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

Recruiting now · Not applicable

Conditions studied: Prostate Cancer (Adenocarcinoma)

In brief

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.

Key facts

Study ID

NCT07129551

Run by

Martini-Klinik am UKE GmbH

People needed

102

Starts

2026-01-21

Expected to finish

2028-12-01

Last updated by the study team

2026-01-12

Who can join

Age: 18 and older, up to 78. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• Estimated life expectancy <10 years
• contraindication for surgical intervention
• androgen deprivation therapy (ADT) within the last 3 months

Where it is running

• Martini-Klinik — Hamburg, Free and Hanseatic City of Hamburg, Germany (enrolling)
• Anke Renter — Hamburg, Free and Hanseatic City of Hamburg, Germany

Full record on ClinicalTrials.gov

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