prostate cancer prostate carcinoma
Conditions
Interventions
Approximately 4 hours prior to surgery ICG-99mTc-nanocolloid will be injected
transrectally under ultrasound guidance into the prostate as is routinely done
for 99mTc-nanocolloid guided sentinel nod
Sponsors
Antoni van Leeuwenhoek Ziekenhuis
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: • Histologically proven prostate cancer; • Patients are clinically node negative and metastases negative (N0, M0); • Increased risk of nodal metastases according to the Briganti nomogram (> 7%); • Scheduled for surgical (laparoscopic or robotic) prostatectomy including nodal dissection.
Exclusion criteria
Exclusion criteria: • History of iodine allergy; • Hyperthyroid or thyroidal adenoma; • Kidney insufficiency.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of positive patients (as determined following histopathological analysis of the excised nodes). | — |
Secondary
| Measure | Time frame |
|---|---|
| Collection of the below summarized information will provide us an answer to the following secondary endpoints: 1. What is the role of preoperative SPECT/CT for the identification of SNs draining from the prostate? 2. Is there a difference between ICG-99mTc-nanocolloid and free ICG in the optical identification of SNs of the prostate? | — |
Countries
Netherlands
Outcome results
None listed