Preoperative PSMA PET/CT As Triage for EPLND in Patients Scheduled for RALP (PrePSMA)

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

• 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