An Asian Study to Evaluate Efficacy and Safety of Oral Enzalutamide in Progressive Metastatic Prostate Cancer Participants

• Status: Active, not recruiting
• Trial end date: 2022-09-30
• Target enrollment: 0
• Participant gender: Male

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.

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

Details

• Lead Sponsor: Astellas Pharma Inc
• Treatments: Androgens

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).