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%.
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
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)
Parallel
PSMA-PET/CT
DeviceIn 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).
Nomogram
Other interventionCurrent 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%
Difference in biochemical recurrence rate between groups.
Biochemical recurrence (BCR) is defined as the occurrence of measurable (\>0.2 ng/ml) prostate specific antigen (PSA), during routinely follow-up up to five years after surgery, determined at two different occasions with at least one week between them.The BCR-rate between the control group and intervention groups will be compared.
Total number of ePLNDs and PSMA PET/CTs performed and their intervention-related healthcare costs
Total number of ePLNDs and PSMA PET/CTs performed and their intervention-related healthcare costs such as consumption of operation room (OR) time, costs of complication-related interventions and associated (prolonged) hospital stay.
Incidence and types of surgical complications after RARP and ePLND
Surgical complications are graded according to the Clavien-Dindo Classification, defined as: Grade 1 = Any deviation from the normal postoperative course. Grade 2 = Requiring pharmacological treatment with drugs other than such allowed for grade I complications. Grade 3 = Requiring surgical, endoscopic or radiological intervention, not under (Grade 3a) or under general anesthesia (Grade 3b). Grade 4 = Life-threatening complication with single organ (Grade 4a) or Multiorgan dysfunction (Grade 4b). Grade 5 = Death of a patient.
Total nodes resected on ePLND and number of positive and negative nodes within and outside of the standard ePLND template
Total nodes resected on ePLND and number of positive and negative nodes within and outside of the standard ePLND template as described by the EAU guidelines.
Occurrence of pelvic lymph node metastasis and distant metastasis (visceral, bone, distant lymph nodes, pelvic lymph nodes) on PSMA-PET/CT during follow-up
Time to appearance of pelvic lymph node metastasis (N1) and distant metastasis (M1) using PSMA PET/CT
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Canisius-Wilhelmina Hospital
Lead sponsor
ZonMw: The Netherlands Organisation for Health Research and Development
Collaborator
