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

NCT07272317 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 98

Last updated 2025-12-09

No results posted yet for this study

Summary

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 reduce the positive margin rate to less than 10%, increase the rate of nerve preservation by 30%, shorten the postoperative urinary control recovery time to within 2 weeks, and establish a standard process for robotic surgery navigation. This will provide a new paradigm for precise surgical treatment of prostate cancer.

Conditions

Interventions

PROCEDURE

experimental group (navigation-assisted RARP)

Before the surgery, the prostate and lesions were delineated on PET/MRI: at least two nuclear medicine physicians independently reviewed the images and provided a unified report. The experimental group had the external contour of the prostate and the three-dimensional lesion schematic diagram delineated by the urologist. A BK5000 ultrasound probe was inserted into the rectum, the probe was fixed to the surgical bed frame by the stepper, and the real-time images of the prostate were captured by the ultrasound.The multimodal fusion of the three-dimensional lesion outlined by ultrasound and PSMA-PET/MRI was achieved through the built-in MIM software. Subsequently, picture-in-picture guidance was realized through the Da Vinci Tilepro functional module, and the edge of the lesion was marked with titanium clips. After the ultrasound probe was withdrawn, the peripheral resection of the prostate, nerve preserve or not were completed under the guidance of the titanium clips.

Sponsors & Collaborators

  • Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Max Age
90 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-12-15
Primary Completion
2026-06-30
Completion
2026-12-30

Countries

  • China

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07272317 on ClinicalTrials.gov