Phase 3
Completed N=395
An Asian Study to Evaluate Efficacy and Safety of Oral Enzalutamide in Progressive Metastatic Prostate Cancer Participants
Progressive Metastatic Prostate Cancer
Source: ClinicalTrials.gov NCT02294461 ↗
Enrolled (actual)
395
Serious AEs
37.7%
Results posted
Apr 2017
Primary outcomePrimary: Time to Prostate-specific Antigen (PSA) Progression — 8.31; 2.86 Months — p=<0.0001
◆ Published Evidence
Established
20citations · ~5 / year
Enzalutamide in Chemotherapy-Naïve Metastatic Castration-Resistant Prostate Cancer: An Asian Multiregional, Randomized Study.
Summary
Purpose of the study was to assess the effect of enzalutamide on time to Prostate Specific Antigen (PSA) progression as compared to placebo in chemotherapy naïve participants with progressive metastatic prostate cancer who have failed androgen deprivation therapy.
Linked Publications
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Enzalutamide in Chemotherapy-Naïve Metastatic Castration-Resistant Prostate Cancer: An Asian Multiregional, Randomized Study.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Time to Prostate-specific Antigen (PSA) Progression |
8.31; 2.86 | <0.0001 sig |
| SECONDARY Duration of Overall Survival |
39.06; 27.10 | 0.0208 sig |
| SECONDARY Duration of Radiographic Progression-free Survival (rPFS) Based on Independent Central Review Facility Assessment |
NA; 5.29 | <0.0001 sig |
| SECONDARY Time to First Skeletal-Related Event |
NA; NA | 0.2501 |
| SECONDARY Time to Initiation of Cytotoxic Chemotherapy |
NA; 13.93 | 0.0020 sig |
| SECONDARY Number of Participants With Confirmed Best PSA Response (≥50% Decrease From Baseline) |
120; 15 | <0.0001 sig |
| SECONDARY Best Overall Soft Tissue Response |
18; 1 | <0.0001 sig |
| SECONDARY Time to Maximum Concentration (Tmax) of Enzalutamide, M1,M2 and Enzalutamide Plus M2 |
0.975; 24.0; 24.0; 0.975; 1.00; 1.02 | — |
| SECONDARY Maximum Observed Plasma Concentration During the First 24 Hours After Dosing (Cmax) Enzalutamide, M1,M2 and Enzalutamide Plus M2 |
3.92; 0.112; 0.175; 3.94; 20.0; 14.0 | — |
| SECONDARY AUC From the Time of Dosing to 24 h After Dosing (AUC24h) Enzalutamide, M1,M2 and Enzalutamide Plus M2 |
43.1; 1.81; 2.17; 45.3 | — |
| SECONDARY Concentration 24 h After Dosing (C24h) Enzalutamide, M1,M2 and Enzalutamide Plus M2 |
1.65; 0.111; 0.164; 1.82; 17.6; 6.09 | — |
| SECONDARY Observed Plasma Concentration in Predose Samples Obtained During Multiple-dose Administration of Minimum Concentration (Plasma Concentration at Pre Dose) (Cmin) Enzalutamide, M1,M2 and Enzalutamide Plus M2 |
1.65; 0.111; 0.164; 1.82; 3.29; 0.302 | — |
| SECONDARY Apparent Total Systemic Clearance After Multiple Dosing (CL/F) Enzalutamide, M1,M2 and Enzalutamide Plus M2 (For Unchanged Enzalutamide Only) |
0.387; NA; NA; NA | — |
| SECONDARY Peak-Trough Ratio (PTR) Enzalutamide, M1,M2 and Enzalutamide Plus M2 |
1.15; 1.19; 1.09; 1.08 | — |
| SECONDARY AUC From the Time of Dosing to the Start of the Next Dosing Interval (AUCtau) Enzalutamide, M1,M2 and Enzalutamide Plus M2 |
427; 149; 308; 735 | — |
| SECONDARY Number of Participants With Adverse Events (AE) |
190; 166; 47; 98; 66; 28 | — |
Eligibility Criteria
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 bone 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
- History of seizure including febrile seizure or any condition that may predispose to seizure (e.g., prior stroke, brain arteriovenous malformation, head trauma with loss of consciousness requiring hospitalization).
Data sourced from ClinicalTrials.gov (NCT02294461) and the linked publication. 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.