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DFMO, Testosterone, and Enzalutamide for Metastatic Prostate Cancer

This study is for men with metastatic castration-resistant prostate cancer (mCRPC), meaning their prostate cancer has spread and is no longer responding to standard hormone therapy. You may be eligible if you've already had treatment with Abiraterone (Abi) and your cancer has progressed. The study will test a sequence of treatments: first, difluoromethylornithine (DFMO) and high-dose testosterone, followed by enzalutamide. The goal is to see how well this combination works to improve outcomes. Researchers will measure how many participants have a PSA (prostate-specific antigen) response after the first cycle of treatment. The study plans to enroll 50 participants.

Study design
This is an open-label study, meaning you and your doctors will know which treatments you are receiving. It plans to enroll 50 participants.
What's involved
Each treatment cycle lasts 119 days. You will take DFMO by mouth twice a day for 63 days, receive testosterone injections on Day 8 and Day 36, and then take enzalutamide by mouth once a day for 56 days. You will continue these cycles until your cancer progresses or side effects require stopping.
Compensation
Not stated in the trial record.
Follow-up
The primary outcome, PSA response rate, is measured at Cycle 1 Day 64.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06059118

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

Recruiting
PHASE2Ages 18+InterventionalTreatment
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
~50 participants
Updated 2026-01-14 on ClinicalTrials.gov
What's tested:DFMOtestosterone cypionateLuteinizing hormone-releasing hormone (LHRH) analogueEnzalutamide

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
PSA response rate at Cycle 1 Day 64
Measured over Cycle 1 Day 64 (each cycle is 119 days)

Conditions

Prostate Cancer

Explore related trials

Prostate Carcinoma

Where it's being run

1 sites across 1 states
Maryland1

Study leadership

  • Laura Sena, MD, PhD · PRINCIPAL_INVESTIGATOR · Johns Hopkins University

Who to contact

Laura Sena, MD, PhD
[email protected]
410-502-3825
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

PSA progression defined as an increase in PSA, as determined by 2 separate measurements taken at least 1 week apart And/ Or
Radiographic disease progression, based on RECIST 1.1 in patients with measurable soft tissue lesions or Prostate Cancer Working Group 3 (PCWG3) for patients with bone disease 8. Screening PSA must be ≥ 1.0 ng/mL. 9. Patients with soft tissue lesion amenable to biopsy must agree to biopsy collection pre-treatment and at a defined point on treatment to perform tumor tissue analysis. 10. Prior treatment with Provenge vaccine, 223Radium (Xofigo), Poly (ADP-ribose) polymerase (PARP) inhibitors, taxane chemotherapy, Lutetium prostate-specific membrane antigen (LuPSMA), antiandrogens (including enzalutamide, darolutamide, and apalutamide), and radiation is allowed if \>4 weeks from last dose. 11. Prior treatment with bipolar androgen therapy (BAT) is allowed if the patient has progressed on an AR-axis inhibitor (i.e. abiraterone or antiandrogen) since BAT treatment. 12. Patients must be withdrawn from abiraterone for ≥ 2 weeks. 13. Attempts must be made to wean patients off prednisone prior to starting therapy. Patients who cannot be weaned due to symptoms may continue on lowest dose of prednisone achieved during weaning period. 14. Acceptable liver function:
Are abstinent from penile-vaginal intercourse as their usual and preferred lifestyle (abstinent on a longterm and persistent basis) and agree to remain abstinent.
Are sterilized (with the appropriate post-vasectomy documentation of the absence of sperm in the ejaculate);
Agree to use a male condom and have their partner use a contraceptive method with a failure rate of \<1% per year as described below when having penile-vaginal intercourse with a woman of childbearing potential who is not currently pregnant, and who agrees to the use of a condom by her partner.

What this trial measures

  • PSA response rate at Cycle 1 Day 64Cycle 1 Day 64 (each cycle is 119 days)

    Number of participants with \>50% PSA decline from baseline by Cycle 1 Day 64.