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

• Status: Completed
• Trial end date: 2019-02-14
• Target enrollment: 0
• Participant gender: Male

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Medivation, Inc.; Pfizer
• Collaborators: Astellas Pharma Inc; Medivation LLC, a wholly owned subsidiary of Pfizer Inc.

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