At a glance
ClinicalIndex Comparison Record- ✓Histologically-confirmed adenocarcinoma of the prostate
- ✓Continuous androgen ablative therapy with castrate testosterone levels <50 ng/dl
- ✓Metastatic disease documented by CT or bone scan
- ✓Disease progression on abiraterone acetate (PSA or radiographic)
- ✕Pain from metastatic prostate cancer requiring opioid medication
- ✕ECOG performance status ≥3
- ✕Requirement for urinary self-catheterization for obstruction
- ✕Disease extent posing risk from testosterone therapy (femoral metastases, spinal metastases with cord compression risk, extensive liver metastases)
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 2 clinical trial evaluating DFMO, testosterone cypionate, and 2 other interventions for Prostate Cancer. Currently recruiting, targeting 50 participants across 1 site.
Detailed 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.
Study Details
Timeline
Interventions
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.
On Day 8 and Day 36 of each 119 day cycle, patient will receive high dose testosterone at 400 mg through intramuscular (IM) injection.
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.
Each 119 day cycle, Days 64-119 patient will take 160 mg by mouth (PO) once a day (qd).