Difluoromethylornithine and High Dose Testosterone With Enzalutamide in Metastatic Castration-Resistant Prostate Cancer

PHASE2RecruitingINTERVENTIONAL
Enrollment

50

Participants

Timeline

Start Date

October 4, 2023

Primary Completion Date

January 4, 2026

Study Completion Date

November 30, 2029

Conditions
Prostate Cancer
Interventions
DRUG

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.

DRUG

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.

DRUG

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.

DRUG

Enzalutamide

Each 119 day cycle, Days 64-119 patient will take 160 mg by mouth (PO) once a day (qd).

Trial Locations (1)

21287

RECRUITING

Johns Hopkins University: Sidney Kimmel Comprehensive Cancer Center, Baltimore

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Panbela Therapeutics

INDUSTRY

collaborator

Prostate Cancer Foundation

OTHER

collaborator

United States Department of Defense

FED

lead

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

OTHER

NCT06059118 - Difluoromethylornithine and High Dose Testosterone With Enzalutamide in Metastatic Castration-Resistant Prostate Cancer | Biotech Hunter | Biotech Hunter