Study Comparing AAA817+ARPI Versus Standard of Care in Adult Participants With PSMA-positive mCRPC
Recruiting
Phase 3
Interventional Study
Prostate Cancer
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 – 100
- Sex
- Male
- Trial phase
- Phase 3
- Study type
- Interventional
- Purpose
- Diagnostic
- Participants needed
- 940 (estimated)
- Sponsor
- Novartis Pharmaceuticals · Industry
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About This Trial
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 ad…
Trial Locations
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Eligibility Criteria
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…
Contacts
Novartis Pharmaceuticals
+41613241111
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