76
Participants
Start Date
August 12, 2021
Primary Completion Date
October 31, 2027
Study Completion Date
December 31, 2029
225Ac-J591
Alpha-emitter Actinium-225 conjugated to the anti-PSMA antibody J591.
Pembrolizumab
Pembrolizumab will be administered intravenously, 400mg every 6 weeks. Patients may receive maximum 18 cycles of therapy, approximately 2 years.
Androgen receptor inhibitor
Patients will receive an oral androgen receptor inhibitor (ARI). Examples include enzalutamide, apalutamide, darolutamide. Dosing will be the standard dosing, as described by the package insert.
68Ga-PSMA-11
\[185 ±74 MBq or 5 ±2 mCi\] intravenous during screening and 12 weeks. Imaging agent for PSMA PET/CT.
RECRUITING
New York Presbyterian/Weill Cornell Medical Center, New York
RECRUITING
Columbia University Irving Cancer Center, New York
RECRUITING
New York Presbyterian/Brooklyn Methodist Hospital, Brooklyn
NOT_YET_RECRUITING
Dana-Farber Cancer Institute, Boston
United States Department of Defense
FED
Merck Sharp & Dohme LLC
INDUSTRY
Weill Medical College of Cornell University
OTHER