Clinical Trial

Study to Assess [177Lu]Lu-PSMA-R2 (AAA602) and [225Ac]Ac-PSMA-R2 (AAA802) in Participants With PSMA-positive HRLPC

Study acronym: NeoPSMA

Withdrawn Phase 1/2

View on ClinicalTrials.gov →

Why the trial stopped

The radioligands to be evaluated showed acceptable safety but limited benefit in metastatic prostate cancer

Summary

The purpose of this trial is to learn more about the effects of AAA602 and AAA802 in men with prostate-specific membrane antigen (PSMA) positive high-risk localized prostate cancer (HRLPC) before surgery to remove the prostate and lymph nodes present in the pelvis area. Lymph nodes are small structures near the prostate that help fight infections. These lymph nodes are removed during surgery because they are a site the disease can spread to.

Protocol Amendment History 3 amendments

This ClinicalTrials.gov record has been amended 3 times since 2025-03-11; most recent amendment 2025-12-19.

Status change: Not Yet Recruiting → Withdrawn 2025-12-19

Trial Details

NCT Number	NCT06881823
Lead Sponsor	Novartis Pharmaceuticals
Conditions	Prostate Cancer
Start Date	2026-06-29
Primary Completion	2030-03-31 (estimated)
Study Completion	2033-06-01 (estimated)
Updated on ClinicalTrials.gov	2025-12-29