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Safety Study of Continued Enzalutamide Treatment In Prostate Cancer Patients

Trial Status: Closed to Accrual

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

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

Massachusetts

Boston
Beth Israel Deaconess Medical Center
Status: CLOSED_TO_ACCRUAL_AND_INTERVENTION
Dana-Farber Cancer Institute
Status: CLOSED_TO_ACCRUAL_AND_INTERVENTION
Contact: Mary-Ellen Taplin
Phone: 866-790-4500

Trial Phase Phase IV

Trial Type Treatment

Lead Organization
Pfizer

  • Primary ID MDV3100-10
  • Secondary IDs NCI-2014-01568, 2013-000722-54, C3431013, PLATO, C3431013
  • Clinicaltrials.gov ID NCT01995513