A Phase II Study of Abiraterone Acetate and Apalutamide versus Standard Combination Therapy for Rising PSA after Prostate Cancer Surgery

Full Title

Randomized Phase II Study of Salvage XRT + ADT +/- Abiraterone Acetate and Apalutamide (ARN-509) for Rising PSA after Radical Prostatectomy with Adverse Features. Facilitating Optimal Radiation Management Using Leuprolide, Abiraterone Acetate, and Apalutamide (FORMULA-509 Trial)

Purpose

The purpose of this study is to compare two different combinations of androgen deprivation therapy (ADT, also called hormonal therapy) used together with radiation in men with rising prostate-specific-antigen levels (PSA) after radical prostatectomy (surgical removal of the prostate). Researchers want to know which combination of ADT is better for reducing the risk of prostate cancer recurrence. Patients will be randomly assigned to receive apalutamide and abiraterone acetate plus standard ADT, or standard ADT alone, in addition to radiation therapy.

Abiraterone acetate works by decreasing the production of male sex hormones, which cause prostate cancer to grow. Apalutamide decreases the effects of these hormones. Bicalutamide (part of standard ADT) is commonly used in the treatment of prostate cancer to block testosterone production. These drugs are taken orally (by mouth); patients will also receive ADT by injection every three months for six months.

Eligibility

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

  • Patients must have rising PSA after prostate removal surgery and a PSA doubling time of less than 10 months.
  • Patients must be candidates for radiation therapy and ADT.
  • Patients must be able to walk and do routine activities for more than half of their normal waking hours.
  • This study is for men ages 18-95.

For more information and to inquire about eligibility for this study, please contact Dr. Marisa Kollmeier at 212-639-3952.

Protocol

18-233

Phase

II

Disease Status

Relapsed or Refractory

Investigator