NCT07272317Not yet recruiting
PSMA-PET/MRI-Ultrasound Multimodal Fusion Navigation for Da Vinci Robot-Assisted Radical Prostatectomy: A Randomized Controlled Trial
Source: ClinicalTrials.gov · Last updated 9 Dec 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 98 (estimated)
- First submitted
- 17 Nov 2025
- Start date
- 15 Dec 2025
- Primary completion date
- 30 Jun 2026
- Lead sponsor
- Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
- Diseases
- Prostate cancer, Childhood cancers
- NCT number
- NCT07272317
What you commit to
- Study type: Interventional
- Planned participants: 98
- From 15 Dec 2025 to the primary completion date, 30 Jun 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- ① Metastasis (M1 stage) or lymph node metastasis (N1 stage);
- Previous pelvic radiotherapy or endocrine therapy history;
- Severe cardiopulmonary dysfunction (ASA grade ≥ III); ④ Mental illness or cognitive impairment that cannot cooperate with assessment; ⑤ Participating in other interventional clinical trials.
Who the study is looking for
- Target Population: Patients with clinical stage T3a, or T2 (with the lesion close to the surface of the prostate) scheduled for robot-assisted radical prostatectomy (RARP), who have been diagnosed with prostate cancer.
- Age 50 - 80 years old;
- Pathologically confirmed as prostate adenocarcinoma (Gleason score 6 - 10);
- PSMA-PET/MRI indicates extracapsular invasion of the lesion; ④ Signed informed consent and committed to completing follow-up.
Age in the registry: - to 90 years · Sex: Male · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Shanghai General Hospital Coordinator of this site? Confirm its status | Shanghai | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.