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临床试验/NCT06209853
NCT06209853招募中不适用

Correlation Between Prostate-Specific Antigen (PSA) Levels and Fluorine-18 Prostate-Specific Membrane Antigen Positron Emission Tomography/Computed Tomography (F-18 PSMA PET/CT) Scan Findings in Patients With Prostate Cancer

Assiut University1 个研究点 分布在 1 个国家目标入组 59 人开始时间: 2024年1月20日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
59
试验地点
1
主要终点
To correlate between PSA Levels and F-18 PSMA PET/CT Scan findings

研究概览

简要总结

It is a cross sectional study aimed to correlate between PSA Levels and F-18 PSMA PET/CT Scan findings and to evaluate the impact of PET/CT findings on the patient management

详细描述

Prostate cancer (PC) is a prevalent malignancy that occurs primarily in old males, it is the third most common with regards of mortality (1,2). prostate-specific membrane antigen (PSMA) known as glutamate carboxypeptidase II, is a transmembrane glycoprotein highly expressed in PC cells. PSMA expression tends to increase with increased pathological Gleason grade and is thought to be upregulated with the emergence of androgen independence (2).

PSMA PET/CT imaging is important for correct primary staging and for the detection of sites of biochemical recurrence.

prostate-specific antigen Liu et al., in 2022 stated that as serum PSA levels increase, the diagnostic accuracy of F-PSMA-1007 PET/CT also improves (3) Bergero et al., in 2022 evaluated the diagnostic correlation between PSA and positivity of F-18 PSMA PET/CT in patients with biochemically recurrent prostate cancer (RPC), reporting it as a very good predictor of positivity in 18F-PSMA PET/CT in patients with RPC (4).

A Meta-Analysis in 2022 found that the detection rate (DR) of the18F-PSMA-1007 PET/CT was also improved with increasing serum PSA levels (5) Another Meta-Analysis in 2019 studied the DR of F-18 PSMA PET/CT revealing that DR is related to PSA values with significant lower DR in patients with PSA<0.5 ng/mL (6)

研究设计

研究类型
Observational
观察模型
Other
时间视角
Cross Sectional

入排标准

性别
Male
接受健康志愿者

入选标准

  • Male Patients with pathologically proven prostate cancer who will be referred to nuclear medicine unit to perform F18 PSMA for different indications

排除标准

  • Undifferentiated prostate cancer.
  • Studies with motion artifacts, or those in which patient can't stay stable or calm during acquisition.
  • Severely ill patients that hinder imaging.

结局指标

主要结局

To correlate between PSA Levels and F-18 PSMA PET/CT Scan findings

时间窗: baseline

correlation between PSA Levels and F-18 PSMA PET/CT findings qualitatively \& quantitively interpreted by 2 nuclear medicine physicians. the Gleason score and findings of anatomical imaging (CT, MRI, ultrasound), will be obtained and compared/correlated with the PSMA expression/volumetric parameters as maximum standardized uptake value (SUV)

次要结局

  • To evaluate the impact of PET/CT findings on the patient management(one year)

研究者

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

Aalaa Wael Hussein

Assistant Lecturer

Assiut University

研究点 (1)

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