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

NCT06881823 · Status: WITHDRAWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL

Last updated 2025-12-29

No results posted yet for this study

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.

Conditions

Interventions

DRUG

AAA602

\[177\]Lu-PSMA-R2 Radiopharmaceutical solution for injection/infusion.

DRUG

AAA802

\[225\]Actinium-PSMA-R2 radiopharmaceutical solution for injection/infusion

DRUG

Gallium (68Ga) gozetotide

Radioligand Imaging compound. Provided as a kit for radiopharmaceutical preparation of gallium (68Ga) gozetotide. Solution for injection.

DRUG

Piflufolastat (18F)

Radioligand Imaging compound. Provided as a ready-to-use radiopharmaceutical.

DRUG

Flotufolastat F 18

Radioligand Imaging compound. Provided as a ready to use radiopharamceutical.

DRUG

18F-PSMA-1007

Radioligand Imaging compound. Provided as a ready to use radiopharmaceutical.

Sponsors & Collaborators

Principal Investigators

  • Novartis Pharmaceuticals · Novartis Pharmaceuticals

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
100 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-06-29
Primary Completion
2030-03-31
Completion
2033-06-01
FDA Drug
Yes

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Entities

Diseases
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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06881823 on ClinicalTrials.gov