Study Comparing Orteronel Plus Prednisone in Participants With Metastatic Castration-Resistant Prostate Cancer.
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Intervention: Orteronel; Prednisone; Orteronel Placebo
Intervention description: Orteronel tablets; Prednisone tablets; Orteronel placebo-matching tablets
Intervention MeSH terms: Prednisone
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 1099.0
Sex: Male
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Drug therapy

Summary:

      This is a randomized, double-blind, multicenter, phase 3 study evaluating orteronel plus
      prednisone compared with placebo plus prednisone in men with metastatic, castration-resistant
      prostate cancer (mCRPC) that has progressed following Docetaxel-based therapy
    

Eligibility criteria:

        Inclusion Criteria:

        Each participant must meet all of the following inclusion criteria:

          -  Voluntary written consent

          -  Male 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

          -  Progressive disease during or following 1 or 2 regimens of cytotoxic chemotherapy, 1
             of which must have included docetaxel. Must have received greater than or equal to
             (>=) 360 milligram per square meter (mg/m^2) of docetaxel within a 6-month period.
             Participants who were clearly intolerant to docetaxel or develop progressive disease
             before receiving >= 360 mg/m^2 are also eligible if they have received at least 225
             mg/m^2 of docetaxel within a 6-month period and meet the other study entry criteria.

          -  Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2

          -  Even if surgically sterilized, participants must practice effective barrier
             contraception during the entire study treatment period and for 4 months after the last
             dose of study drug, OR Abstain from heterosexual intercourse

          -  Screening laboratory values as specified in protocol

          -  Stable medical condition

          -  Life expectancy of 6 months or more

          -  Participants who have had up to 2 prior chemotherapy treatments are eligible to
             participate

        Exclusion Criteria:

        Participants 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

          -  Any other therapies for prostate cancer, except for GnRH analogue therapy, must be
             discontinued 2 weeks before the first dose of study drug

          -  Radioisotope therapy or external beam radiation therapy within 4 weeks of 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 (Participants who are in long-term follow-up following active treatment in
             other trials are eligible)

          -  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

          -  Known gastrointestinal disease or procedure that could interfere with oral absorption
             or tolerance of orteronel

          -  Uncontrolled nausea, vomiting, or diarrhea despite appropriate medical therapy

          -  Prostate cancer confined to just the prostrate bed or immediate adjacent tissue