Last reviewed · How we verify
ACTInium-J591 Radionuclide Therapy in PSMA-Detected Metastatic HOrmone-Sensitive Recurrent Prostate CaNcer (ACTION)
The purpose of this study is to evaluate the safety of combining Actinium- J591 with radiation therapy or with androgen deprivation therapy.
Details
| Lead sponsor | Weill Medical College of Cornell University |
|---|---|
| Phase | Phase 1 |
| Status | WITHDRAWN |
| Start date | 2023-12 |
| Completion | 2030-01 |
Conditions
- Prostate Cancer Metastatic
Interventions
- Actinium-J591
- Stereotactic Body Radiation Therapy
- Androgen Deprivation Therapy
Primary outcomes
- Dose Limiting Toxicity (DLT) Rate — 24 months
A DLT will is defined as a grade 3 or higher hematologic adverse event or a grade 2 or higher non-hematologic adverse event deemed to be at least possibly related to study treatment. Adverse events will be assessed using CTCAE version 5. Patients will be observed for a DLT for 3 months from the second dose of actinium-J591. - Change in Maximum Tolerated Dose (MTD) — 3,6,12,18 and 24 months.