Study of Abiraterone Acetate or Enzalutamide, Atezolizumab, GnRH Analog and Radiation Therapy in Men With Newly Diagnosed Hormone-sensitive Prostate Cancer

PHASE2Active, not recruitingINTERVENTIONAL
Enrollment

28

Participants

Timeline

Start Date

March 3, 2020

Primary Completion Date

September 30, 2026

Study Completion Date

September 30, 2026

Conditions
Metastatic Prostate Cancer
Interventions
DRUG

Atezolizumab

Atezolizumab 1200 mg IV over 60 minutes every 3 weeks

DRUG

Abiraterone

Abiraterone 1000 mg daily

DRUG

Prednisone

Prednisone 5 mg daily

DRUG

GnRH analog

Any GnRH analog that is commercially available, injectable, and long acting analog of the native LHRH peptide and is administered to subjects via intramuscular injection. For this study, any GnRH analog can be used and thee manufacturer's instructions for dose and frequency should be followed.

RADIATION

Stereotactic Body Radiotherapy (SBRT)

Intensity-modulated, image-guided, ultra-hypofractionated external beam radiotherapy (7.25-7.5 Gy x 5 to prostate and seminal vesicles QOD) will begin around 12 weeks (at Cycle 5 Day 1 (+/-5 days)

DRUG

Enzalutamide

160 mg once daily

OTHER

Follow up

Subjects who discontinue study treatment for reasons other than progression will be followed every 6 months (+/- 4 weeks) until a documented progression event (i.e., PSA, radiographic, or clinical progression). After a documented progressionevent (whether on treatment or during follow up), subjects will continue to be followed every 6 months (+/- 4 weeks) for overall survival via chart review and/or telephone call.

Trial Locations (8)

10032

Columbia University, New York

10065

Memorial Sloan Kettering Cancer Center, New York

10604

Memorial Sloan Kettering Westchester (Limited Protocol Activities), Harrison

11553

Memorial Sloan Kettering Nassau (Limited Protocol Activities), Uniondale

11725

Memorial Sloan Kettering Cancer Commack (Limited Protocol Activities), Commack

07920

Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities), Basking Ridge

07748

Memorial Sloan Kettering Monmouth (Limited Protocol Activities), Middletown

07645

Memorial Sloan Kettering Bergen (Limited Protocol Activities), Montvale

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Genentech, Inc.

INDUSTRY

collaborator

Stand Up To Cancer

OTHER

lead

Memorial Sloan Kettering Cancer Center

OTHER