Navigation, Outcomes and Quality-of-life in Prostate Cancer Patients Undergoing PSMA-targeted Surgery
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 102
- 试验地点
- 2
- 主要终点
- To evaluate the detection rate of lymph node metastases using PSMA-targeted surgery with or without a virtual 3D model (the preoperative PSMA PET scan).
研究概览
简要总结
As part of a feasibility study, it's planned to use a 3D virtual mixed reality model with prostate cancer patients who show signs of lymph node metastasis and are scheduled for surgery. The model is based on PSMA PET imaging performed prior to surgery and will be evaluated by surgeons, the surgical team, and patients as part of the consultation process. First, the researcher investigates whether the removal of lymph node metastases has improved compared to the data in the literature . In addition, the study examines how the 3D model influences the movement of surgical instruments and the efficiency of surgical removal of lymph node metastases. To this end, the analyzed recorded video and position data of the instruments used during procedures performed with a surgical robot. It's also an aim to develop two methods-using landmarks and visual position tracking-for more targeted navigation during surgery. Additionally, short-term results examine, such as PSA response rates, as an indication of successful lymph node metastasis removal and patient quality of life.
详细描述
In this prospective feasibility study, it's planned to use a 3D virtual mixed reality model based on the preoperative PSMA PET. The model will be evaluated as an educational tool for patients and surgeons in cases of primary high-risk prostate cancer and prostate cancer recurrence with PSMA PET-positive lymph node metastasis. In general, the detection rate of PSMA-guided surgical procedures will investigate with the histological result as the reference. Furthermore, the influence of 3D visualization on the movement of surgical instruments and the efficiency of targeted resection is analyzed the help of image data from two cameras and the position data of the instruments during robot-assisted procedures. Additionally, will the investigators develop and examine two navigation methods (landmark-based registration and visual tracking) in a retrospective approach that use the preoperative PSMA PET and the image and instrument position data captured during robotic procedures. The short-term oncological outcomes (PSA response rates) will examine as an indicator of the successful removal of macroscopic PSMA-PET-positive lesions and the quality of life (QoL) of patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 78 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Patients with hormone-sensitive prostate cancer scheduled for radical prostatectomy with pelvic lymph node dissection
- •<3 PSMA-PET-avid lymph node metastases (PSMA expression score >2) in the pelvis.
- •Patients with hormone-sensitive recurrent prostate cancer after radical prostatectomy with planned pelvic salvage lymph node dissection
- •<3 PSMA-PET-avid lymph node metastases (PSMA expression score >2) in the pelvis
- •PSA value <2ng/ml.
排除标准
- •Estimated life expectancy <10 years
- •contraindication for surgical intervention
- •androgen deprivation therapy (ADT) within the last 3 months
研究组 & 干预措施
preop virtual 3D model
Cohort A: Radical prostatectomy with PSMA-targeted lymph node dissection (separate specimen) and bilateral extended pelvic lymph node dissection with additional use of a virtual 3D-model (of preoperative PSMA-PET examination) prior to surgery and postoperatively; Cohort B: Salvage lymph node dissection with PSMA-targeted lymph node dissection (separate specimen) and at least ipsilateral pelvic template lymph node dissection with additional use of a virtual 3D-model (of preoperative PSMA-PET examination) prior to surgery and postoperatively
干预措施: preop virtual 3D model (Procedure)
Control Intervention
Cohort A: Radical prostatectomy with PSMA-targeted lymph node dissection (separate specimen) and bilateral extended pelvic lymph node dissection with use of standard PSMA-PET examination prior to surgery; only postoperatively a virtual 3D-model (of preoperative PSMA-PET examination) will be evaluated; Cohort B: Salvage lymph node dissection with PSMA-targeted lymph node dissection (separate specimen) and at least ipsilateral pelvic template lymph node dissection with use of standard PSMA-PET examination prior to surgery; only postoperatively a virtual 3D-model (of preoperative PSMA-PET examination) will be evaluated
干预措施: postop 3D model (Procedure)
结局指标
主要结局
To evaluate the detection rate of lymph node metastases using PSMA-targeted surgery with or without a virtual 3D model (the preoperative PSMA PET scan).
时间窗: two weeks post surgery
The 3D model is used for surgical guidance during open/robotic primary prostatectomy with pelvic lymph node dissection (Cohort A) or open/robotic salvage lymph node dissection (SLND) for recurrent prostate cancer (Cohort B). The postoperative histology of the specifically dissected tissue serves as a reference.
次要结局
- Feasibility and accuracy of preoperative virtual 3D modeling for patient consultation and surgical planning (determined by pre- and postoperative standardized User Experience Questionnaire (UEQ) and Mixed reality Questionnaire).(six months after surgery)
- Retrospective analysis of vision-based and robotic tracking methods for target detection and retrospective analysis of the efficiency of PSMA-targeted dissection based on instrument tracking information (in robotic surgery)(six months after surgery)
- Diagnostic accuracy of PSMA-PET-CT for detection of lymph node metastases during open/robotic primary prostatectomy with pelvic lymph node dissection (Cohort A) or open/robotic salvage lymph node dissection (SLND) for recurrent prostate cancer (Cohort B)(six months after surgery)
- Short-term oncologic outcomes (complete biochemical response (cBR), defined as a PSA level <0.2 ng/mL at 8-12 weeks (Cohort A) or 4-6 weeks (Cohort B)).(three months after surgery)
- Quality of life (SF-12, EPIC-26), morbidity (intra- and postoperative complications within 6 months according to the Clavien-Dindo classification) and satisfaction (Decision Regret Scale) after surgery(six months after surgery)
研究者
Anke Renter
Studycoordinator
Martini-Klinik am UKE GmbH