A Phase II Study of Abiraterone Acetate, Atezolizumab Immunotherapy, Leuprolide, and Radiation Therapy in Men with Newly Diagnosed Metastatic Prostate Cancer

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Full Title

SAABR: Single Arm Phase II Study of Abiraterone + Atezolizumab + Lupron and Stereotactic Body Radiotherapy (SBRT) to the Prostate in Men with Newly Diagnosed Hormone-sensitive Metastatic Prostate Cancer

Purpose

In this study, researchers want to learn if adding atezolizumab immunotherapy and stereotactic body radiotherapy (SBRT) to standard treatment with abiraterone acetate, prednisone, and leuprolide is a safe and effective way to treat previously untreated metastatic prostate cancer.

Atezolizumab works by boosting the ability of the immune system to find and kill cancer cells. SBRT delivers very precisely targeted high-dose radiation in less time than standard radiation therapy, which reduces radiation exposure to healthy tissues near the treatment area. SBRT is not a standard treatment for metastatic prostate cancer, but it has been shown to be a safe and effective treatment for cancer that is contained within the prostate. In this study, SBRT will be delivered only to the prostate and not to any sites of metastasis. The study researchers think that adding SBRT will enhance the effects of the study drugs.

Abiraterone acetate, prednisone, and leuprolide are standard therapies for metastatic prostate cancer and work by reducing levels of cancer-fueling testosterone. They are taken orally (by mouth) and atezolizumab is given intravenously (by vein).

Eligibility

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

  • Patients must have newly diagnosed metastatic prostate cancer that has not yet been treated.
  • 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 and to inquire about eligibility for this study, please contact Dr. Dana Rathkopf at 646-422-4379.

Protocol

19-461

Phase

II

Disease Status

Newly Diagnosed

Investigator

Co-Investigators