Safety Study of Continued Enzalutamide Treatment In Prostate Cancer Patients

Status: Recruiting
Diagnosis: Prostate Cancer
NCT ID: NCT01995513 (View complete trial on
DFCI Protocol ID: 13-576


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


Conducting Institutions:
Dana-Farber Cancer Institute, Brigham and Women's Hospital, Beth-Israel Deaconess Medical Center

Overall PI:
Mary-Ellen Taplin, MD, Dana-Farber Cancer Institute

Site-responsible Investigators:
Glenn Bubley, MD, Beth Israel Deaconess Medical Center

Beth-Israel Deaconess Medical Center: Cancer Trials Call Center, 617-667-3060
Dana-Farber Cancer Institute: Judith Prisby, 617-632-5068,
Dana-Farber Cancer Institute: Meghara Walsh, 617-632-5264,
Dana-Farber Cancer Institute: Amanda Fredericks, 617-632-5514,

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
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