lymphnode invasion for prostate cancer
Conditions
Interventions
The PSMA selected indication for ePLND (intervention) is compared to the
nomogram-based indication for ePLND, which is the standard of care according to
the guideline on prostate cancer of the Europ
Sponsors
Canisius Wilhelmina Ziekenhuis
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: In order to be eligible to participate in this study, a subject must meet all of the following criteria: 1. Age >=18 years 2. Biopsy proven adenocarcinoma of the prostate 3. Indication for extended pelvic lymph node dissection (ePLND) combined with robot assisted radical prostatectomy (RARP) 4. Suitable for robot-assisted ePLND + RARP 5. Mentally competent and understanding of benefits and potential burden of the study 6. Written informed consent
Exclusion criteria
Exclusion criteria: A potential subject who meets any of the following criteria will be excluded from participation in this study: 1. History of prior diagnosed or treated PCa 2. Known concomitant malignancies (except Basal Cell Carcinoma of the skin) 3.Unwillingness or inability to undergo PSMA PET/CT and/or ePLND 4. PSMA non-avid PCa (local tumor activity) 5. Presence of distant metastasis (M1)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The main study parameter is the biochemical recurrence rate within two years after surgery, defined as a PSA > 0.2 ng/ml. | — |
Secondary
| Measure | Time frame |
|---|---|
| To determine if of PSMA PET/CT as a staging tool may also serve as a selection tool for ePLND in those men who are indicated for radical prostatectomy results in fewer ePLND procedures and therefore lower overall healthcare costs and less patient burden in terms of intervention-related complications and morbidity compared to the current standard practice of nomogram based ePLND in radical prostatectomy. . | — |
Countries
Netherlands
Outcome results
None listed