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

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.

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Key information

Conditions

Prostate Cancer Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year–80 year

Sex eligibility

Male

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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.

Exclusion criteria

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.

Treatment and study plan

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.

Primary outcomes

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

Time frame: 1 YEAR

Secondary outcomes

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

Time frame: 1 YEAR

Study contacts

Contact information is provided by the study sponsor or research team.

GIORGIO GANDAGLIA

CONTACT

[email protected]

+39 02 26438068

LUCIA DAMBROSIO

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

IRCCS San Raffaele

Other

Registry information

Official study title

Perioperative Assessment of Intraoperative Margins and Lymph Node Invasion Using High-resolution 18F-PSMA-PET-CT in Prostate Cancer: a Pilot Study

Important dates

Study start: 2026
Primary completion: 2027
Study completion: 2027
First posted: Mar 7, 2024
Registry last updated: May 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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