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

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 ID

NCT06059118

Phase

PHASE2

Sponsor

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Status

RECRUITING

Cancer Type

Prostate Cancer

Interventions

DFMO
testosterone cypionate
Luteinizing hormone-releasing hormone (LHRH) analogue
Enzalutamide

Locations (sample)

Baltimore, Maryland, United States|39.29038,-76.61219

Key Eligibility Criteria

Eastern Cooperative Oncology Group (ECOG) Performance status ≤2.
Age ≥18 years.
Histologically-confirmed adenocarcinoma of the prostate.
Treated with continuous androgen ablative therapy (either surgical castration or LHRH agonist/antagonist).

For full eligibility, visit ClinicalTrials.gov.

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