Dutch National Randomized Study: PSMA-PET/CT As a Triage Tool for Pelvic Lymph Node Dissection in Prostatectomy Patients
Multi-institutional Evaluation of the Cost-effectiveness of PSMA-PET/CT for the Detection of Pelvic Lymph Node Invasion in Newly Diagnosed Prostate Cancer Patients
Canisius-Wilhelmina Hospital
706 participants
Jul 28, 2021
INTERVENTIONAL
Conditions
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 Criteria6
- 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 Criteria5
- 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)
Interventions
In the intervention arm patients will only undergo ePLND in addition to robot-assisted radical prostatectomy (RARP) in case of suspected LNI on PSMA PET/CT (miN1), whereas ePLND will be omitted in those without PSMA positive lymph nodes (miN0).
Current standard of care includes performing extended pelvic lymph node dissection (ePLND) in all patients with primary prostate cancer and a nomogram-based risk of LNI \>5%
Locations(1)
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NCT05000827