A Phase III Study of Androgen Annihilation Therapy in Men with Rising PSA after Initial Prostate Cancer Treatment

Full Title

AFT-19: A Phase 3 Study of Androgen Annihilation in High-Risk Biochemically Relapsed Prostate Cancer

Purpose

Prostate cancers initially need the male hormone testosterone for growth. Degarelix is one of the drugs used to treat prostate cancer by reducing testosterone production. In this study, researchers want to see if adding the drug apalutamide (also known as ARN-509) and the drug abiraterone (also known as Zytiga) to treatment with degarelix is more effective than degarelix alone for men whose PSA level is rising after initial surgical therapy (prostatectomy) for prostate cancer. A rising PSA level indicates that the cancer is growing again.

Apalutamide works by blocking the androgen receptor, a protein important in the development and progression of prostate cancer. Patients will be randomly assigned to one of three groups:

  • Degarelix alone
  • Degarelix plus apalutamide
  • Degarelix plus apalutamide and abiraterone acetate

Degarelix is given as an injection, and apalutamide and abiraterone acetate are 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 a PSA level that has doubled in 9 months or less following prior prostatectomy for prostate cancer.
  • Patients with metastatic prostate cancer 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 age 18 and older.

For more information about this study and to inquire about eligibility, please contact Dr. Han Xiao at 908-542-3384.

Protocol

17-480

Phase

III

Investigator

Co-Investigators