Ignite Creation Date:
2025-12-24 @ 11:38 PM
Ignite Modification Date:
2025-12-31 @ 8:29 PM
Study NCT ID:
NCT07129551
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-08-19
First Post:
2025-08-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Navigation, Outcomes and Quality-of-life in Prostate Cancer Patients Undergoing PSMA-targeted Surgery
Sponsor:
Martini-Klinik am UKE GmbH
Organization:
Study Overview
Official Title:
Navigation, Outcomes and Quality-of-life in Prostate Cancer Patients Undergoing PSMA-targeted Surgery
Status:
NOT_YET_RECRUITING
Status Verified Date:
2025-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
NICE-PSMA
Brief Summary:
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.
Detailed Description:
In this prospective feasibility study, it's planned to use a 3D virtual mixed reality model based on the preoperative PSMA PET. The model will be evaluated as an educational tool for patients and surgeons in cases of primary high-risk prostate cancer and prostate cancer recurrence with PSMA PET-positive lymph node metastasis. In general, the detection rate of PSMA-guided surgical procedures will investigate with the histological result as the reference. Furthermore, the influence of 3D visualization on the movement of surgical instruments and the efficiency of targeted resection is analyzed the help of image data from two cameras and the position data of the instruments during robot-assisted procedures. Additionally, will the investigators develop and examine two navigation methods (landmark-based registration and visual tracking) in a retrospective approach that use the preoperative PSMA PET and the image and instrument position data captured during robotic procedures. The short-term oncological outcomes (PSA response rates) will examine as an indicator of the successful removal of macroscopic PSMA-PET-positive lesions and the quality of life (QoL) of patients.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: