Tests a PSMA scan to decide on lymph node removal before prostate surgery
Tests a PSMA PET/CT scan in men with prostate cancer before surgery.
Plain-language title generated from the registry record
Registry title: Preoperative PSMA PET/CT As Triage for EPLND in Patients Scheduled for RALP (PrePSMA)
Key facts
- Where
- Oslo, NorwaySee the site
Where in Norway
- Oslo University HospitalOslo, NorwayTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Oslo University Hospital
- Trial code
- NCT06398613
- Record updated
- 31 December 2024
- Original description
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).Read full original descriptionShow less
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).
Inclusion: 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: 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.