Trial Profile

A Phase II, Open-label, Multi-Center, Randomized Study of Combination of Lutetium (177Lu) Vipivotide Tetraxetan (AAA617) and Androgen Receptor Pathway Inhibitor (ARPI) vs. Lutetium (177Lu) Vipivotide Tetraxetan (AAA617) in First-line Treatment of Patients With Prostate-Specific Membrane Antigen (PSMA)-Positive Progressive Metastatic Castration Resistant Prostate Cancer (mCRPC)

Status: Active, no longer recruiting

Phase of Trial: Phase II

Latest Information Update: 27 May 2026

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At a glance

Drugs Abiraterone (Primary) ; Enzalutamide (Primary) ; Lutetium (177Lu) vipivotide tetraxetan (Primary)
Indications Adenocarcinoma; Prostate cancer
Focus Adverse reactions
Acronyms PSMAndARPI
Sponsors Novartis Pharmaceuticals

01 May 2026 The protocol has been amended to change the trial focus to safety.
01 May 2026 Planned End Date changed from 9 Apr 2029 to 15 Oct 2026.
01 May 2026 Planned primary completion date changed from 9 Apr 2029 to 15 Oct 2026.

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