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临床试验/NCT04983459
NCT04983459已完成不适用

Positron Emission Tomography/Computed Tomography With Prostate Specific Membrane Antigen Ligands for Occult Biochemical Recurrence Detection in Patients With Prostate Cancer: a Single Centre Experience

University Hospital, Brest1 个研究点 分布在 1 个国家目标入组 205 人开始时间: 2018年10月1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
205
试验地点
1
主要终点
Detection rate per patient of PET-PSMA for the detection of biochemical recurrence.

研究概览

简要总结

The aim of this study is to evaluate PSMA-PET for the detection of occult biological recurrence in patients with prostatic cancer referred to the Brest University Hospital.

详细描述

In France, prostate cancer is the most common cancer in men over 50 years of age (nearly 50,000 new cases per year) and is the third leading cause of cancer-related death in men (approximately 9,000 deaths per year).

Among patients who have undergone a curative treatment strategy for localized prostate cancer, between 27% and 53% of them will have a biochemical recurrence within 10 years.

Biochemical recurrence is defined as :

  • After total prostatectomy by the persistence of a detectable PSA or the reappearance of a detectable PSA above 0.2 ng/ml after a more or less long period of undetectability.
  • After conservative treatment (radiotherapy or brachytherapy) by an increase in PSA above a threshold set at nadir +2 ng/ml Biological recurrence precedes the occurrence of symptomatic metastases by an average of 7-8 years.

Currently, after prostatectomy, when the PSA is < 1 ng/mL, no imaging test is recommended for the assessment of recurrence (grade A recommendation).

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Male
接受健康志愿者

入选标准

  • Patients aged 18 years old or older
  • Patients referred for a PSMA PET/CT for biochemical recurrence in the nuclear medicine department of Brest University Hospital

排除标准

  • Patients for whom PET-PSMA was performed for other reasons.
  • Patient's refusal to have their data used for clinical research purposes

结局指标

主要结局

Detection rate per patient of PET-PSMA for the detection of biochemical recurrence.

时间窗: 12 months

To evaluate the detection rate per patient of PET-PSMA for the detection of biochemical recurrence

次要结局

  • Detection rate per region of PSMA-PET for the detection of biochemical recurrence(12 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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