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

Part of paid clinical trials in Baltimore, Maryland.

Sponsor
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Study ID
NCT06059118
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
MALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • DFMO — DRUG
    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.
  • testosterone cypionate — DRUG
    On Day 8 and Day 36 of each 119 day cycle, patient will receive high dose testosterone at 400 mg through intramuscular (IM) injection.
  • Luteinizing hormone-releasing hormone (LHRH) analogue — DRUG
    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.
  • Enzalutamide — DRUG
    Each 119 day cycle, Days 64-119 patient will take 160 mg by mouth (PO) once a day (qd).

Study Details

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.

Key Dates

Start date
Oct 4, 2023
Status verified
Jan 2026
Primary completion
Jan 4, 2027
Completion
Nov 30, 2029

Study Design

Enrollment
50 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Repeat Sequential DFMO and High dose Testosterone in Sequence with Enzalutamide
    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).

Primary Outcome Measure

PSA response rate at Cycle 1 Day 64 [ Time Frame: Cycle 1 Day 64 (each cycle is 119 days) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Johns Hopkins University: Sidney Kimmel Comprehensive Cancer CenterBaltimoreMaryland21287
Kathy Schultz, RN
[email protected]
410-614-9482
Laura Sena, MD,PhD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Baltimore, MD

By condition
Prostate cancer
By specialty
OncologyProstate oncologyMen's healthUrology
By research site
Johns Hopkins University: Sidney Kimmel Comprehensive Cancer Center· Baltimore, MD

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