SAABR: Single Arm Phase II Study of AR Targeted Therapy + Atezolizumab + GnRH Analog and Stereotactic Body Radiotherapy (SBRT) to the Prostate in Men With Newly Diagnosed Hormone-sensitive Metastatic Prostate Cancer

NCT04262154 Phase 2 ACTIVE_NOT_RECRUITING Results posted

This study is to find out whether adding the study drug atezolizumab and stereotactic body radiotherapy (SBRT) to standard treatment with abiraterone acetate, prednisone, and Lupron® (leuprolide) is a safe and effective way to treat previously untreated metastatic prostate cancer, and to see whether the study treatment works better than the standard treatment.

Details

Lead sponsor	Memorial Sloan Kettering Cancer Center
Phase	Phase 2
Status	ACTIVE_NOT_RECRUITING
Enrolment	28
Start date	2020-03-03
Completion	2026-09

Conditions

• Metastatic Prostate Cancer

Interventions

• Atezolizumab
• Abiraterone
• Prednisone
• GnRH analog
• Stereotactic Body Radiotherapy (SBRT)
• Enzalutamide
• Follow up

Primary outcomes

• Failure-free Rate at 2 Years — 2 years
  Failure is defined as: biochemical failure, radiographic progression defined by PCWG3, or death from any cause.

Countries

United States