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

Summary

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%.

Eligibility

Inclusion Criteria:

* Biopsy proven adenocarcinoma of the prostate
* 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)
* Suitable for robot-assisted ePLND and RARP
* Mentally competent and understanding of benefits and potential burden of the study
* Written informed consent
* No known allergies for PSMA tracer.

Exclusion Criteria:

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

Conditions4

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