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临床试验/NCT05958004
NCT05958004已完成不适用

Application Value of Biopsy Free Technique for Prostate Specific Antigen Grey Area Prostate Cancer Based on 18F-Prostate Specific Membrane Antigen-1007 Positron Emission Tomography/Computerized Tomography

First Affiliated Hospital Xi'an Jiaotong University1 个研究点 分布在 1 个国家目标入组 92 人开始时间: 2023年6月15日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
92
试验地点
1
主要终点
detection rate of clinical significant prostate cancer

研究概览

简要总结

The goal of this observational study is to establish an evaluation system for accurate identification of prostate cancer and clinical significant prostate cancer in patients in the PSA gray zone. The main questions it aims to answer are: proportion of men who could have avoided biopsy with positive PSMA-PET and no clinically significant cancer detected on biopsy.

Participants will: 1. undergo PSMA PET/CT and multiparametric MRI; and 2. undergo prostate biopsy

Researchers will compare the diagnostic performance of PSMA PET/CT and multiparametric MRI for prostate cancer and clinical significant prostate cancer to see if there are differences.

详细描述

Prostate Specific Antigen (PSA) is a serine protease secreted by prostate epithelial cells, which is a tumor marker of prostate cancer. At present, PSA<4 ng/ml is considered as the normal value, and PSA 4-10 ng/ml is considered as the gray value. PSA>10 ng/ml should be highly suspected of prostate cancer. Prostate biopsy is still the gold standard for the diagnosis of prostate cancer. However, as an invasive procedure, it can cause many complications such as pain, bleeding, lower urinary tract symptoms and infection. There is a growing trend to reduce unnecessary prostate biopsies.

Prostate specific membrane antigen (PSMA) is a membrane-bound enzyme that is highly expressed in more than 90% of prostate cancer lesions and has become an important target for molecular imaging of prostate cancer. In recent years, radioactive nuclide 18F labeling targeting PSMA positron emission tomography/computed tomography (PET/CT) has shown important clinical application value in prostate cancer recurrence monitoring.

The goal of this observational study is to establish an evaluation system for accurate identification of prostate cancer and clinical significant prostate cancer in patients in the PSA gray zone.

Participants will: 1. undergo PSMA PET/CT and multiparametric MRI; and 2. undergo biopsy

Researchers will compare the diagnostic performance of PSMA PET/CT and multiparametric MRI for prostate cancer and clinical significant prostate cancer to see if there are differences.

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
45 Years 至 75 Years(Adult, Older Adult)
性别
Male
接受健康志愿者

入选标准

  • PSA (4-10 ng/mL)
  • MRI and PSMA PET/CT were not contraindicated
  • Did not receive prostate-related treatment
  • There are no contraindications to biopsy

排除标准

  • Coexisting with other malignancies

结局指标

主要结局

detection rate of clinical significant prostate cancer

时间窗: about 1 year

detection rate of clinical significant prostate cancer

detection rate of prostate cancer

时间窗: about 1 year

detection rate of prostate cancer

次要结局

  • expression level of survival-related genes(about 1 year)
  • gleason score group prediction(about 1 year)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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