Actively Recruiting
Difluoromethylornithine and High Dose Testosterone With Enzalutamide in Metastatic Castration-Resistant Prostate Cancer
Led by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins · Updated on 2026-01-14
50
Participants Needed
1
Research Sites
321 weeks
Total Duration
On this page
Sponsors
S
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Lead Sponsor
P
Panbela Therapeutics
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Difluoromethylornithine and High Dose Testosterone With Enzalutamide in Metastatic Castration-Resistant Prostate Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Eastern Cooperative Oncology Group (ECOG) Performance status 2.
- Age 18 years or older.
- Histologically-confirmed adenocarcinoma of the prostate.
- Continuous androgen ablative therapy (surgical castration or LHRH agonist/antagonist).
- Documented castrate serum testosterone level (<50 ng/dl).
- Radiographically documented metastatic disease by CT or bone scan.
- Disease progression on abiraterone acetate shown by PSA or radiographic progression.
- Screening PSA 61 ng/mL.
- Agree to biopsy collection if soft tissue lesions are present.
- Prior treatments including Provenge, 223Radium, PARP inhibitors, taxane chemotherapy, LuPSMA, antiandrogens, radiation allowed if >4 weeks from last dose.
- Prior bipolar androgen therapy allowed if progressed on AR-axis inhibitor.
- Withdrawn from abiraterone for at least 2 weeks.
- Attempts to wean off prednisone; lowest dose allowed if symptoms require.
- Acceptable liver function: Bilirubin <2.5x ULN; AST/ALT <2.5x ULN.
- Acceptable renal function: GFR 50 mL/min/1.73 m2 or higher.
- Acceptable hematologic status: ANC 615000 cells/mm3; Platelets 61100,000/mm3; Hemoglobin 618 g/dL.
- Willing and able to sign informed consent.
- Sexually active males with female partners of childbearing potential must follow contraception requirements.
- Sexually active males with pregnant/breastfeeding partners must use abstinence or condoms.
- Agree to serial biopsies if soft-tissue disease amenable.
You will not qualify if you...
- Pain from metastatic prostate cancer requiring opioid pain medication.
- ECOG Performance status 3 or higher.
- Need for urinary self-catheterization due to obstruction.
- Disease at sites risking harm from testosterone therapy.
- Active uncontrolled infection.
- Significant mental impairment affecting consent or safety.
- Use of warfarin, rivaroxaban, or apixaban anticoagulants.
- Recent thromboembolic event within last 12 months without anticoagulation treatment.
- Hematocrit >51%, untreated severe obstructive sleep apnea, uncontrolled or poorly controlled heart failure.
- Allergy to sesame seed oil or cottonseed oil.
- Major surgery within 3 weeks before screening or not fully recovered.
- Significant hearing loss affecting daily life.
- History of seizure or conditions predisposing to seizure.
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Trial Site Locations
Total: 1 location
1
Johns Hopkins University: Sidney Kimmel Comprehensive Cancer Center
Baltimore, Maryland, United States, 21287
Actively Recruiting
Research Team
L
Laura Sena, MD, PhD
CONTACT
K
Kathy Schultz, RN
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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