Preoperative PSMA PET/CT As Triage for EPLND in Patients Scheduled for RALP (PrePSMA)
Recruiting · NCT06398613 · Interventional (participants receive a specific treatment) · Lead sponsor: Oslo University Hospital
View the official record on ClinicalTrials.gov →Interventions studied
extended pelvic lymph node dissection (ePLND)
What this trial is about
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).
Who can take part
Age range
18 Years and older
Sex
Male
Healthy volunteers
Yes - healthy volunteers may be accepted
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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
Where it is running
1 location listed.
- Oslo University Hospital - Oslo, Norway