Open-label Study Comparing AAA817 Versus Standard of Care in the Treatment of Previously Treated PSMA-positive mCRPC Adults Who Have Disease Progressed on or After [177Lu]Lu-PSMA Targeted Therapy

Recruiting now · Phase 2/Phase 3

Conditions studied: Prostate Cancer

In brief

This is a Phase II/III study. Patient population is adult participants with PSMA-positive mCRPC who had treatments with androgen receptor pathway inhibitor (ARPI) and taxane-based chemotherapy and progressed on or after \[177Lu\]Lu-PSMA targeted therapy. Treatment of interest: the investigational treatment is AAA817 regardless of subsequent anti-neoplastic treatment. The control treatment is investigator's choice of Standard of Care, regardless of subsequent anti-neoplastic treatment

Key facts

Study ID

NCT06780670

Run by

Novartis Pharmaceuticals

People needed

443

Starts

2025-02-27

Expected to finish

2033-07-19

Last updated by the study team

2026-05-27

Who can join

Age: 18 and older, up to 100. Sex: male. Healthy volunteers: not accepted.

You may not qualify if…

• Any investigational agents within 28 days prior to the day of randomization.
• Any 225Ac-based investigational compound used prior to the day of randomization.
• Participants with a history of CNS metastases who are neurologically unstable, symptomatic, or receiving corticosteroids for the purpose of maintaining neurologic integrity.
• Concurrent acute kidney injury (renal failure developed between 48 hours to 7 days) or chronic kidney disease (at least 3 months of ongoing renal injury)
• Baseline xerostomia ≥ Grade 2 by CTCAE v.5
• History of uncontrolled hypertension, myocardial infarction (MI), angina pectoris, or coronary artery bypass graft (CABG) within 6 months prior to ICF signature and/or clinically active significant cardiac disease
• History of lymphoproliferative disease or any known malignancy or history of malignancy of any organ system within the past 5 years (except for basal cell carcinoma or actinic keratosis that have been treated with no evidence of recurrence in the past 3 months, non-invasive malignant colon polyps that have been removed).
• Other protocol-defined inclusion/exclusion criteria may apply.

Where it is running

• VA Palo Alto Health Care System — Palo Alto, California, United States (enrolling)
• Stanford University Medical Center — Palo Alto, California, United States (enrolling)
• Sansum Clinic — Santa Barbara, California, United States (enrolling)
• Saint Johns Cancer Institute — Santa Monica, California, United States (enrolling)
• Hartford Hospital — Hartford, Connecticut, United States (enrolling)
• AdventHealth — Orlando, Florida, United States (enrolling)
• University Cancer and Blood Center LLC — Athens, Georgia, United States (enrolling)
• Emory University — Atlanta, Georgia, United States (enrolling)
• Indiana University — Indianapolis, Indiana, United States (enrolling)
• University of Kansas Hospital — Kansas City, Kansas, United States (enrolling)
• East Jefferson Hospital — Metairie, Louisiana, United States (enrolling)
• Dana Farber Cancer Institute — Boston, Massachusetts, United States (enrolling)
• Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States (enrolling)
• WA Uni School Of Med — St Louis, Missouri, United States (enrolling)
• Nebraska Cancer Specialists — Omaha, Nebraska, United States (enrolling)
• New Jersey Urology LLC — Voorhees Township, New Jersey, 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)
• Fox Chase Cancer Center — Philadelphia, Pennsylvania, United States (enrolling)
• Carolina Urologic Research Center — Myrtle Beach, South Carolina, United States (enrolling)
• Texas Oncology — Dallas, Texas, United States (enrolling)
• Urology San Antonio — San Antonio, Texas, United States (enrolling)
• Utah Intermountain Medical Center — Murray, Utah, United States (enrolling)
• VA Greater LA Healthcare System — Los Angeles, California, United States (enrolling)

Full record on ClinicalTrials.gov

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