Ignite Creation Date:
2024-05-06 @ 8:21 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06359717
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-04-11
First Post:
2024-03-29
Brief Title:
Prospective Validation of PSMA-RADS
Sponsor:
Zagazig University
Organization:
Zagazig University
Study Overview
Official Title:
Prostatic Specific Membrane Antigen Reporting and Data System PSMA-RADS Version 10 Prospective Validation and Comparison to Updated Version v20
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PSMA-RADS
Brief Summary:
This is a prospective multicenter study aimed at evaluating the diagnostic accuracy and reliability of the Prostate-Specific Membrane Antigen Reporting and Data System PSMA-RADS version 10 in detecting prostate cancer using 68Ga-PSMA-11 PETCT imaging The study also compared the performance of PSMA-RADS v10 with the updated version 20
Key points
477 patients with newly diagnosed recurrent or follow up prostate cancer underwent 68Ga-PSMA-11 PETCT imaging
Three radiologists independently evaluated the scans and assigned PSMA-RADS scores using v10 then retrospectively using v20
Diagnostic accuracy was assessed against histopathology and follow-up imaging as reference standards
Inter-rater agreement was evaluated using Fleiss39 kappa statistic
The study aimed to validate the diagnostic utility of PSMA-RADS v10 and compare it to the updated v20
Key points
477 patients with newly diagnosed recurrent or follow up prostate cancer underwent 68Ga-PSMA-11 PETCT imaging
Three radiologists independently evaluated the scans and assigned PSMA-RADS scores using v10 then retrospectively using v20
Diagnostic accuracy was assessed against histopathology and follow-up imaging as reference standards
Inter-rater agreement was evaluated using Fleiss39 kappa statistic
The study aimed to validate the diagnostic utility of PSMA-RADS v10 and compare it to the updated v20
Detailed Description:
Study Design and Patient Population
Between January 2023 and August 2024 a total of 477 consecutive patients were recruited from four institutions The study cohort included patients with newly diagnosed Pca referred for initial staging patients with biochemical recurrence BCR and patients referred for follow-up Patients were excluded based on the following criteria inability to undergo PETCT scan due to weight eg 180 kg n 4 claustrophobia or inability to lie still throughout the scanning duration n 6 allergy to contrast media n 3 hepatic impairment n 9 renal failure n 3 and patients lost during follow-up n 9 This resulted in a final cohort of 443 patients 164 new diagnoses 108 BCR and 171 follow-up The flowchart of the study is illustrated in Fig 1 Once enrolled all patients underwent a 68Ga-PSMA-11 PETCT scan For each patient we determined the prostate-specific antigen PSA value Gleason score GS and disease stage according to the TNM classification molecular imaging TM miTNM as proposed by PROMISE criteria
Imaging Protocol
All patients underwent 68Ga-PSMA-11 PETCT imaging on integrated PETCT scanners
Detailed acquisition protocol is provided including patient preparation radiotracer dosing low-dose CT PET acquisition and diagnostic contrast-enhanced CT
Image Analysis
Three experienced nuclear medicine radiologists independently evaluated the anonymized PETCT images in random order blinded to clinical data
They underwent standardized training on PSMA-RADS criteria before the study
For each patient the scan was divided into 4 regions prostatebed lymph nodes bones soft tissues
Each region was assessed for uptake intensity sites relevant for metastases and CT lesion definition
Radiologists assigned PSMA-RADS categories 1-5 to each region and an overall patient score using v10 criteria
Retrospectively they re-assigned scores using the updated PSMA-RADS v20 criteria after its publication in July 2023
Reference Standard
The primary endpoint was diagnostic accuracy on a per-patient basis For newly diagnosed patients n 167 the definitive diagnosis was validated by histopathological results after biopsy Biopsies were obtained through a transrectal ultrasound TRUS guided procedure within two weeks before 68Ga-PSMA-11 PETCT imaging For patients with biochemical recurrence and patients with follow-up the final diagnosis was confirmed based on the following i Histopathological findings after biopsy n 151 patients 55 locoregional 96 lymph nodes 45 bone lesions and 42 visceral soft tissue lesions Biopsies were taken by ultrasound-guided n78 or CT-guided n73 procedure within two weeks before 68Ga-PSMA-11 PETCT imaging Two experienced pathologists evaluated all specimens and the results were obtained by consensus In patients with multiple lesions the biopsy result of one lesion was considered representative of all lesions Biopsies were performed to determine the lesion type as per the doctors request ii One year of clinical and imaging follow-up n 37 Follow-up imaging was completed every six months via 68Ga-PSMA-11 PETCT analysis It was interpreted by a panel of expert readers who were informed of the locations of the lesions described by the blinded readers at initial imaging
Statistical Analysis
Diagnostic accuracy was evaluated using a 4-fold table against the reference standard
ROC analysis was performed to determine optimal cut-offs and AUCs
Inter-rater agreement was assessed using Fleiss39 kappa statistic
Performance of PSMA-RADS v10 and v20 were compared
In summary this prospective study rigorously evaluated the diagnostic performance and reliability of PSMA-RADS v10 on a multi-center cohort using 68Ga-PSMA-11 PETCT and compared it head-to-head with the updated version 20 with thorough statistical analyses planned
Between January 2023 and August 2024 a total of 477 consecutive patients were recruited from four institutions The study cohort included patients with newly diagnosed Pca referred for initial staging patients with biochemical recurrence BCR and patients referred for follow-up Patients were excluded based on the following criteria inability to undergo PETCT scan due to weight eg 180 kg n 4 claustrophobia or inability to lie still throughout the scanning duration n 6 allergy to contrast media n 3 hepatic impairment n 9 renal failure n 3 and patients lost during follow-up n 9 This resulted in a final cohort of 443 patients 164 new diagnoses 108 BCR and 171 follow-up The flowchart of the study is illustrated in Fig 1 Once enrolled all patients underwent a 68Ga-PSMA-11 PETCT scan For each patient we determined the prostate-specific antigen PSA value Gleason score GS and disease stage according to the TNM classification molecular imaging TM miTNM as proposed by PROMISE criteria
Imaging Protocol
All patients underwent 68Ga-PSMA-11 PETCT imaging on integrated PETCT scanners
Detailed acquisition protocol is provided including patient preparation radiotracer dosing low-dose CT PET acquisition and diagnostic contrast-enhanced CT
Image Analysis
Three experienced nuclear medicine radiologists independently evaluated the anonymized PETCT images in random order blinded to clinical data
They underwent standardized training on PSMA-RADS criteria before the study
For each patient the scan was divided into 4 regions prostatebed lymph nodes bones soft tissues
Each region was assessed for uptake intensity sites relevant for metastases and CT lesion definition
Radiologists assigned PSMA-RADS categories 1-5 to each region and an overall patient score using v10 criteria
Retrospectively they re-assigned scores using the updated PSMA-RADS v20 criteria after its publication in July 2023
Reference Standard
The primary endpoint was diagnostic accuracy on a per-patient basis For newly diagnosed patients n 167 the definitive diagnosis was validated by histopathological results after biopsy Biopsies were obtained through a transrectal ultrasound TRUS guided procedure within two weeks before 68Ga-PSMA-11 PETCT imaging For patients with biochemical recurrence and patients with follow-up the final diagnosis was confirmed based on the following i Histopathological findings after biopsy n 151 patients 55 locoregional 96 lymph nodes 45 bone lesions and 42 visceral soft tissue lesions Biopsies were taken by ultrasound-guided n78 or CT-guided n73 procedure within two weeks before 68Ga-PSMA-11 PETCT imaging Two experienced pathologists evaluated all specimens and the results were obtained by consensus In patients with multiple lesions the biopsy result of one lesion was considered representative of all lesions Biopsies were performed to determine the lesion type as per the doctors request ii One year of clinical and imaging follow-up n 37 Follow-up imaging was completed every six months via 68Ga-PSMA-11 PETCT analysis It was interpreted by a panel of expert readers who were informed of the locations of the lesions described by the blinded readers at initial imaging
Statistical Analysis
Diagnostic accuracy was evaluated using a 4-fold table against the reference standard
ROC analysis was performed to determine optimal cut-offs and AUCs
Inter-rater agreement was assessed using Fleiss39 kappa statistic
Performance of PSMA-RADS v10 and v20 were compared
In summary this prospective study rigorously evaluated the diagnostic performance and reliability of PSMA-RADS v10 on a multi-center cohort using 68Ga-PSMA-11 PETCT and compared it head-to-head with the updated version 20 with thorough statistical analyses planned
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None