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

StatusRecruiting
PhasePhase 2
Started2023-10-04
View on ClinicalTrials.gov ↗

Amendment history

2026-01-13
Study Status v4
Primary completion date2026-01-04→2027-01-04
2025-02-21
2 amendments v2-v3
2 re-verifications since 2024-02-12, no change to tracked fields
2023-10-20
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v1
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2023-09-30→confirmed 2023-10-04
Study sitesdetails revised at 1 of 1 site
2023-09-22
Original filing
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.
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