A Phase III Study of ARN-509 versus Placebo in Men with Non-Metastatic Castration-Resistant Prostate Cancer

Protocol
13-243
Full Title
A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase III Study of ARN-509 in Men with Non-Metastatic (M0) Castration-Resistant Prostate Cancer
Phase
III
Purpose

Prostate cancers initially need the male hormone testosterone for growth. Hormone therapies that lower the level of testosterone are among the most effective treatments for prostate cancers that have spread to other organs (metastasized). The benefits of hormone treatments do not last, however. Over time, many prostate cancers continue to grow despite hormonal therapies; these are called “castration-resistant prostate cancers.

The androgen receptor is a protein that is important in the development and progression of prostate cancer. ARN-509 is an investigational drug designed to inhibit prostate cancer growth by blocking the androgen receptor. It is being evaluated in studies of men with castration-resistant prostate cancer that has spread (metastasized) to other parts of the body.

In this study, researchers are evaluating ARN-509 in men with castration-resistant prostate cancer that has not metastasized, but whose PSA levels are rising despite therapy, indicating they have a high risk of developing metastatic cancer. Patients will be randomly assigned to receive ARN-509 (two-thirds of the patients) or a placebo (one-third of the patients). ARN-509 is a capsule that is taken orally (by mouth).

Eligibility

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

  • Patients must have castration-resistant prostate cancer that has not metastasized.
  • At least 4 weeks must have passed since completion of prior therapies and entry into the study.
  • 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 open to men age 18 and older.

For more information about this study and to inquire about eligibility, please contact Dr. Dana Rathkopf at 646-422-4379.

Disease(s)
Prostate Cancer: Rising PSA After Primary Therapy
Locations
Related Diseases