A Safety and Efficacy Study of Oral MDV3100 in Chemotherapy-Naive Patients With Progressive Metastatic Prostate Cancer

Trial ID or NCT#

NCT01212991

Status

not recruiting iconNOT RECRUITING

Purpose

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.

Official Title

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

Eligibility Criteria

Ages Eligible for Study: Older than 18 Years
Sexes Eligible for Study: MALE
Accepts Healthy Volunteers: No
Inclusion Criteria:
  1. * 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:
  1. * 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
    1. Open-Label Treatment Period:
    2. The following inclusion criteria apply to patients receiving enzalutamide or placebo during double-blind treatment.
    3. Eligible patients must meet all inclusion criteria.
  2. * 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;
    1. 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:
  3. * 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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Investigator(s)

Sandy Srinivas
Sandy Srinivas
Medical oncologist, Urologic specialist, Genitourinary specialist
Professor of Medicine (Oncology) and, by courtesy, of Urology

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Contact

Cancer Clinical Trials Office
650-498-7061

View on ClinicalTrials.gov