102
Participants
Start Date
June 21, 2018
Primary Completion Date
February 14, 2026
Study Completion Date
February 14, 2026
Apalutamide
240mg daily orally
Abiraterone Acetate
1000mg daily orally
Prednisone
5mg BID orally
Radical Prostatectomy
A laparoscopic, robotic-assisted, or open approach to RP is permitted at the discretion of the operating surgeon.
Extended Pelvic lymphadenectomy
To be performed concurrently with prostatectomy. Bilateral pelvic lymphadenectomy should include complete removal of all pelvic lymph nodes within the broad template described and includes the external iliac, hypogastric, obturator, and pre-sacral lymph nodes
GnRH agonist/antagonist
Physician's choice, for a total duration not to extend beyond the treatment phase of the protocol or 10 months from the start of investigational agent(s)
Stereotactic Body Radiation Therapy
Subjects undergo SBRT in cycle 4, then salvage radiation therapy in cycles 7-8. Treatment repeats every 28 days for up to 10 cycles in the absence of disease progression or unacceptable toxicity
Memorial Sloan Kettering Cancer Center, New York
Memorial Sloan Kettering Westchester (Limited Protocol Activities), Harrison
Memorial Sloan Kettering Nassau (Limited Protocol Activities), Uniondale
Memorial Sloan Kettering Commack (Limited Protocol Activities), Commack
Cleveland Clinic, Cleveland
Northwestern University, Evanston
University of Chicago, Chicago
Dana Farber Cancer Institute, Boston
Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities), Basking Ridge
Memorial Sloan Kettering Monmouth (Limited Protocol Activities), Middletown
Memorial Sloan Kettering Bergen (Limited Protocol Activities), Montvale
Dana-Farber Cancer Institute
OTHER
Memorial Sloan Kettering Cancer Center
OTHER