Overview

This trial is active, not recruiting.

Condition prostate cancer
Treatments enzalutamide, placebo
Phase phase 3
Target androgen receptor
Sponsor Medivation, Inc.
Collaborator Astellas Pharma Inc
Start date September 2010
End date September 2013
Trial size 1717 participants
Trial identifier NCT01212991, MDV3100-03

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking double blind (subject, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
enzalutamide
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.
(Placebo Comparator)
placebo
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.

Primary Outcomes

Measure
Overall Survival
time frame: During study period (up to 3 years)
Radiographic Progression-free Survival
time frame: During study period (up to 20 months)

Secondary Outcomes

Measure
Time to First Skeletal-related Event
time frame: During study period (up to 3 years)
Time to Initiation of Cytotoxic Chemotherapy
time frame: During study period (up to 3 years)
Time to Prostate-specific Antigen (PSA) Progression
time frame: During study period (up to 3 years)
Percentage of Patients With Prostate Specific Antigen (PSA) Response ≥ 50%
time frame: During study period (up to 3 years)
Best Overall Soft Tissue Response
time frame: During study period (up to 3 years)

Eligibility Criteria

Male participants at least 18 years old.

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

Additional Information

Official title A Multinational Phase 3, Randomized, Double-Blind, Placebo-Controlled Efficacy and Safety Study of Oral MDV3100 in Chemotherapy-Naive Patients With Progressive Metastatic Prostate Cancer Who Have Failed Androgen Deprivation Therapy
Trial information was received from ClinicalTrials.gov and was last updated in February 2016.
Information provided to ClinicalTrials.gov by Medivation, Inc..
Location data was received from the National Cancer Institute and was last updated in August 2016.