Study Comparing AAA817+ARPI Versus Standard of Care in Adult Participants With PSMA-positive mCRPC
Recruiting now · Phase 3
Conditions studied: Prostate Cancer
In brief
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.
Key facts
- Study ID
- NCT06855277
- Run by
- Novartis Pharmaceuticals
- People needed
- 940
- Starts
- 2025-07-01
- Expected to finish
- 2032-11-04
- Last updated by the study team
- 2026-07-24
Who can join
Age: 18 and older, up to 100. Sex: male. Healthy volunteers: not accepted.
Where it is running
- Stanford University Medical Center — Palo Alto, California, United States (enrolling)
- Sansum Clinic — Santa Barbara, California, United States (enrolling)
- Rocky Mountain Cancer Centers — Denver, Colorado, United States (enrolling)
- Florida Cancer Specialists — Fort Myers, Florida, United States (enrolling)
- Baptist Health South — Miami, Florida, United States (enrolling)
- AdventHealth — Orlando, Florida, United States (enrolling)
- University Cancer and Blood Center LLC — Athens, Georgia, United States (enrolling)
- Northwestern University — Chicago, Illinois, United States (enrolling)
- Univ Of Iowa Hospitals And Clinics — Iowa City, Iowa, United States (enrolling)
- University of Kansas Hospital — Kansas City, Kansas, United States (enrolling)
- East Jefferson Hospital — Metairie, Louisiana, United States (enrolling)
- Beth Israel Deaconess Med Center — Boston, Massachusetts, United States (enrolling)
- Dana Farber Cancer Institute — Boston, Massachusetts, United States (enrolling)
- Karmanos Cancer Institute — Detroit, Michigan, United States (enrolling)
- Wash U School of Medicine — St Louis, Missouri, United States (enrolling)
- Nebraska Cancer Specialists — Omaha, Nebraska, United States (enrolling)
- Astera Cancer Center — East Brunswick, New Jersey, United States (enrolling)
- New Jersey Urology LLC — Voorhees Township, New Jersey, United States (enrolling)
- Bassett Medical Center — Cooperstown, New York, United States (enrolling)
- Weill Cornell Medicine NY-Presb — New York, New York, United States (enrolling)
- University of Rochester Medical Ctr — Rochester, New York, United States (enrolling)
- Associated Med Professionals of NY — Syracuse, New York, United States (enrolling)
- Montefiore Medical Center — The Bronx, New York, United States (enrolling)
- Central Ohio Urology Group — Gahanna, Ohio, United States (enrolling)
- Urology Centers Of Alabama Pc — Homewood, Alabama, United States (enrolling)
Full record on ClinicalTrials.gov
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