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

Not yet recruiting

• Conditions: Prostate Cancer

• Registration Number: NCT06298838
• Lead Sponsor: IRCCS San Raffaele

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-02-20
• Study First Submitted QC: 2024-03-01
• Study First Posted: 2024-03-07
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-29
• Study Start: 2025-05
• Last Update Posted: 2025-05-01
• Primary Completion: 2026-04
• Study Completion: 2026-04

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Male
• Target Recruitment: 10

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Reporting positive lymph nodes detection rate at intraoperative imaging after 18-PSMA injection	1 YEAR