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NVSNovartis PharmaceuticalsSigning up patients

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

Prostate Cancer

0Calmworry score, out of 100

No strong warning signs right now. The score counts warning signs; it is not a prediction.

Why this score

No warning signs right now. That's why the score is 0.

Score over time

Stage
Phase 2/3
Patients
443 (planned)
Started
Feb 27, 2025
Main results expected
Jun 27, 2028
Fully finished
Jul 19, 2033
Results posted
not yet

What counts as success

The trial's main goal(s), called the “primary outcome.”

  • Biochemical response rate (Phase II)

    Measured over: from date of randomization up to approximately 24 months

  • Adverse Events (AEs) and Serious Adverse Events (SAEs), and deaths - Phase II

    Measured over: from day of randomization to 30 days after End of Treatment or (last AAA817 dose date + 55 days, last dose date of SoC + 30 days), whichever is later

  • Tolerability of the proposed dose of AAA817- Phase II

    Measured over: From on-treatment period which start from the first dose of study treatment until 30 days post-last dose date for SoC and 55 days post last-dose for AAA817

  • Radiographic progression-free survival (rPFS)- Phase III

    Measured over: from date of randomization up to approximately 24 months

  • Overall survival (OS)- Phase III

    Measured over: from date of randomization up to approximately 24 months

Changes Tremor has spotted

No changes since Tremor started watching this trial.
Show details (technical version)

Score inputs

  • none

Raw record changes

  • none yet

Trial ID NCT06780670 · record last updated 2026-09-22 · checked 2026-11-09 15:47 UTC

See the official record on ClinicalTrials.gov (NCT06780670) ↗