XCancer

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

Description:

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

Government Study Link:

NCT06388369 - Click here to see study on

ClinicalTrials.gov

PSMA-617

Isotope(s):
Target(s):
  • PSMA
Ligand Class: Small Molecules
Chelator: DOTA
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,