Clinical Trial

An Open-label Study of Lutetium (177Lu) Vipivotide Tetraxetan (AAA617) in Combination With ARPI Versus AAA617 in PSMA Positive First-line mCRPC

Study acronym: PSMAndARPI
Active, Not Recruiting Phase 2
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Summary
The purpose of this study is to assess safety of combination of AAA617 (administered for 6 cycles at a dose of 7.4 GBq (200 mCi) +/- 10%) and ARPI and AAA617 alone in PSMA-positive mCRPC patients who were previously treated and progressed on ARPI in the biochemical recurrence (BCR)-non metastatic hormone sensitive prostate cancer (mHSPC), mHSPC, or non-metastatic Castration Resistant Prostate Cancer (nmCRPC) setting and have not previously received a taxane-containing regimen in the metastic castrate resistant prostate cancer (mCRPC) setting.
Protocol Amendment History 4 changes
critical Primary endpoint(s) modified 2026-05-02
notable Primary completion moved earlier: 2029-04-09 -> 2026-10-15 2026-05-02
minor Completion moved earlier: 2029-04-09 -> 2026-10-15 2026-05-02
notable Trial sites reduced: 13 -> 5 locations 2026-04-09
Trial Details
NCT Number NCT06894511
Lead Sponsor Novartis Pharmaceuticals
Conditions Metastatic Castration Resistant Prostate Cancer (mCRPC)
Enrollment 7 participants
Start Date 2025-09-11
Primary Completion 2026-10-15 (estimated)
Study Completion 2026-10-15 (estimated)
Updated on ClinicalTrials.gov 2026-05-01