NCT04300673

Radio Guided Lymph Node Dissection in Oligometastatic Prostate Cancer Patients

• Status: Unknown
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Radboud University Medical Center · Academic / Other
• Sex: Male
• Age: 50 Years
• Healthy volunteers: Not accepted

Summary

The study is a prospective, single arm phase I/II study. The primary aim of this study is to evaluate the feasibility of 111In-PSMA I\&T radio guided surgery in patients diagnosed with prostate cancer who are highly suspected of having one or more pelvic lymph node metastases based on pre-operative imaging. Patients with prostate cancer who have a high risk of lymph node metastases based on PSMA PET/CT and scheduled for robot-assisted PLND (with or without prostatectomy) will be recruited. Eligible patients will receive an additional ferumoxtran-10 enhanced MRI to complement pre-operative imaging. Twenty-four hours before surgery, patients will receive the radiolabelled PSMA tracer. Pelvic Lymph node dissections are carried out according to standard of care procedures. During surgery, the surgeon will be provided with a gamma-probe to detect PSMA expressing lymph nodes in vivo. Dissected samples will be systematically assessed on tracer accumulation using the gamma-probe ex vivo. After surgery, the samples will be scanned in the small animal SPECT/CT and 7T-MRI. After scanning, samples will be presented to pathologists for pathological analysis according to standard of care including staining for PSMA expression. At 3 months after surgery, patients will undergo a PSMA-PET/CT. Up until one year after surgery patients will be followed according to standard of care-guidelines by 3-monthly serum-PSA measurements.

Conditions

• Prostate Cancer
• Lymph Node Metastases

Interventions

Type	Name	Description
PROCEDURE	Radio guided surgery (RGS) using Indium-labelled PSMA	Approximately 24hours prior to surgery (PLND) patients receive a radiolabelled PSMA-tracer. During surgery, urologists will use a gamma-probe to detect PSMA-postitive tumour depostitions in pelvic lymph nodes.

Timeline

• Start date: 2020-09-01
• Primary completion: 2023-04-01
• Completion: 2023-04-01
• First posted: 2020-03-09
• Last updated: 2022-04-29

Locations

2 sites across 1 country: Netherlands