Safety Study of Continued Enzalutamide Treatment In Prostate Cancer Patients

Status: Closed to Accrual

Description

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

Eligibility 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

Locations & Contacts

See trial information on ClinicalTrials.gov for a list of participating sites.

Trial Phase & Type

Trial Phase

Phase IV

Trial Type

Treatment

Lead Organization

Lead Organization
Pfizer

Trial IDs

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