RIDERS: Artificial Intelligence 3D Augmented Reality Robot-Assisted-Radical- Prostatectomy v.s. no3D Intervention: a Prospective Multicenter Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Perioperative surgical oncological outcomes
研究概览
简要总结
This is a prospective randomized multicenter study aimed at comparing 3D AI-AR-RARP vs. no 3D, verifying the impact of this new technology on oncological and functional outcomes after the procedure.
详细描述
Considering that prostate cancer lesions are not identifiable during surgery, except in the case of extensive and advanced tumors, the surgeon does not have a real-time perception of the location of the tumor. The absence of clear spatial visualization can therefore lead to a positive surgical margin, particularly in tumors in the T3 stage (invasion of the prostatic capsule or seminal vesicles).
Our hypothesis is that with the help of AI 3D AR during surgery, positive surgical margins can be avoided, or at least reduced, while preserving the neurovascular bundles, with a consequent improvement not only in postoperative functional outcomes (continence and potency), but also oncological ones (less biochemical disease recovery (BCR), less need for salvage radiotherapy, lower risk of metastasis).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 99 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Signature of the written informed consent and consent to the use of personal data
- •Age > 40 years and male sex
- •Pre-operative MRI performed according to ESUR recommendations and reporting in accordance with PiRads V.2
- •Disease with evidence of bulging or radiological T3 on pre-operative MRI
- •Histological diagnosis of acinar type prostate cancer in the area highlighted on MRI
- •Absence of bulky (>3 cm), bony or visceral retroperitoneal or pelvic lymph node metastatic lesions
- •Patients eligible for radical prostatectomy + pelvic lymphadenectomy
- •ECOG PS 0-1
- •Life expectancy ≥ 5 years
- •Patients motivated to preserve erection and with pre-operative sexual activity with IIEF >17
- •Availability of the patient's pre-operative clinical data
- •Patients must be available to carry out the visits foreseen in the follow-up of the protocol and consent to data collection
排除标准
- •Special histotypes of prostate cancer
- •Patients with PSA > 100 ng/ml at diagnosis
- •Inability to perform MRI (pacemaker wearers, claustrophobia...) or MRI of inadequate quality to obtain the HA3DTM 3D reconstruction
- •Concomitant treatment with other antineoplastic drugs including investigational endocrine therapies
- •Serious uncontrolled concomitant medical condition or disease including active, uncontrolled infections
- •Patients with dementia or psychiatric illness that limit compliance with study requirements or that may prevent understanding and/or signing informed consent.
研究组 & 干预措施
3D group
in Group 3D, an intrafascial nerve-sparing (NS) technique will be performed on the side of the lesion; contralaterally an intra-, inter- or extra-fascial NS technique will be performed. After removal of the prostate, virtual images of the prostate will be projected into the lodge using AI software and will be displayed thanks to the Tile-Pro. The virtual 3D model will allow identifying the extracapsular extension of the tumor lesion, projected at the level of the preserved neurovascular bundle.
A first selective excisional biopsy at the level of the suspected ECE on the NVB will be sent for extemporaneous histological examination. Under 3D AR guidance, a second selective biopsy will then be performed on the NVB at the same level as the first, however involving a larger and thicker layer of tissue. the biopsies will be sent for extemporaneous histological examination. In case of positivity, the entire NVB will be removed
干预措施: 3D Robot-assisted laparoscopic radical prostatectomy and pelvic lymphadenectomy (Procedure)
no3D group
For the no-3D group, the intra-, inter- or extra-fascial NS technique during robotic prostatectomy will be performed according to the clinical indication.
At the end of the demolitive phase a selective biopsu was performed in a cognitive fashion accordin with the information provided by MRI images.
Reconstructive phase was performed according to our previously described total anatomical reconstruction (TAR) technique for both arms.
干预措施: 3D Robot-assisted laparoscopic radical prostatectomy and pelvic lymphadenectomy (Procedure)
结局指标
主要结局
Perioperative surgical oncological outcomes
时间窗: 12 months after surgery
Verify oncological outcomes in prostate cancer patients with evidence of bulging or extracapsular disease (ECE or rT3) on preoperative MRI, in terms of positive margin rate (PSM) following surgery
次要结局
- Micturition outcomes(5 years after surgery)
- Sexual function outcomes(5 years after surgery)
- Oncological outcomes(5 years after surgery)