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2023 Sun Pharma-PCF VAlor Special Challenge Award

A Phase 2 Randomized Study of YONSA® (Abiraterone Acetate), Enzalutamide or Apalutamide as First Line Therapy in Veterans with Castrate-Sensitive Prostate Cancer

Principal Investigators: Antonio Tito Fojo, MD (James J. Peters Veterans Affairs Medical Center), Susan Bates, MD (James J. Peters Veterans Affairs Medical Center)

Description:

  • Prostate cancer is a serious health problem among Veterans and was the second leading cause of cancer death in American men in 2019. Although many patients in the past seven years have experienced improved survival with novel hormonal therapies (abiraterone acetate and enzalutamide), most patients experience treatment failure as the cancer develops resistance and disease progresses. Whether earlier treatment may improve ultimate outcomes remains to be determined. Also uncertain is the order in which drugs should be administered.
  • Dr. Antonio Tito Fojo and team are conducting a randomized phase 2 clinical trial in Veterans with prostate cancer to determine if the efficacy of YONSA® (abiraterone acetate) is the optimal and non-inferior first-line therapy for Veterans with castrate-sensitive prostate cancer at the time a recurrence of their disease is first documented, as compared with enzalutamide or apalutamide.
  • Prior studies have also found that the efficacy of abiraterone is superior in African American compared to Caucasian Veterans. This study also aims to demonstrate that abiraterone acetate is more effective in African American than in Caucasian Veterans with castrate-sensitive prostate cancer as initial therapy when a recurrence is first detected.
  • If successful, this study will reinforce an abiraterone-first strategy in the management of Veterans (and all patients) with castrate-sensitive prostate cancer at the time a recurrence is first documented, which is further supported by prior data that enzalutamide is a better salvage (second-line) therapy than abiraterone.

What this means to patients: Abiraterone acetate is a standard of care therapy for advanced prostate cancer, but the loss of patent protection for Zytiga® resulted in a curtailing of its development and slowing of clinical trials to optimize the timing and use of abiraterone in the prostate cancer disease course. As a result, medical oncologists have increasingly been administering enzalutamide or apalutamide before abiraterone, while prior data suggest that abiraterone should precede enzalutamide to achieve maximum benefit and is also a superior choice for African Americans with prostate cancer. This study will provide support for YONSA®, a newer alternative formulation of abiraterone acetate, as part of the first treatment given to patients with a recurrence of prostate cancer, and will lead to new regulatory filings and treatment guidelines for patients with advanced prostate cancer.