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

NCT07272317 | Not Yet Recruiting

• 2 other identifiers: 【2025】177Y2025082
• Study Type: interventional
• Target: 98
• Locations: 1 country
• Sites: 1

Brief 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

Prostate Cancer

Outcome Measures

Primary Outcomes (1)

• Positive margin rate

  Positive margin rate (prostate radical specimens need to be stained with standard ink, and the contact between tumor cells and the ink surface of the surgical specimen is considered a positive margin; two pathologists with qualifications of associate chief physician or above (who need to have 5 years of prostate pathology diagnosis experience) blind to the patient information and independently read the films， if the two interpretations are inconsistent，the third senior pathologist (senior professional title) will review) .

  After being enrolled, the patient undergoes radical prostatectomy for prostate cancer. Around 7 to 10 days after the surgery, the pathological report will be available.

Secondary Outcomes (5)

• Nerve Preservation Success Rate, as assessed by International Index of Erectile Function-5 (IIEF-5) score and maximum urine flow rate (Qmax)

  Follow-up was conducted for 6 months after the surgery.

• Time to Urinary Continence Recovery

  Follow-up was conducted for 6 months after the surgery.

• Serum Prostate-Specific Antigen (PSA) Level

  Follow-up was conducted for 6 months after the surgery.

• Biochemical Recurrence Rate as assessed by PSA level after the surgery

  Follow-up was conducted for 6 months after the surgery.

• Number of participants with postoperative complications as assessed by the Clavien-Dindo classification system

  Follow-up was conducted for 6 months after the surgery.]

Study Arms (2)

experimental group（navigation-assisted RARP）

EXPERIMENTAL

The experimental group will use preoperative PSMA-PET/MRI and intraoperative ultrasound for multimodal fusion to construct a three-dimensional model and synchronize it in real time to the surgeon's control console through the Da Vinci surgical robot's Tilepro video integration module, and complete the anterior approach laparoscopic radical prostatectomy under this guidance.

Procedure: experimental group (navigation-assisted RARP)

Control group (traditional RARP)

NO INTERVENTION

The control group will undergo the anterior approach laparoscopic radical prostatectomy in the conventional manner.

Interventions

experimental group (navigation-assisted RARP) PROCEDURE

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.

experimental group（navigation-assisted RARP）

Eligibility Criteria

• Age: Up to 90 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (1)

Shanghai General Hospital

Shanghai, Shanghai Municipality, 200080, China

Location

Related Publications (4)

• Sivarajan G, Prabhu V, Taksler GB, Laze J, Lepor H. Ten-year outcomes of sexual function after radical prostatectomy: results of a prospective longitudinal study. Eur Urol. 2014 Jan;65(1):58-65. doi: 10.1016/j.eururo.2013.08.019. Epub 2013 Aug 26.

  PMID: 24007711 BACKGROUND

• Bakht MK, Beltran H. Biological determinants of PSMA expression, regulation and heterogeneity in prostate cancer. Nat Rev Urol. 2025 Jan;22(1):26-45. doi: 10.1038/s41585-024-00900-z. Epub 2024 Jul 8.

  PMID: 38977769 BACKGROUND

• Zhang L, Wu B, Zha Z, Zhao H, Jiang Y, Yuan J. Positive surgical margin is associated with biochemical recurrence risk following radical prostatectomy: a meta-analysis from high-quality retrospective cohort studies. World J Surg Oncol. 2018 Jul 3;16(1):124. doi: 10.1186/s12957-018-1433-3.

  PMID: 29970100 BACKGROUND

• Tewari A, Sooriakumaran P, Bloch DA, Seshadri-Kreaden U, Hebert AE, Wiklund P. Positive surgical margin and perioperative complication rates of primary surgical treatments for prostate cancer: a systematic review and meta-analysis comparing retropubic, laparoscopic, and robotic prostatectomy. Eur Urol. 2012 Jul;62(1):1-15. doi: 10.1016/j.eururo.2012.02.029. Epub 2012 Feb 24.

  PMID: 22405509 BACKGROUND

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Central Study Contacts

Cheng Liu, Doctor

CONTACT

+8618663760823; chengliumd@163.com

Jing Zhao, Doctor

CONTACT

+8618101917512; jane_zhaoj@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Physician

Model Details: This study is a single-center, prospective randomized controlled trial. The research subjects are patients with T3a or T2 (with the lesion close to the surface of the prostate) prostate cancer who underwent robot-assisted radical prostatectomy (RARP) in our hospital. The subjects were randomly divided into a control group and an experimental group. Patients in the control group received RARP according to the conventional method, while patients in the experimental group underwent preoperative PSMA-PET/MRI-ultrasound multimodal fusion and RARP under real-time navigation assistance during the operation.

Study Record Dates

• First Submitted: November 17, 2025
• First Posted: December 9, 2025
• Study Start: December 15, 2025
• Primary Completion: June 30, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: December 9, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)