Preoperative PSMA PET/CT As Triage for Extended Pelvic Lymph Node Dissection (ePLND) in Patients Scheduled for Robot-Assisted Laparoscopic Radical Prostatectomy (RALP)
Preoperative PSMA PET/CT As Triage for Extended Pelvic Lymph Node Dissection (ePLND) in Patients Scheduled for Robot-Assisted Laparoscopic Radical Prostatectomy (RALP)
Extended pelvic lymph node dissection (ePLND) is considered the gold standard for nodal staging in men with prostate cancer (PCa). The aim of this project is to determine if preoperative prostate specific membrane antigen (PSMA) positron emission tomography (PET)/computed tomograpy (CT) can safely replace ePLND as a staging method in PCa patients undergoing robot-assisted laparoscopic radical prostatectomy (RALP).
Due to the latest change in EAU guidelines in May 2024, all eligible patients will undergo PSMA PET/CT. Patients will then be randomized between RALP and ePLND (Arm A) and RALP +/- ePLND (arm B): If PSMA PET/CT detect suspicious pelvic nodes, the patient will undergo ePLND concomitant with RALP. If PSMA PET/CT is negative, only RALP will be performed .
Primary outcome measures:
Difference in biochemical recurrence (BCR) rate between arm A and arm B within 2 years after initiation of primary treatment (BCR ≥ 0.2 ng/ml).
Secondary outcome measures:
Difference between Arm A and Arm B for surgical complications, persistent PSA after RALP and initiation of salvage therapy
Inclusion Criteria:
Biopsy proven diagnosed adenocarcinoma of the prostate
Indication for ePLND combined with RALP:
High-risk group (EAU) and including MRI findings indicating extra prostatic extension (Likert scale ≥4)
-ISUP GG 3 with ≥1 of the following unfavourable risk factors
cN1 selected to surgery
Written informed consent
No known allergies for PSMA tracer
18 years and older
Exclusion Criteria:
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