Clinical Trial · NCT06398613

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

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).

Sponsor

Odense University Hospital

Phase

N/A

Contacts

Viktor Berge, PhD (CONTACT)

vikber@ous-hf.no

+4791599615

Viktor Berge (PRINCIPAL_INVESTIGATOR)

ClinicalTrials.gov

NCT06398613

Drug / Compound

PSMA-11

Isotope(s):

Target(s):

PSMA

Ligand Class: Small Molecules

Chelator: HBED-CC

Eligibility

Inclusion

-ISUP GG 3 with ≥1 of the following unfavourable risk factors
cT2b-c,
* 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)

Exclusion

Presence of distant metastasis (cM1) on MRI imaging
* 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