Clinical Trial

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

Recruiting Phase 2
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Summary
Asymptomatic patients with metastatic castrate resistant prostate cancer (mCRPC) without pain due to prostate cancer will be treated on an open label study to evaluate effectiveness of sequential treatment with the combination of difluoromethylornithine (DFMO) and high dose testosterone in sequence with enzalutamide to improve primary and secondary outcomes.
Protocol Amendment History 4 amendments
This ClinicalTrials.gov record has been amended 4 times since 2023-09-22; most recent amendment 2026-01-13.
Status change: Not Yet Recruiting → Recruiting 2023-10-20
Trial Details
NCT Number NCT06059118
Lead Sponsor Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Collaborators: Panbela Therapeutics, Prostate Cancer Foundation, United States Department of Defense
Conditions Prostate Cancer
Enrollment 50 participants
Start Date 2023-10-04
Primary Completion 2027-01-04 (estimated)
Study Completion 2029-11-30 (estimated)
Updated on ClinicalTrials.gov 2026-01-14