PSMA PET-based 3D mixed-reality navigation for pelvic lymph node removal in prostate cancer
Navigation, Outcomes and Quality-of-life in Prostate Cancer Patients Undergoing PSMA-targeted Surgery
The trial will try using a 3D mixed-reality model made from preoperative PSMA PET scans to guide surgeons and inform patients during robot-assisted pelvic lymph node surgery for men with prostate cancer who have up to three PSMA-positive pelvic lymph nodes.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 102 (estimated) |
| Ages | 18 Years to 78 Years |
| Sex | Male |
| Sponsor | Martini-Klinik am UKE GmbH Academic / other |
| Locations | 2 sites (Hamburg, Free and Hanseatic City of Hamburg and 1 other locations) |
| Trial ID | NCT07129551 on ClinicalTrials.gov |
What this trial studies
This is a prospective feasibility project that creates a patient-specific 3D mixed-reality model from preoperative PSMA PET imaging and uses it before and after surgery as a navigation and educational tool. Surgeons, the surgical team, and patients will review the model during consultations, and robot-assisted procedures will be recorded to capture instrument position and video data. Investigators will analyze how 3D visualization affects instrument movement and the efficiency of targeted lymph node resection and will develop two navigation methods (landmark-based registration and visual tracking) using the imaging and instrument data. Short-term oncologic outcomes (PSA response) and patient quality-of-life measures will be collected to indicate successful removal of PSMA-PET-positive lesions and patient impact.
Who should consider this trial
Good fit: Men with hormone-sensitive primary high-risk prostate cancer scheduled for radical prostatectomy with pelvic lymph node dissection, or men with hormone-sensitive recurrent prostate cancer after prostatectomy scheduled for salvage pelvic lymph node dissection, who have fewer than three PSMA-PET-avid pelvic lymph nodes (PSMA score >2) and, for the recurrent group, PSA under 2 ng/ml.
Not a fit: Patients with more extensive nodal or distant metastases, more than three PSMA-positive pelvic nodes, recent androgen deprivation therapy within 3 months, contraindications to surgery, or estimated life expectancy under 10 years are unlikely to benefit from this intervention.
Why it matters
Potential benefit: If successful, the approach could improve the accuracy and efficiency of removing PSMA-PET-positive pelvic lymph nodes while helping patients understand their surgery.
How similar studies have performed: PSMA-guided and radioguided lymph node surgery have shown promise in improving detection and targeted removal, but applying 3D mixed-reality navigation and instrument-tracking methods is novel and currently being tested in feasibility work.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Hamburg, Free and Hanseatic City of Hamburg and 1 other locations
- Martini-Klinik — Hamburg, Free and Hanseatic City of Hamburg, Germany (Recruiting)
- Anke Renter — Hamburg, Free and Hanseatic City of Hamburg, Germany (Not_yet_recruiting)
Study contacts
- Study coordinator: Tobias Maurer, Professor
- Email: t.maurer@uke.de
- Phone: +4940741053115
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.