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临床试验/NCT04703543
NCT04703543已完成不适用

Pilot Study Evaluating the Role of Both PSMA and 64Cu-PET/CT Total Body in Patients With Locally Relapsed Prostate Cancer

Regina Elena Cancer Institute2 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2017年6月22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
50
试验地点
2
主要终点
To calculate the detection rate of PSMA and Cu-PET/CT of relapses in patients undergoing radical prostatectomy and subsequent biochemical recurrence

研究概览

简要总结

The purpose of this study is to assess the detection rate of local relapse after radical prostatectomy with either PSMA or 64Cu-PET/CTs and whether the delineation of relapsed lesions using both methods can facilitate/change the therapeutic strategy of the radiation oncologist

详细描述

PET/TC is a diagnostic tool potentially able to detect, in a single session, both local and distant disease. However, the sensitivity of 18-F-PET/CT in the identification of relapse on the prostatic bed, varies greatly and depends on the value of PSA with which the examination is carried out, the size of the relapse in the lodge, the acquisition protocol and it is limited by the physiological hyperaccumulation of the tracer in the bladder. The sensitivity of 18F-Choline PET/TC in our hands is significantly higher than the one that is generally reported in the literature (76% with PSA values >1 ng/ml after radical prostatectomy), but still lower than the one of mpMR. PET/CT with 64Cu exceeds the limits of 18F-choline PET/TC in the study of the prostatic bed, as the tracer used (64Cu) is not excreted by urinary route and therefore does not accumulate in the bladder.

This study has the following objectives:

Primary objective: - To evaluate the detection rate of both 64Cu-PET/CT and PSMA-PET/CT of relapses in patients undergoing radical prostatectomy and subsequent biochemical recurrence;

Secondary objectives are:

  • to assess any change in radiation therapy strategy in terms of lesion delineation and dose distribution at planning.
  • to evaluate the performance of both methods (mpMR and PSMA/64Cu-PET/CT) in assessing the response to radiotherapy with or without androgen deprivation

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
18 Years 至 90 Years(Adult, Older Adult)
性别
Male
接受健康志愿者

入选标准

  • Localized prostate adenocarcinoma (M0), any PSA value, any Gleason Score
  • Previous radical surgery with subsequent undetectable PSA (<0.2 ng/ml)
  • Biochemical recurrence (two consecutive PSA values of at least 0.2 ng/ml)
  • M0 to 18F-choline PET/TC
  • Local relapse at mpMR
  • Age>18 years
  • Performance Status 0-1 according to ECOG
  • Informed written consent

排除标准

  • Detectable PSA after surgery
  • Secondary bone lesions from prostate cancer or M1
  • Hormone therapy started before staging examinations
  • Previous pelvic radiotherapy
  • Crohn's disease or ulcerative colitis (active phase)
  • Psychiatric diseases
  • Contraindication to MRI (metal prostheses, pacemakers, claustrophobia, etc.)
  • Presence of coxo-femoral implants

结局指标

主要结局

To calculate the detection rate of PSMA and Cu-PET/CT of relapses in patients undergoing radical prostatectomy and subsequent biochemical recurrence

时间窗: 60 months

Ratio between positive PSMA and Cu-PET/CT patients and the total of enrolled patients (positive MRI)

次要结局

未报告次要终点

研究者

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

Giuseppe Sanguineti

Professor

Regina Elena Cancer Institute

研究点 (2)

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