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

Martini-Klinik am UKE GmbH

Status: Not yet enrolling

Conditions: Prostate Cancer (Adenocarcinoma)

Treatments: Procedure: preop virtual 3D model; Procedure: postop 3D model

Study type: Interventional

Funder types: Other

Identifiers

NCT07129551

2024-PS-02

Details and patient eligibility

About

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.

Full 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.

Enrollment: 102 estimated patients

Sex: Male

Ages: 18 to 78 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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102 participants in 2 patient groups

preop virtual 3D model

Experimental group

Description:

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

Treatment:

Procedure: preop virtual 3D model

Control Intervention

Active Comparator group

Description:

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

Treatment:

Procedure: postop 3D model