Clinical Trial

Navigation, Outcomes and Quality-of-life in Prostate Cancer Patients Undergoing PSMA-targeted Surgery

Study acronym: NICE-PSMA
Recruiting
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Summary
As part of a feasibility study, it's planned to use a 3D virtual mixed reality model with prostate cancer patients who show signs of lymph node metastasis and are scheduled for surgery. The model is based on PSMA PET imaging performed prior to surgery and will be evaluated by surgeons, the surgical team, and patients as part of the consultation process. First, the researcher investigates whether the removal of lymph node metastases has improved compared to the data in the literature . In addition, the study examines how the 3D model influences the movement of surgical instruments and the efficiency of surgical removal of lymph node metastases. To this end, the analyzed recorded video and position data of the instruments used during procedures performed with a surgical robot. It's also an aim to develop two methods-using landmarks and visual position tracking-for more targeted navigation during surgery. Additionally, short-term results examine, such as PSA response rates, as an indication of successful lymph node metastasis removal and patient quality of life.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2025-08-14.
Status change: Not Yet Recruiting → Recruiting 2026-01-09
Trial Details
NCT Number NCT07129551
Lead Sponsor Martini-Klinik am UKE GmbH
Conditions Prostate Cancer (Adenocarcinoma)
Enrollment 102 participants
Start Date 2026-01-21
Primary Completion 2027-12 (estimated)
Study Completion 2028-12 (estimated)
Updated on ClinicalTrials.gov 2026-01-12