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

RecruitingNAAges 18 Years - 78 YearsMaleMartini-Klinik am UKE GmbH
NCT07129551 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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

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📋 Eligibility rules (as published)
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
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What it tests

  • preop virtual 3D model
  • postop 3D model
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Where

2 sites
Martini-Klinik
Hamburg, Germany
Anke Renter
Hamburg, Germany
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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