drugset / Trial / NCT06855277
Study Comparing AAA817+ARPI Versus Standard of Care in Adult Participants With PSMA-positive mCRPC
RandomizedParallel-groupOpen-labelDiagnostic
Summary
The purpose of this study is to determine whether \[225Ac\]Ac-PSMA-617 (AAA817), given for up to 6 cycles at a dose of 10 Megabecquerel (MBq) +/- 10%, plus androgen receptor pathway inhibitor (ARPI), improves the radiographic progression free survival (rPFS) compared to investigator's choice of standard of care (SOC) (ARPI change or taxane-based chemotherapy or \[177Lu\]Lu-PSMA-617 (AAA617)) in adult participants with PSMA-positive metastatic castration resistant prostate cancer (mCRPC) treated with another ARPI as last treatment and who have not been exposed to a taxane-containing chemotherapy in the mCRPC setting nor have received any prior PSMA-targeting radioligand therapy.
Timeline
- Start
- 2025-07-01
- Primary completion
- 2028-09-29
- Completion
- 2032-11-04
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | 177Lu-PSMA-617 | Other / unclassified | — | Intravenous |
| Subject | AAA817 | Other / unclassified | 10 mbq | Intravenous |
| Subject | Abiraterone acetate | Small molecule | — | Oral |
| Comparator | Cabazitaxel | Other / unclassified | — | Intravenous |
| Comparator | Docetaxel | Small molecule | — | Intravenous |
| Subject | Enzalutamide | Other / unclassified | — | Oral |