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OncoMatch/Clinical Trials/NCT06059118

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

Is NCT06059118 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including DFMO and testosterone cypionate for prostate cancer.

Phase 2RecruitingSidney Kimmel Comprehensive Cancer Center at Johns HopkinsNCT06059118Data as of May 2026

Treatment: DFMO · testosterone cypionate · Luteinizing hormone-releasing hormone (LHRH) analogue · Enzalutamide — 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.

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Extracted eligibility criteria

Cancer type

Prostate Cancer

Disease stage

Metastatic disease required

Performance status

ECOG 0–2(Ambulatory, capable of self-care)

Prior therapy

Must have received: androgen deprivation therapy (surgical castration, LHRH agonist, LHRH antagonist) — continuous

Treated with continuous androgen ablative therapy (either surgical castration or LHRH agonist/antagonist)

Must have received: abiraterone (abiraterone acetate)

Must have had disease progression while on abiraterone acetate

Lab requirements

Blood counts

ANC ≥ 1500/mm3; Platelets ≥ 100,000/mm3; Hemoglobin ≥ 8 g/dL

Kidney function

GFR ≥ 50 mL/min/1.73 m2 (CKD-EPI equation)

Liver function

Bilirubin < 2.5x ULN; AST and ALT < 2.5x ULN

Acceptable liver function: Bilirubin < 2.5x ULN; AST and ALT < 2.5x ULN. Acceptable renal function: GFR ≥ 50 mL/min/1.73 m2. Acceptable hematologic status: ANC ≥ 1500/mm3; Platelet count ≥ 100,000/mm3; Hemoglobin ≥ 8 g/dL.

Structured fields extracted by AI. May contain errors — verify against the official protocol.

US trial sites

  • Johns Hopkins University: Sidney Kimmel Comprehensive Cancer Center · Baltimore, Maryland

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