A Safety and Efficacy Study of Oral MDV3100 in Chemotherapy-Naive Patients With Progressive Metastatic Prostate Cancer
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Intervention: Enzalutamide; Placebo
Intervention description: Participants received enzalutamide 160 mg, administered as four 40-mg capsules, once per day by mouth. Study drug treatment continued until disease progression (evidence of radiographic progression, a skeletal-related event, or clinical progression) and the initiation of a cytotoxic chemotherapy or an investigational agent, unacceptable toxicity, or withdrawal.; Participants received placebo, administered as four capsules, once per day by mouth. Study drug treatment continued until disease progression (evidence of radiographic progression, a skeletal-related event, or clinical progression) and the initiation of a cytotoxic chemotherapy or an investigational agent, unacceptable toxicity, or withdrawal.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 1717.0
Sex: Male
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Progressive Metastatic Prostate Cancer

Summary:

      The purpose of this study is to determine the benefit of enzalutamide versus placebo as
      assessed by overall survival and progression-free survival in patients with progressive
      metastatic prostate cancer who have failed androgen deprivation therapy but not yet received
      chemotherapy.
    

Eligibility criteria:

        Randomized, Double Blind Treatment Period:

        Inclusion Criteria:

          -  Histologically confirmed adenocarcinoma of the prostate without neuroendocrine
             differentiation or small cell features

          -  Ongoing androgen deprivation therapy with a GnRH analogue or bilateral orchiectomy

          -  Progressive disease despite androgen deprivation therapy as defined by rising PSA
             levels or progressive soft tissue or bony disease

          -  No prior treatment with cytotoxic chemotherapy

          -  Asymptomatic or mildly symptomatic from prostate cancer

        Exclusion Criteria:

          -  Severe concurrent disease, infection, or co-morbidity that, in the judgment of the
             Investigator, would make the patient inappropriate for enrollment

          -  Known or suspected brain metastasis or active leptomeningeal disease

          -  History of another malignancy within the previous 5 years other than curatively
             treated non-melanomatous skin cancer

        Open-Label Treatment Period:

        The following inclusion criteria apply to patients receiving enzalutamide or placebo during
        double-blind treatment.

        Eligible patients must meet all inclusion criteria.

          -  Received randomized double-blind treatment in PREVAIL;

          -  Open-label day 1 visit is within 6 months after this amendment is approved and becomes
             effective at the study site;

          -  Is willing to maintain androgen deprivation therapy with a gonadotropin-releasing
             hormone (GnRH) agonist/antagonist or has had a bilateral orchiectomy;

        The exclusion criteria apply only to patients starting new treatment with enzalutamide
        after receiving placebo as randomized treatment. Each patient must not meet any of the
        following criteria:

          -  Has taken commercially available enzalutamide (Xtandi);

          -  Severe concurrent disease, infection, or co-morbidity that, in the judgment of the
             Investigator, would make the patient inappropriate for enrollment

          -  Known or suspected brain metastasis or active leptomeningeal disease