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

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

Trial Details

NCT ID
NCT06780670
Phase
PHASE2 / PHASE3
Sponsor
Novartis Pharmaceuticals
Status
RECRUITING
Cancer Type
Prostate Cancer
Interventions
  • Investigators choice of SoC
  • AAA817
Locations (sample)
  • Scottsdale, Arizona, United States|33.50921,-111.89903
  • Los Angeles, California, United States|34.05223,-118.24368
  • Palo Alto, California, United States|37.44188,-122.14302
  • Palo Alto, California, United States|37.44188,-122.14302
  • Santa Barbara, California, United States|34.42083,-119.69819

Key Eligibility Criteria

  • adults ≥ 18 years of age.
  • ECOG performance status of 0 to 2.
  • histopathological and/or cytological confirmation of adenocarcinoma of the prostate.
  • PSMA-positive disease as assessed by PSMA PET/CT scan using an approved PSMA imaging agent as protocol instructed,

For full eligibility, visit ClinicalTrials.gov.

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