Phase 3
Completed N=1,717
A Safety and Efficacy Study of Oral MDV3100 in Chemotherapy-Naive Patients With Progressive Metastatic Prostate Cancer
Source: ClinicalTrials.gov NCT01212991 ↗Enrolled (actual)
1,717
Serious AEs
36.8%
Results posted
Oct 2014
Primary outcomePrimary: Overall Survival — 32.4; 30.2 months — p=<0.0001
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Overall Survival |
32.4; 30.2 | <0.0001 sig |
| PRIMARY Radiographic Progression-free Survival (rPFS) |
NA; 3.9 | <0.0001 sig |
| SECONDARY Time to First Skeletal-related Event |
31.1; 31.3 | <0.0001 sig |
| SECONDARY Time to Initiation of Cytotoxic Chemotherapy |
28.0; 10.8 | <0.0001 sig |
| SECONDARY Time to Prostate-specific Antigen (PSA) Progression |
11.2; 2.8 | <0.0001 sig |
| SECONDARY Percentage of Patients With Prostate Specific Antigen (PSA) Response ≥ 50% |
78; 3.5 | <0.0001 sig |
| SECONDARY Best Overall Soft Tissue Response |
58.8; 5.0 | <0.0001 sig |
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
Data sourced from ClinicalTrials.gov (NCT01212991). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.