Navigation, Outcomes and Quality-of-life in Prostate Cancer Patients Undergoing PSMA-targeted Surgery

Overview

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.

Detailed description

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.

Interventions

• Procedure 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 exam
• Procedure postop 3D model
  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 exa

Primary outcome measures

• 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). [Time frame: two weeks post surgery]

Secondary outcome measures (5)

• 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). [Time frame: 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) [Time frame: 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) [Time frame: 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)). [Time frame: 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 [Time frame: six months after surgery]

Eligibility criteria

Inclusion criteria

Cohort A:

• 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.

Cohort B:

• 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.

Exclusion criteria

• Estimated life expectancy <10 years
• contraindication for surgical intervention
• androgen deprivation therapy (ADT) within the last 3 months

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

Germany · 2 centers

• Martini-Klinik — Hamburg
• Anke Renter — Hamburg

Identifiers

NCT: NCT07129551 · 2024-PS-02

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗