Actively Recruiting

Phase Not Applicable
Age: 18Years - 78Years
MALE
NCT07129551

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

Led by Martini-Klinik am UKE GmbH · Updated on 2026-01-12

102

Participants Needed

2

Research Sites

149 weeks

Total Duration

On this page

AI-Summary

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 78Years
MALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Male patients aged 18 to 78 years
  • Patients with hormone-sensitive prostate cancer scheduled for radical prostatectomy with pelvic lymph node dissection (Cohort A)
  • Fewer than 3 PSMA-PET-avid lymph node metastases (PSMA expression score greater than 2) in the pelvis (Cohorts A and B)
  • Patients with hormone-sensitive recurrent prostate cancer after radical prostatectomy with planned pelvic salvage lymph node dissection (Cohort B)
  • PSA value less than 2 ng/ml (Cohort B)
Not Eligible

You will not qualify if you...

  • Estimated life expectancy less than 10 years
  • Contraindication for surgical intervention
  • Androgen deprivation therapy (ADT) within the last 3 months

AI-Screening

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Trial Site Locations

Total: 2 locations

1

Martini-Klinik

Hamburg, Free and Hanseatic City of Hamburg, Germany, 20246

Actively Recruiting

2

Anke Renter

Hamburg, Free and Hanseatic City of Hamburg, Germany, 25479

Not Yet Recruiting

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Research Team

T

Tobias Maurer, Professor

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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