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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06855277 | Study Comparing AAA817+ARPI Versus Standard of Care in Adult Participants With PSMA-positive mCRPC | PHASE3 | RECRUITING | 940 | — | — | Jul 1, 2025 | Nov 4, 2032 | Jun 8, 2026 | 69 | United States, Australia +9 |
Time to radiographic disease progression or death due to any cause.
| Arm | Type | Description |
|---|---|---|
| Investigational Arm: AAA817+ARPI (enzalutamide or abiraterone) | EXPERIMENTAL | Participants will receive AAA817 infusion directly into a vein with ARPIs. |
| Investigational Arm: AAA817 | EXPERIMENTAL | Participants will receive AAA817 infusion directly into a vein. |
| Control arm: Investigator's choice of SoC (ARPI or chemotherapy or AAA617) | ACTIVE_COMPARATOR | Participants will receive standard treatment as decided by the trial doctor either as a taxane-based chemotherapy infusion directly into a vein or ARPI change either as capsules or tablets or AAA617 monotherapy infusion directly into a vein. |
| Name | Type | Description |
|---|---|---|
| AAA817 | DRUG | AAA817 is being studied for treating PSMA positive mCRPC. Inside the body, it attaches itself to PSMA on the cell surface of the prostate cancer cells and emits radiation to kill them. This treatment is also called a radioligand therapy. |
| ARPI | DRUG | Androgen receptor pathway inhibitor (ARPI): An ARPI is approved for the treatment of prostate cancer. It works by blocking signals from male hormones, such as testosterone, that helps cancer cells grow. By blocking these signals, an ARPI slows down or stops the growth of prostate cancer cells. In this trial, participants will be given either enzalutamide or abiraterone. |
| Standard of Care | DRUG | Standard treatment includes approved treatment for mCRPC. In this trial, the trial doctor will decide which available treatment participants will receive. The trial doctor will select either an ARPI of enzalutamide or abiraterone, or a taxane based chemotherapy of docetaxel or cabazitaxel or \[177Lu\]Lu-PSMA-617 (AAA617). |
Key Inclusion Criteria: * Signed informed consent must be obtained prior to participation in the study. * Participants must be adults ≥ 18 years of age. * Participants must have an ECOG performance status of 0 to 2. * Participants must have histological, and/or cytological confirmation of adenocarc...