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临床试验/NCT07485881
NCT07485881尚未招募不适用

18F-PSMA PET/CT Versus CT Alone in Initial Staging, Assessment of Therapy Response and Evaluation of Biochemical Recurrence in Prostatic Cancer Patients

Assiut University0 个研究点目标入组 59 人开始时间: 2026年5月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
59
主要终点
Comparing 18-F PSMA PET/CT and CT in evaluation of prostatic cancer patients

研究概览

简要总结

To compare the diagnostic performance of 18-F PSMA PET/CT and CT alone in initial staging, assessment of therapy response, as well as evaluation of biochemical recurrence of prostatic cancer patients

The main question it aims to answer is:

Does 18-F PSMA PET/CT have a superior role over CT in evaluation of prostatic cancer patients?

详细描述

Prostate cancer represents the most frequently diagnosed malignancy in men worldwide and accounts for approximately 30% of all new male cancer diagnoses in 2025, with recent data highlighting a significant 3% annual increase in incidence rates, particularly in advanced-stage disease[1]. The accurate staging and restaging of prostate cancer (PCa) are critical for determining the optimal therapeutic approach, particularly in detecting nodal or distant metastases [2]. The Gleason score and Prostate-Specific Antigen (PSA) levels serve as the foundational pillars for the clinical staging and initial risk stratification of prostate cancer. The Gleason score, which evaluates the histological architecture and cellular differentiation of prostate tissue from a biopsy, is calculated by summing the two most prevalent cancer patterns (yielding scores typically ranging from 6 to 10) [3]. Concurrently, the serum PSA level acts as a biochemical marker reflecting the overall volume and activity of the prostatic disease [3,4]. Computed Tomography (CT) has been the standard imaging modality for assessment of metastatic sites; however, it relies primarily on anatomy, such as lymph node size and shape, which often leads to low sensitivity in detecting early-stage or micrometastatic disease[5]. Recently, in response to these limitations the landscape has shifted toward molecular imaging with PSMA-targeted imaging using PET/CT which targets the Prostate-Specific Membrane Antigen (PSMA) -a protein significantly overexpressed in malignant prostate cells-allowing for the detection of lesions independent of their anatomical size [6]. Evidence suggests that PSMA PET/CT provides superior diagnostic accuracy, higher sensitivity, and better specificity compared to CT alone, often leading to a change in clinical management for a substantial percentage of patients[2,7]. Additionally, the clinical utility of 18-F PSMA PET/CT is significantly enhanced by its capacity for calculating quantitative analysis. Metrics such as the maximum Standardized Uptake Value (SUVmax), PSMA-derived tumor volume (PSMA-TV), and total lesion PSMA (TL-PSMA) provide an objective, reproducible assessment of disease burden [8]. In this study, we aim to compare the diagnostic performance of 18-F PSMA PET/CT and CT alone in staging, assessment of therapy response, as well as evaluation of biochemical recurrence

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

性别
Male
接受健康志愿者

入选标准

  • Patients with known prostate cancer referred for 18-F PSMA PET/CT study

排除标准

  • Patients with claustrophobia
  • Patients refuse to do the scan

结局指标

主要结局

Comparing 18-F PSMA PET/CT and CT in evaluation of prostatic cancer patients

时间窗: 2 years

Comparison of diagnostic performance of 18-F PSMA PET/CT and CT in staging, assessment of therapy response and evaluation of biochemical recurrence

次要结局

  • Correlation between quantitative measures and other clinical, pathological and laboratory measures(2 years)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Maram Mostafa Shafeek

Dr. Maram Mostafa

Assiut University

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