Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06059118 | Difluoromethylornithine and High Dose Testosterone With Enzalutamide in Metastatic Castration-Resistant Prostate Cancer | PHASE2 | RECRUITING | 50 | — | — | Oct 4, 2023 | Nov 30, 2029 | Jan 14, 2026 | 1 | United States |
Number of participants with \>50% PSA decline from baseline by Cycle 1 Day 64.
| Arm | Type | Description |
|---|---|---|
| Repeat Sequential DFMO and High dose Testosterone in Sequence with Enzalutamide | EXPERIMENTAL | 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). |
| Name | Type | Description |
|---|---|---|
| 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). |
Inclusion Criteria: 1. Eastern Cooperative Oncology Group (ECOG) Performance status ≤2. 2. Age ≥18 years. 3. Histologically-confirmed adenocarcinoma of the prostate. 4. Treated with continuous androgen ablative therapy (either surgical castration or LHRH agonist/antagonist). 5. Documented castrate ...