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DFMO + Testosterone + Enzalutamide for Prostate Cancer

Phase 2
Recruiting
Led By Laura Sena, MD, PhD
Research Sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age ≥18 years.
- 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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 years after end of treatment
Awards & highlights

Study Summary

This trial studies a combination of drugs for asymptomatic mCRPC patients to improve outcomes, without causing pain.

Who is the study for?
Men over 18 with advanced prostate cancer that's resistant to castration and has spread, who have low testosterone levels and disease progression despite previous treatments. They must not be on certain blood thinners or have had major surgery recently, among other criteria.Check my eligibility
What is being tested?
The trial tests a combination of DFMO (a drug) and high dose testosterone followed by enzalutamide (another drug) in men with metastatic castrate-resistant prostate cancer. It aims to see if this sequence improves outcomes compared to current treatments.See study design
What are the potential side effects?
Potential side effects may include issues related to hormone therapy such as mood swings, increased red blood cell count, acne or oily skin, mild fluid retention, stimulation of prostate tissue and growth of existing prostate cancer.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 18 years old or older.
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My cancer has grown or spread, as shown by recent scans.
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I am sterilized and have documentation proving I have no sperm in my ejaculate.
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I will use protection or abstain if my partner is pregnant or breastfeeding.
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I choose not to have penile-vaginal sex and will continue this choice.
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My testosterone levels are very low (<50 ng/dl).
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My kidney function is good, with a GFR of 50 mL/min/1.73 m2 or higher.
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I can take care of myself but might not be able to do heavy physical work.
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My prostate cancer is confirmed by a tissue examination.
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I am undergoing hormone therapy for cancer.
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My condition worsened while I was on abiraterone acetate.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 years after end of treatment
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 years after end of treatment for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
PSA response rate at Cycle 1 Day 64
Secondary outcome measures
Measurable disease response rate
PSA progression-free survival (PSA-PFS)
PSA response rate at any timepoint
+4 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: Repeat Sequential DFMO and High dose Testosterone in Sequence with EnzalutamideExperimental Treatment4 Interventions
Eligible patients will receive 7 days of DFMO (1000 mg PO bid) (days 1-7 of cycle), followed by 56 days of combined testosterone (testosterone cypionate 400 mg IM on day 8 and day 36) and DFMO (1000 mg PO bid) (days 8-63 of cycle), followed by 56 days of enzalutamide (160 mg PO daily) (days 64-119).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Enzalutamide
2014
Completed Phase 4
~2760
DFMO
2014
Completed Phase 2
~240

Find a Location

Who is running the clinical trial?

Panbela TherapeuticsIndustry Sponsor
Prostate Cancer FoundationOTHER
47 Previous Clinical Trials
2,730 Total Patients Enrolled
27 Trials studying Prostate Cancer
1,880 Patients Enrolled for Prostate Cancer
Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsLead Sponsor
558 Previous Clinical Trials
32,869 Total Patients Enrolled
56 Trials studying Prostate Cancer
3,298 Patients Enrolled for Prostate Cancer

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is acceptance into this trial still being offered to potential participants?

"This clinical study is not currently open for participation, as indicated by its last update on September 22nd 2023. However, there are 1359 other trials that require participants at this moment in time."

Answered by AI

Are there any risks associated with combining Repeat Sequential DFMO and High dose Testosterone in Sequence with Enzalutamide?

"With prior clinical data confirming its general safety, Repeat Sequential DFMO and High dose Testosterone in Sequence with Enzalutamide received a score of 2 on our risk assessment scale."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Difluoromethylornithine and High Dose Testosterone With Enzalutamide in Metastatic Castration-Resistant Prostate Cancer
2023. "Difluoromethylornithine and High Dose Testosterone With Enzalutamide in Metastatic Castration-Resistant Prostate Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06059118.
All > Testosterone > Metastatic Prostate Cancer
~33 spots leftby Jan 2026
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