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PSMA-PET/MRI-Ultrasound Multimodal Fusion Navigation for Da Vinci Robot-Assisted Radical Prostatectomy: A Randomized Controlled Trial

NCT07272317 · Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine · Updated 9 Dec 2025

What is being tested
experimental group (navigation-assisted RARP)
For
Prostate Cancer
Kind of study
Tests a treatment or device on volunteers. No drug phase (a device or procedure study).
Who can join
Ages Up to 90 years. About 98 people. The full rules are on the registry page.
Where
China
When
Starts or started 15 Dec 2025, ends 30 Dec 2026. Registered 9 Dec 2025.
Results
None posted yet.

In the researchers' words

Radical prostatectomy faces the core dilemma of balancing functional preservation with tumor eradication. While nerve-sparing techniques improve urinary control, intraoperative tumor localization remains imprecise, resulting in positive surgical margin (PSM) rates of 11%-38% and elevated recurrence risk. Traditional preoperative 2D imaging fails to dynamically guide surgical boundaries. Although multimodal fusion studies (e.g., MRI or PSMA-PET/CT) attempt to address this, they struggle to achieve simultaneous precision in lesion identification and real-time spatial tracking. This study pioneers a PSMA-PET/MRI-ultrasound multimodal fusion navigation system for the Da Vinci surgical robot, leveraging three innovations: PSMA-PET/MRI dual-modality synergy for subclinical lesion detection at millimeter resolution; Non-rigid point-cloud registration algorithms to dynamically compensate for intraoperative prostate deformation, enabling 3D ultrasound-PET/MRI elastic fusion; Utilizing the telipro port of the Da Vinci surgical robot to achieve intraoperative picture-in-picture navigation, real-time localization of the tumor boundary, and precise resection as well as precise protection.This study aims to verify the safety and effectiveness of the world's first PSMA-PET/MRI-ultrasound multimodal fusion navigation system adapted for the Da Vinci surgical robot. This system is expected to…
ClinicalTrials.gov, NCT07272317

Sites

  • Shanghai General HospitalShanghai, Shanghai Municipality, China