Clinical Trial · NCT06388369

Neoadjuvant Lu-PSMA Radioligand Therapy and Ipilimumab in Men With Very High-risk Prostate Cancer

Overview

A randomized, open-label Phase I/II study of neoadjuvant treatment with \[177Lu\]Lu-PSMA-617 radioligandtherapy (LuPSMA) with or without Ipilimumab in participants with very high-risk prostate cancer who are candidates for Radical Prostatectomy.

Sponsor

University Hospital, Essen

Phase

Phase 1/2

ClinicalTrials.gov

NCT06388369

Drug / Compound

PSMA-617

Isotope(s):

Target(s):

PSMA

Ligand Class: Small Molecules

Chelator: DOTA

Eligibility

Inclusion

Hemoglobin ≥ 9.0 g/dL
Platelets ≥ 100 x103/μL
Tumor tissue of both prostate biopsy and radical prostatectomy specimen available for local histology review and reference pathology by Professor Henning Reis (Department of Pathology, University Hospital Frankfurt).
Patients must be PSMA Positron Emission Tomography (PET) scan positive with a prostatic SUVmax \> 12 (PRIMARY Score: 5) .

Exclusion

Distant metastasis (clinical stage M1) on conventional imaging. Oligometastatic patients on exclusively PSMA PET imaging will not be excluded. Patients with PSA values below 20ng/ml and no evidence of nodal disease are excluded.
Other concurrent cytotoxic chemotherapy, immunotherapy, radioligand therapy, or investigational therapy
Strontium-89, Samarium-153, Rhenium-186, Rhenium- 188, Radium-223,