A Phase II Study of ARN-509, Abiraterone Acetate, Leuprolide, and Hypofractionated Radiation Therapy in Men with Very High-Risk Prostate Cancer

Full Title

ARN-509+Abiraterone acetate+Leuprolide with Stereotactic, Ultra-Hypofractionated Radiation (AASUR) in Very High Risk Prostate Cancer: A Single Arm, Phase II Study

Purpose

The purpose of this study is to determine whether anti-testosterone medications, when given before, during, and after high-dose precision radiation therapy, will be effective in preventing prostate cancer from returning. The anti-testosterone drugs are ARN-509, abiraterone acetate, and leuprolide.

ARN-509 is an investigational drug designed to inhibit prostate cancer growth by blocking a protein called the androgen receptor. Abiraterone, which is given with prednisone, works by blocking the production of testosterone by inhibiting an enzyme called CYP17. The radiation therapy in this study is "ultra-fractionated," meaning higher doses are given over a shorter overall course of treatment.

Eligibility

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • Patients must have newly diagnosed, previously untreated prostate cancer that has a very high risk of returning after standard therapy.
  • Patients may not have metastatic prostate cancer.
  • This study is open to men ages 18 and older.

For more information about this study and to inquire about eligibility, please contact Dr. Sean McBride at 212-639-5717.

Protocol

15-334

Phase

II

Disease Status

Newly Diagnosed

Investigator