跳至主要内容
临床试验/NCT05208229
NCT05208229终止不适用

The Role of WB-MRI in the Evaluation of Prostate Cancer Patients Treated With Lu-PSMA

Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS2 个研究点 分布在 1 个国家目标入组 2 人开始时间: 2021年2月1日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
2
试验地点
2
主要终点
disease progression

研究概览

简要总结

The role of WB-MRI in the evaluation of prostate cancer patients treated with Lu-PSMA

详细描述

Multicentric, observational, single arm, prospective, study.

All patients will undergo imaging assessments according to clinical practice or to Lu-PSMA Tumor Institute of Romagna (IRST) 185.03 protocol, as follows:

  • Baseline, before the treatment with Lu-PSMA, CT and WB-MRI will be performed
  • At the end of treatment with Lu-PSMA, CT and WB-MRI will be performed
  • In post-treatment follow-up every 4 months, until progression or for 1 year, CT and WB-MRI will be performed.

Patients participating in this observational study will not be subjected to any additional procedure that falls outside the clinical practice or the study 185.03 Lu-PSMA trial at IRST.

研究设计

研究类型
Observational
观察模型
Cohort
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 mCRPC enrolled in the Tumor Institute of Romagna (IRST) 185.03 Lu-PSMA protocol, performing baseline CT and WB-MRI examinations and at least one CT and WB-MRI re-evaluation.

排除标准

  • no exclusion criteria

结局指标

主要结局

disease progression

时间窗: up to 42 months

To evaluate whether WB-MRI allows earlier identification of disease progression in comparison to CT in mCRPC patients based on imaging criteria.

次要结局

  • Reproducibility of The Metastasis (MET) Reporting And Data System (RADS) for Prostate Cancer (P) (MET - RADS - P) assessment of WB-MRI(up to 42 months)
  • response with WB-MRI compared to other assessment(up to 42 months)

研究者

研究点 (2)

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