Prostatic Specific Membrane Antigen Reporting and Data System (PSMA-RADS) Version 1.0: Prospective Validation and Comparison to Updated Version (v2.0)
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 477
- 试验地点
- 1
- 主要终点
- Diagnostic Accuracy of PSMA-RADS v1.0 and v2.0
研究概览
简要总结
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 1.0 in detecting prostate cancer using 68Ga-PSMA-11 PET/CT imaging. The study also compared the performance of PSMA-RADS v1.0 with the updated version 2.0.
Key points:
- 477 patients with newly diagnosed, recurrent or follow up prostate cancer underwent 68Ga-PSMA-11 PET/CT imaging.
- Three radiologists independently evaluated the scans and assigned PSMA-RADS scores using v1.0, then retrospectively using v2.0.
- Diagnostic accuracy was assessed against histopathology and follow-up imaging as reference standards.
- Inter-rater agreement was evaluated using Fleiss' kappa statistic.
- The study aimed to validate the diagnostic utility of PSMA-RADS v1.0 and compare it to the updated v2.0.
详细描述
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 PET/CT scan due to weight (e.g., >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 PET/CT 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 PET/CT imaging on integrated PET/CT scanners.
- Detailed acquisition protocol is provided, including patient preparation, radiotracer dosing, low-dose CT, PET acquisition, and diagnostic contrast-enhanced CT.
Image Analysis:
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Patients with newly diagnosed prostate cancer
- •Patients with biochemical recurrence of prostate cancer
- •Ability to undergo 68Ga-PSMA-11 PET/CT imaging (e.g., no contraindications such as weight limitations, claustrophobia, inability to lie still)
- •No allergy to contrast media used for the diagnostic CT component
- •Adequate hepatic and renal function to receive the radiotracer
- •Willingness to provide informed consent for participation in the study
排除标准
- •Inability to undergo PET/CT scan due to weight (e.g., >180 kg) (n=5)
- •Claustrophobia or inability to lie still throughout the scanning duration (n=3)
- •Allergy to contrast media (n=2)
- •Hepatic impairment (n=5)
- •Renal failure (n=2)
- •Patients lost during follow-up (n=7)
结局指标
主要结局
Diagnostic Accuracy of PSMA-RADS v1.0 and v2.0
时间窗: One year
The diagnostic accuracy of PSMA-RADS version 1.0 and version 2.0 for detecting prostate cancer lesions using 68Ga-PSMA-11 PET/CT. Diagnostic accuracy will be evaluated using sensitivity, specificity, positive predictive value, and negative predictive value, calculated on a per-patient basis. Histopathological results from biopsy and/or clinical/imaging follow-up will serve as the reference standard
次要结局
- Inter-rater Agreement of PSMA-RADS v1.0 and v2.0(One year)
研究者
Mohammad Abd Alkhalik Basha
Principal Investigator
Zagazig University