A Phase III Study of Enzalutamide and Leuprolide Alone and Together in Men with Persistent Nonmetastatic High-Risk Prostate Cancer

Full Title

A Phase 3, Randomized, Efficacy and Safety Study of Enzalutamide Plus Leuprolide, Enzalutamide Monotherapy, and Placebo Plus Leuprolide in Men With High-Risk Nonmetastatic Prostate Cancer Progressing After Definitive Therapy

Purpose

Enzalutamide is a standard drug used to treat castration-resistant prostate cancer (cancer which has continued to grow despite hormonal therapy and in the absence of testosterone). It works by blocking a protein called the androgen receptor. Leuprolide is a hormonal therapy also used to treat advanced prostate cancer.

In this study, researchers want to determine if enzalutamide and leuprolide are effective, alone and together, in men with prostate cancer that is continuing to grow despite therapy but has not yet metastasized (spread to other parts of the body). Patients will be randomly assigned to receive enzalutamide alone, enzalutamide with leuprolide, or leuprolide plus a placebo (inactive drug).

Enzalutamide is a capsule that is taken orally (by mouth), and leuprolide is given by injection.

Eligibility

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

  • Patients must have nonmetastatic prostate cancer that has continued to grow despite surgery and/or radiation therapy.
  • Patients must be physically well enough that they are fully ambulatory, capable of all self care, and are capable of all but physically strenuous activities. As an example, patients must be well enough that they would be able to carry out office work or light housework.
  • This study is for patients age 18 and older.

For more information about this study and to inquire about eligibility, please contact Dr. Daniel Danila at 646-422-4612.

Protocol

16-064

Phase

III

Investigator

Co-Investigators