TheranosticTrials.org

Clinical Trial · NCT05000827

Dutch National Randomized Study: PSMA-PET/CT As a Triage Tool for Pelvic Lymph Node Dissection in Prostatectomy Patients

Overview

To determine if the use of Prostate-Specific Membrane Antigen Positron Emission Computer Tomography (PSMA PET/CT) as a selection tool for performing extended lymph node dissection (ePLND) for prostate cancer (PCa) in the primary staging setting results in fewer ePLND procedures and therefore lower overall healthcare costs, lower patient burden in terms of intervention-related complications and morbidity, with comparable disease prognosis, compared to the current European Guideline-recommended standard practice which includes performing ePLND in PCa patients who are candidates for active treatment with a nomogram-calculated lymph node involvement (LNI) risk \>5%.

Sponsor

Unknown Organization

Phase

N/A

Contacts

Jean-Paul A. van Basten (PRINCIPAL_INVESTIGATOR)

Lieke Wever (CONTACT)

l.wever@antoniusziekenhuis.nl

0681806668

ClinicalTrials.gov

NCT05000827

Drug / Compound

PSMA-PET/CT agent (unspecified)

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

Eligibility

Inclusion

  • Suitable for robot-assisted ePLND and RARP
  • Indication for ePLND combined with robot assisted radical prostatectomy (RARP) (MSKCC nomogram \>5%, if not applicable when only MRI targeted biopsies are positive, the Briganti nomogram will be used)
  • * Biopsy proven adenocarcinoma of the prostate
  • Written informed consent
  • Mentally competent and understanding of benefits and potential burden of the study

Exclusion

  • Presence of distant metastasis (M1)
  • PSMA non-avid PCa (local tumor activity)
  • Known concomitant malignancies (except Basal Cell Carcinoma of the skin)
  • * History of prior diagnosed or treated PCa
  • Unwillingness or inability to undergo PSMA PET/CT and/or ePLND and RARP