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

Recruiting now · Not applicable

Conditions studied: Prostate Cancer

In brief

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).

Key facts

Study ID

NCT06398613

Run by

Oslo University Hospital

People needed

600

Starts

2024-04-26

Expected to finish

2029-12-31

Last updated by the study team

2024-12-31

Who can join

Age: 18 and older. Sex: male. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Oslo University Hospital — Oslo, Norway (enrolling)

Full record on ClinicalTrials.gov

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