more years prior to screening

          -  Exposure to radioisotope therapy within 4 weeks of receiving first dose of study drug;
             exposure to external beam radiation within 2 weeks of start of screening until
             receiving the first dose of study drug

          -  Documented central nervous system metastases

          -  Treatment with any investigational compound within 30 days prior to first dose of
             study drug

          -  Current spinal cord compression, bilateral hydronephrosis or current bladder neck
             outlet obstruction

          -  Diagnosis or treatment of another malignancy within 2 years preceding first dose of
             study drug except nonmelanoma skin cancer or in situ malignancy completely resected

          -  Uncontrolled cardiovascular condition as specified in study protocol

          -  Known history of human immunodeficiency virus (HIV) infection, hepatitis B, or
             hepatitis C

          -  Unwilling or unable to comply with protocol

          -  Uncontrolled nausea, vomiting or diarrhea

          -  Known gastrointestinal disease or procedure that could interfere with oral absorption
             or tolerance of orteronel