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Phase Not Applicable
Age: 18Years +
MALE
Healthy Volunteers
ID06398613

Using Preoperative PSMA PETCT to Guide Pelvic Lymph Node Dissection in Men Undergoing Robotic Prostate Surgery

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

600

Participants Needed

1

Research Sites

N/A

Total Duration

AI-Summary

What this Trial Is About

Researchers are investigating whether preoperative prostate specific membrane antigen PSMA positron emission tomography PETcomputed tomography CT can safely replace extended pelvic lymph node dissection ePLND for staging in men with prostate cancer PCa undergoing robot-assisted laparoscopic radical prostatectomy RALP. This study aims to compare the outcomes between patients receiving ePLND and those who might avoid it based on PSMA PETCT results, following recent guideline changes. All eligible patients will have a PSMA PETCT scan before surgery. Participants will be randomly assigned to one of two groups Arm A will undergo RALP combined with ePLND regardless of PSMA PETCT results, while Arm B will have RALP with ePLND only if the PSMA PETCT scan shows suspicious pelvic nodes if negative, only RALP will be performed. This approach evaluates whether PSMA PETCT can guide the need for ePLND. Participants will be followed for surgical complications, persistent prostate-specific antigen PSA levels, biochemical recurrence within two years, and initiation of salvage therapy. Researchers will monitor these outcomes through follow-up visits including PSA tests and assessments of surgical recovery. The studys primary measure is the difference in biochemical recurrence rates between groups within two years after treatment initiation, with additional monitoring of safety and treatment effectiveness over time.

CONDITIONS

Brief Title

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

Research Team

V

Viktor Berge, PhD

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