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

Обзор

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.

Подробное описание

Prostate cancer, the second most prevalent malignancy in men globally, has long grappled with a core dilemma in radical surgery: balancing functional preservation against oncological efficacy. Although nerve-sparing techniques significantly improve postoperative urinary control and sexual function (with robotic surgery achieving \>80% continence recovery rates), conventional approaches relying on intraoperative visual tumor boundary assessment result in positive surgical margin (PSM) rates of 11%- 38%, increasing biochemical recurrence risk exceeding 40% \[1,2\]. For locally advanced cases, sacrificing functional structures to ensure oncological radicality leads to postoperative erectile dysfunction rates up to 95% and urinary incontinence exceeding 50% \[3\].The essence of this conflict lies in: Extended resection reduces PSM rates but damages neurovascular bundles (NVBs) governing micturition and erectile function; Limited resection preserves function yet increases PSM risk due to residual microlesions-particularly in anatomically complex zones like the prostatic apex and anterior wall, where visual localization errors typically exceed 3 mm.

Preoperative imaging limitations exacerbate this: MRI offers high anatomical resolution (0.5 mm³) but cannot track intraoperative organ deformation; PSMA-PET/CT detects micrometastases with 98% sensitivity, yet spatial registration errors between metabolic/anatomical data exceed 2 mm \[4\]. Current multimodal fusion approaches are inadequate: MRI-based fusion misses early-stage lesions due to limited tumor contrast; PSMA-PET/CT fusion suffers from metabolic-anatomical misalignment.

Thus, a navigation system enabling simultaneous subclinical lesion detection and dynamic deformation compensation is imperative to resolve the function-versus-curability dilemma.

We have adopted the following approaches to complete the construction of the intraoperative navigation system: (1) On the PET/MRI before the operation, the prostate and the lesion were delineated: at least two nuclear medicine physicians independently reviewed the images and then provided a unified report; the external contour of the prostate and the three-dimensional lesion schematic diagram of the lesion were then delineated by a urologist; (2) On the intraoperative ultrasound, the prostate was delineated: the prostate image was captured in real time by BK ultrasound and then the external contour of the prostate was delineated by a urologist; (3) The multimodal fusion of the three-dimensional lesion delineated by BK ultrasound and PSMAPET/MRI was achieved through the MIM software built into the BK ultrasound; (4) The intraoperative resection was guided by the Da Vinci Tilepro functional module. So far, 6 cases have been successfully completed and compared with 6 T3a patients randomly selected from previous conventional surgeries. Currently, due to the small sample size, although the differences in the surgical margins have not reached a statistically significant difference, a trend of difference has been demonstrated. Due to the short follow-up period, the postoperative PSA and urination conditionshave not been included in the statistical cohort.

Вмешательства

• Процедура 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 t

Первичные конечные точки

• Positive margin rate [Срок оценки: 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.]

Вторичные конечные точки (5)

• Nerve Preservation Success Rate, as assessed by International Index of Erectile Function-5 (IIEF-5) score and maximum urine flow rate (Qmax) [Срок оценки: Follow-up was conducted for 6 months after the surgery.]
• Time to Urinary Continence Recovery [Срок оценки: Follow-up was conducted for 6 months after the surgery.]
• Serum Prostate-Specific Antigen (PSA) Level [Срок оценки: Follow-up was conducted for 6 months after the surgery.]
• Biochemical Recurrence Rate as assessed by PSA level after the surgery [Срок оценки: Follow-up was conducted for 6 months after the surgery.]
• Number of participants with postoperative complications as assessed by the Clavien-Dindo classification system [Срок оценки: Follow-up was conducted for 6 months after the surgery.]]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Тройное слепое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Shanghai General Hospital — Шанхай

Публикации

• 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
• 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
• 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
• 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

Идентификаторы

NCT: NCT07272317 · 【2025】177 · Y2025082

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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