XCancer

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

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).

Sponsor:

Odense University Hospital

Phase:

N/A

Contacts:

Viktor Berge, PhD (CONTACT)

vikber@ous-hf.no

+4791599615

Viktor Berge (PRINCIPAL_INVESTIGATOR)

Government Study Link:

NCT06398613 - Click here to see study on

ClinicalTrials.gov

PSMA-11

Isotope(s):
Target(s):
  • PSMA
Ligand Class: Small Molecules
Chelator: HBED-CC
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