A Phase III Randomized Study Assessing the Addition of Abiraterone Acetate with Prednisone and Apalutamide to the Usual Hormone Therapy and Radiation Therapy to Treat Recurrent Lymph Node-Positive Prostate Cancer after Surgery

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Full Title

Randomized Phase III Trial Incorporating Abiraterone Acetate with Prednisone and Apalutamide and Advanced Imaging Into Salvage Treatment for Patients with Node-Positive Prostate Cancer After Radical Prostatectomy (INNOVATE) (CIRB)

Purpose

The purpose of this study is to assess the effectiveness of adding apalutamide, abiraterone acetate, and prednisone to the usual hormone therapy and radiation therapy for patients who have a recurrence of their prostate cancer after surgery (prostatectomy). Specifically, there must have been cancer originally found in the lymph nodes at the time of surgery for patients to be eligible for this study. The treatment being evaluated is a “salvage therapy” for recurrent prostate cancer. Patients will be randomly assigned to receive hormone therapy and radiation therapy after prostate cancer surgery with or without apalutamide, abiraterone acetate, and prednisone. 

Androgens (male sex hormones) can cause the growth of prostate cancer cells. Newer anti-hormone drugs such as apalutamide may help stop or slow the growth of prostate cancer cell growth by blocking androgens. Abiraterone acetate, also a newer anti-androgen drug, blocks some of the enzymes needed for androgen production and may cause the death of prostate cancer cells that need androgens to grow. Prednisone is given with abiraterone to replace the corticosteroids that are no longer made by the adrenal glands in the body in the presence of abiraterone.   

Eligibility

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

  • Patients must have prostate cancer, with cancer cells in the lymph nodes, and must have been surgically removed.
  • Patients must have detectable PSA, indicating a recurrence of prostate cancer.
  • There must be no evidence of metastatic prostate cancer.
  • Prior chemotherapy, hormone therapy, or radiation therapy for prostate cancer are not permitted.
  • Patients must be physically well enough that they are fully ambulatory, capable of all self-care, and 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. Craig Grossman at 631-212-6334.

Protocol

21-044

Phase

III

Disease Status

Newly Diagnosed

Investigator