Status:
COMPLETED
An Asian Study to Evaluate Efficacy and Safety of Oral Enzalutamide in Progressive Metastatic Prostate Cancer Participants
Lead Sponsor:
Astellas Pharma Inc
Conditions:
Progressive Metastatic Prostate Cancer
Eligibility:
MALE
18+ years
Phase:
PHASE3
Brief 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 metastat...
Detailed Description
The study was a multinational Phase 3, randomized, double-blind, placebo-controlled efficacy and safety study of oral enzalutamide (formerly MDV3100) in asymptomatic or mildly symptomatic participants...
Eligibility Criteria
Inclusion
- 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
- 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).
Key Trial Info
Start Date :
April 23 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 17 2024
Estimated Enrollment :
395 Patients enrolled
Trial Details
Trial ID
NCT02294461
Start Date
April 23 2014
End Date
July 17 2024
Last Update
October 24 2025
Active Locations (47)
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1
CN00103
Beijing, China
2
CN00104
Beijing, China
3
CN00106
Beijing, China
4
CN00111
Beijing, China