Navigation, Outcomes and Quality-of-life in Prostate Cancer Patients Undergoing PSMA-targeted Surgery
Recruiting · NCT07129551 · Interventional (participants receive a specific treatment) · Lead sponsor: Martini-Klinik am UKE GmbH
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
Inclusion criteria
- Cohort A:
- Patients with hormone-sensitive prostate cancer scheduled for radical prostatectomy with pelvic lymph node dissection
- \<3 PSMA-PET-avid lymph node metastases (PSMA expression score \>2) in the pelvis.
- Cohort B:
- Patients with hormone-sensitive recurrent prostate cancer after radical prostatectomy with planned pelvic salvage lymph node dissection
- \<3 PSMA-PET-avid lymph node metastases (PSMA expression score \>2) in the pelvis
- PSA value \<2ng/ml.
Exclusion criteria
- Estimated life expectancy \<10 years
- contraindication for surgical intervention
- androgen deprivation therapy (ADT) within the last 3 months
Where it is running
2 locations listed.
- Martini-Klinik - Hamburg, Free and Hanseatic City of Hamburg, Germany
- Anke Renter - Hamburg, Free and Hanseatic City of Hamburg, Germany