Prostate Cancer MetastaticProstate CancerLymph Node Metastases
Investigational drug(s) / intervention(s)
PSMA-PET/CTNomogram
PSMA-PET/CT: 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).
Nomogram: 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%
Study 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
Sex
MALE
Min age
18 Years
Max age
—
Healthy volunteers
No
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)
Primary outcome measure(s)
Difference in biochemical recurrence rate between groups. — 2 years 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.
Trial sites (1)
Facility
City
Region
Status
Canisius Wilhelmina Ziekenhuis
Nijmegen
Gelderland
Recruiting
More Canisius-Wilhelmina Hospital trials in the Netherlands
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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