A Phase III Study of Abiraterone/Prednisone with JNJ-56021927 or a Placebo in Metastatic Castration-Resistant Prostate Cancer that Has Not Been Treated with Chemotherapy

Full Title

A Phase 3 Randomized, Placebo-controlled Double-blind Study of JNJ-56021927 in Combination with Abiraterone Acetate and Prednisone Versus Abiraterone Acetate and Prednisone in Subjects with Chemotherapy-naive Metastatic Castration-resistant Prostate Cancer (mCRPC)

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 (CRPC).

Abiraterone acetate is approved for treating CRPC and is given with the drug prednisone. Abiraterone blocks the production of cancer-fueling testosterone by inhibiting an enzyme called CYP17. In this study, researchers want to see if adding the investigational drug JNJ-56021927 to abiraterone/prednisone treatment is more effective for treating metastatic CRPC than abiraterone/prednisone alone. All of these medications are taken orally (by mouth).

Patients in this study will be randomly assigned to receive abiraterone/prednisone with JNJ-56021927 or abiraterone/prednisone with a placebo (an inactive pill, instead of the investigational drug JNJ-56021927).

Eligibility

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

  • Patients must have metastatic CRPC that has not previously been treated with chemotherapy.
  • At least 4 weeks must pass between the completion of prior hormonal therapy and entry into the study.
  • Patients who previously received abiraterone or enzalutamide may not participate.
  • 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 ages 18 and older.

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

Protocol

15-058

Phase

III

Investigator

Co-Investigators