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

NCT06298838 | Not Yet Recruiting DMC FDA Device

• 1 other identifier: XEOS study
• Study Type: observational
• Target: 10
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (1)

• To investigate the performance characteristics (sensitivity and specificity) of a novel high-resolution perioperative PET-CT-scan for intraoperative margins and lymph node invasion assessment after 18F-PSMA using histopathology as the gold standard

  1 YEAR

Secondary Outcomes (1)

• Reporting positive lymph nodes detection rate at intraoperative imaging after 18-PSMA injection

  1 YEAR

Interventions

AURA10® Specimen PET/CT imager DEVICE

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.

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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) according to the European Association of Urology (EAU) guidelines.

You may qualify if:

• Male patient, 18 years of age or older.
• Patient is confirmed with high risk prostate cancer.
• Patient is indicated to undergo radical prostatectomy and ePLND.
• Patient is estimated compliant for study participation by the investigator.
• Patient has freely given his/her informed consent to participate in this study.

You may not qualify if:

• Patient has general or local contra-indications for radical prostatectomy.
• Patient has active viral or fungal infection.
• Patient previously received radiotherapy of the prostate.
• Patient participated in other clinical studies with radiation exposure of more than 1 mSv in the past year.

Sponsors & Collaborators

• IRCCS San Raffaele: lead

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Central Study Contacts

GIORGIO GANDAGLIA

CONTACT

+39 02 26438068; gandaglia.giorgio@hsr.it

LUCIA DAMBROSIO

CONTACT

dambrosio.lucia@hsr.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: February 20, 2024
• First Posted: March 7, 2024
• Study Start: May 1, 2025
• Primary Completion: April 1, 2026
• Study Completion: April 1, 2026
• Last Updated: May 1, 2025

Record last verified: 2025-04