A phase II trial evaluating the efficacy and safety of efavirenz in metastatic castration-resistant prostate cancer.

ABSTRACT:

Background

Preclinical studies demonstrated that non-nucleoside reverse transcriptase inhibitors used for the treatment of HIV could antagonize tumor development. This led us to assess the efficacy of efavirenz in patients with metastatic castration-resistant prostate cancer (mCRPC) in a multicenter phase II study.

Methods

We used a Simon two-stage design and a 3-month prostate-specific antigen (PSA) nonprogression rate of 40% as a primary objective. Patients received 600 mg efavirenz daily with the possibility of a dose increase in case of PSA progression. Exploratory analyses included pharmacokinetics of efavirenz plasma concentrations and correlations with clinical outcomes.

Results

Among 53 assessable patients, we observed 15 instances of PSA nonprogression at 3 m

SUBMITTER: Houede N 

PROVIDER: S-EPMC4257751 | biostudies-literature | 2014 Dec

REPOSITORIES: biostudies-literature