High-resolution Intra-operative PSMA PET-CT in Prostate Cancer

NCT ID: NCT06298838

Last Updated: 2025-05-01

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 10 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-05-31
• Study Completion Date: 2026-04-30

Brief Summary

This is a Single-center, diagnostic open-label prospective, pilot study in a total of 10 patients affected by Prostate cancer (PCa) with a risk of lymph node invasion (LNI) higher than 5% and candidates for a robot-assisted radical prostatectomy (RARP) with an extended pelvic lymph node dissection (ePLND) .

The aim of the trial is to evaluate the feasibility and accuracy and clinical value of a novel high-resolution perioperative PET-CT-scan for intraoperative margin and lymph node invasion assessment, after 18F-PSMA injection, using histopathology as the gold standard.

Conditions

Prostate Cancer

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

AURA10® Specimen PET/CT imager

The AURA10 PET-CT specimen imager detects and measures the electron density distribution of a specimen and the radiotracer distribution within a specimen. The function of the system is to acquire and visualize PET and CT images of a specimen, based on which a healthcare professional can rapidly verify whether the correct tissue has been resected. It can be used in any condition that requires resection surgery to visualize the resected specimen. The device is automated and semi-quantitative, i.e., qualitative regarding visualization of structure and radiotracer distribution and quantitative regarding tissue density (Hounsfield units) and radiotracer uptake in the specimen (Bq/ml). The type of specimen required is resected tissue from a patient undergoing resection surgery.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. Male patient, 18 years of age or older.

2. Patient is confirmed with high risk prostate cancer.

3. Patient is indicated to undergo radical prostatectomy and ePLND.

4. Patient is estimated compliant for study participation by the investigator.

5. Patient has freely given his/her informed consent to participate in this study.

Exclusion Criteria

1. Patient has general or local contra-indications for radical prostatectomy.

2. Patient has active viral or fungal infection.

3. Patient previously received radiotherapy of the prostate.

4. Patient participated in other clinical studies with radiation exposure of more than 1 mSv in the past year.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

IRCCS San Raffaele

OTHER

Sponsor Role: lead

Responsible Party

Giorgio Gandaglia

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

GIORGIO GANDAGLIA

Role: CONTACT

gandaglia.giorgio@hsr.it

+39 02 26438068

LUCIA DAMBROSIO

Role: CONTACT

dambrosio.lucia@hsr.it

Other Identifiers

XEOS study

Identifier Type: -

Identifier Source: org_study_id