Safety Study of Continued Enzalutamide Treatment In Prostate Cancer Patients

Status:	Active, not recruiting
Conditions:	Prostate Cancer, Cancer
Therapuetic Areas:	Oncology
Healthy:	No
Age Range:	18 - Any
Updated:	4/3/2019
Start Date:	November 12, 2013
End Date:	May 31, 2024

A PHASE 4, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY OF CONTINUED ENZALUTAMIDE TREATMENT BEYOND PROGRESSION IN PATIENTS WITH CHEMOTHERAPY-NAÏVE METASTATIC CASTRATION-RESISTANT PROSTATE CANCER

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

We found this trial at

sites

Brigham and Women's Hosp

75 Francis street
Boston, Massachusetts 02115

(617) 732-5500