Actively Recruiting

Phase Not Applicable
Age: 18Years +
MALE
Healthy Volunteers
NCT06398613

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

Led by Oslo University Hospital · Updated on 2024-12-31

600

Participants Needed

1

Research Sites

296 weeks

Total Duration

On this page

Sponsors

O

Oslo University Hospital

Lead Sponsor

U

University Hospital, Akershus

Collaborating Sponsor

AI-Summary

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).

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
MALE
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Biopsy-proven adenocarcinoma of the prostate
  • Indication for ePLND combined with RALP including high-risk group (EAU) or MRI showing extra prostatic extension (Likert scale 4)
  • ISUP Grade Group 3 with at least one unfavorable risk factor: clinical stage T2b-c, 50% or more positive biopsy cores, or PSA 10-20
  • Selected cN1 patients planned for surgery
  • 18 years of age or older
  • Written informed consent provided
  • No known allergies to PSMA tracer
Not Eligible

You will not qualify if you...

  • History of previously treated active prostate cancer
  • Previous cancers (except basal cell skin carcinoma) not recurrence-free for at least 5 years
  • Unable or unwilling to undergo PSMA PET/CT, ePLND, or RALP
  • Presence of distant metastasis (cM1) on MRI imaging

AI-Screening

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Trial Site Locations

Total: 1 location

1

Oslo University Hospital

Oslo, Norway, 4950

Actively Recruiting

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Research Team

V

Viktor Berge, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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