RecruitingPhase 2NCT06059118

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

Repeat Difluoromethylornithine and High Dose Testosterone With Enzalutamide in Asymptomatic Patients With Metastatic Castration-Resistant Prostate Cancer: The APEX (Androgen and Polyamine Elimination Alternating With Xtandi) Trial

Sponsor

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Enrollment

50 participants

Start Date

Oct 4, 2023

Study Type

INTERVENTIONAL

Conditions

Prostate Cancer

Summary

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.

Eligibility

Sex: MALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing a combination of three treatments for men with advanced prostate cancer that no longer responds to hormone therapy (castration-resistant prostate cancer): DFMO (a drug that blocks cell growth), high-dose testosterone, and enzalutamide (a hormone blocker). **You may be eligible if...** - You are a man aged 18 or older with confirmed advanced prostate cancer - You are on continuous hormone-blocking therapy (medical or surgical castration) - Your testosterone levels are at castrate range (very low) - Your cancer has spread and was confirmed on scans - Your cancer progressed despite prior treatment with abiraterone acetate **You may NOT be eligible if...** - Your general health is too poor (ECOG score above 2) - You have certain heart, liver, or kidney problems - You have previously been treated with enzalutamide, apalutamide, or darolutamide Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGDFMO

Each 119 day cycle, Days 1-7 patient will take 1000 mg by mouth (PO) twice a day (bid), and then on Day 8 - 63 patient will take 1000 mg PO bid while receiving high dose testosterone IM on Day 8 and Day 36 of cycle.

DRUGtestosterone cypionate

On Day 8 and Day 36 of each 119 day cycle, patient will receive high dose testosterone at 400 mg through intramuscular (IM) injection.

DRUGLuteinizing hormone-releasing hormone (LHRH) analogue

Patients who have progressive disease after treatment with Abiraterone (Abi) will continue with androgen depravation therapy (ADT) with LHRH analogue (LHRH agonist drug (i.e. Zoladex, Trelstar, Eligard or Lupron) or LHRH antagonist drug (Degarelix or Relugolix)). Dosing instructions will vary between the different LHRH analogues. Patients should follow the dosing instructions as directed by their physician.

DRUGEnzalutamide

Each 119 day cycle, Days 64-119 patient will take 160 mg by mouth (PO) once a day (qd).

Locations(1)

Johns Hopkins University: Sidney Kimmel Comprehensive Cancer Center

Baltimore, Maryland, United States

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NCT06059118

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