A Phase II Study of Abiraterone Acetate plus Apalutamide for Men with Intermediate- or High-Risk Prostate Cancer Having Prostate Removal Surgery

Full Title

DFCI# 16-223: Phase II Randomized Study of Neoadjuvant and Adjuvant Abiraterone Acetate + Apalutamide for Intermediate-High Risk Prostate Cancer Undergoing Prostatectomy

Purpose

Abiraterone acetate with prednisone is used to treat prostate cancer that has spread to other parts of the body. In this study, researchers are assessing its use in men with localized prostate cancer (confined to the prostate) before surgical removal of the prostate (prostatectomy). Abiraterone acetate with prednisone will also be given with a hormonal therapy called leuprolide.

Apalutamide works by blocking the androgen receptor, a protein important in the development and progression of prostate cancer. In this study, patients with localized intermediate- or high-risk prostate cancer will be randomly assigned to receive abiraterone acetate, prednisone, and leuprolide OR abiraterone acetate, prednisone, leuprolide, and apalutamide before prostate surgery. After surgery, they will receive abiraterone acetate, prednisone, leuprolide, and apalutamide OR no treatment (observation).

Doctors hope that adding apalutamide to treatment will improve outcomes after surgery and reduce the chance that the prostate cancer will come back.

Eligibility

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

  • Patients must have localized, nonmetastatic prostate cancer that has not yet been treated.
  • Patients’ cancers must have an intermediate to high risk of coming back with treatment.
  • 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 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.

Protocol

17-472

Phase

II

Investigator

Co-Investigators