Safety Study of Continued Enzalutamide Treatment In Prostate Cancer Patients

• Status: Active, not recruiting
• Trial end date: 2024-05-31
• Target enrollment: 0
• Participant gender: Male

Summary

The purpose of this study is to determine if continued treatment with Enzalutamide is effective in patients with metastatic prostate cancer.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Medivation, Inc.; Pfizer
• Collaborators: Astellas Pharma Inc; Medivation is now a wholly owned subsidiary of Pfizer Inc.; Medivation LLC, a wholly owned subsidiary of Pfizer Inc.
• Treatments: Abiraterone Acetate; Prednisolone; Prednisone

Criteria

Inclusion Criteria:

• Men with metastatic castration-resistant prostate cancer

• Progressive disease on androgen deprivation therapy

• Patients must agree to continue androgen deprivation therapy with a GnRH agonist/antagonist throughout the study or have had a prior bilateral orchiectomy

• ECOG performance score ≤ 1

• Estimated life expectancy of ≥ 12 months

Exclusion Criteria:

• Prior cytotoxic chemotherapy, aminoglutethimide, ketoconazole, abiraterone, or enzalutamide for the treatment of prostate cancer

• Prior participation in a clinical trial of an investigational agent that inhibits the androgen receptor or androgen synthesis (unless the treatment was placebo)

• History of brain metastasis, active leptomeningeal disease or seizure

• Severe cardiovascular or hepatic disease

• Pituitary or adrenal dysfunction