A Safety and Efficacy Study of Oral MDV3100 in Chemotherapy-Naive Patients With Progressive Metastatic Prostate Cancer
Trial ID or NCT#
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.
PREVAIL: A MULTINATIONAL PHASE 3, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED EFFICACY AND SAFETY STUDY OF ORAL MDV3100 IN CHEMOTHERAPY-NAÏVE PATIENTS WITH PROGRESSIVE METASTATIC PROSTATE CANCER WHO HAVE FAILED ANDROGEN DEPRIVATION THERAPY
- - 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
- - 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
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