Overview
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).
Description
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
Eligibility
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
- cT2b-c,
- ≥50% percentage of positive biopsy cores,
- PSA 10-20
- cN1 selected to surgery
- Written informed consent
- No known allergies for PSMA tracer
- 18 years and older
Exclusion Criteria:
- History of previously actively treated PCa
- Previous malignancies (except basal cell carcinoma of the skin) that has not been recurrence-free past ≥5 years
- Unwillingness or inability to undergo PSMA PET/CT and/or ePLND and RALP
- Presence of distant metastasis (cM1) on MRI imaging