50
Participants
Start Date
October 4, 2023
Primary Completion Date
January 4, 2026
Study Completion Date
November 30, 2029
DFMO
Each 119 day cycle, Days 1-7 patient will take 1000 mg by mouth (PO) twice a day (bid), and then on Day 8 - 63 patient will take 1000 mg PO bid while receiving high dose testosterone IM on Day 8 and Day 36 of cycle.
testosterone cypionate
On Day 8 and Day 36 of each 119 day cycle, patient will receive high dose testosterone at 400 mg through intramuscular (IM) injection.
Luteinizing hormone-releasing hormone (LHRH) analogue
Patients who have progressive disease after treatment with Abiraterone (Abi) will continue with androgen depravation therapy (ADT) with LHRH analogue (LHRH agonist drug (i.e. Zoladex, Trelstar, Eligard or Lupron) or LHRH antagonist drug (Degarelix or Relugolix)). Dosing instructions will vary between the different LHRH analogues. Patients should follow the dosing instructions as directed by their physician.
Enzalutamide
Each 119 day cycle, Days 64-119 patient will take 160 mg by mouth (PO) once a day (qd).
RECRUITING
Johns Hopkins University: Sidney Kimmel Comprehensive Cancer Center, Baltimore
Collaborators (1)
Panbela Therapeutics
INDUSTRY
Prostate Cancer Foundation
OTHER
United States Department of Defense
FED
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
OTHER