Trial Profile

NeoPSMA: A Phase I/II, Open-label, Multi-center Study of Neoadjuvant Treatment With [177Lu]Lu-PSMA-R2 (AAA602) and [225Ac]Ac-PSMA-R2 (AAA802) in Adults With Prostate-specific Membrane Antigen (PSMA) Positive High-risk Localized Prostate Cancer (HRLPC) Prior to Radical Prostatectomy and Pelvic Lymph Node Dissection

Status: Not yet recruiting

Phase of Trial: Phase I/II

Latest Information Update: 09 Oct 2025

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At a glance

Drugs 225Ac PSMA R2 (Primary) ; Lutetium 177 PSMA R2 (Primary) ; Fluorine 18 flotufolastat; Gallium (68Ga) gozetotide; Piflufolastat F18; Radelumin
Indications Prostate cancer
Focus Adverse reactions; Therapeutic Use
Acronyms NeoPSMA
Sponsors Novartis Pharmaceuticals

19 Sep 2025 Planned initiation date changed from 27 Jun 2025 to 29 Jun 2026.
26 Mar 2025 New trial record

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