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
- 否
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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