Improving Diagnosis and Treatment of Metastatic Advanced Prostate Cancer Through Better Imaging With Whole-Body Magnetic Resonance Imaging With Diffusion Weighted Imaging
试验速览
- 阶段
- 不适用
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Single centre prospective observational imaging study
研究概览
简要总结
The aim of this study is to provide clinical evidence to determine if Whole Body Magnetic Resonance Imaging (WBMRI) with a novel technique called diffusion-weighted imaging (DWI) can improve current treatment for APC patients, allowing for early identification of disease progression or treatment response, hence facilitating clinical decision-making and leading to improvement in patient care. The IDT study includes two retrospective analyses and a single centre prospective observational study for APC patients.
详细描述
Metastatic Advanced Prostate Cancer occurs when cancer spreads from the prostate to other parts of the body (bones, lymph nodes or other organs), with bones being the commonest site of spread in prostate cancer. These cancer growths are called metastases. APC metastases are diverse (heterogeneous) in their growth pattern, such that not all metastases will respond to the same treatment.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Retrospective study A Baseline WBMRI scans in metastatic APC patients acquired up to 8 weeks prior to the initiation of a new line of therapy.
- •Retrospective study B Paired WBMRI scans in metastatic APC patients at baseline within 8 weeks prior to treatment and at 12 ± 3 weeks after systemic treatment
- •Prospective study C Written informed consent. Age ≥18 years. Advanced prostate cancer patients with indication for systemic anti-cancer therapy to be enrolled in a clinical study.
- •Participants must have a baseline WBMRI and CT-guided bone marrow biopsy.
排除标准
- •Prospective Study C Patient is claustrophobic. Contraindications to MRI examination (e.g., cardiac pacemakers, cochlear implants).
结局指标
主要结局
Single centre prospective observational imaging study
时间窗: Month 6-38
Pairwise correlations of percentage of ADC change with: 1. Tumour regression grading according to the international system of Salzer-Kuntschnik 2. Changes in biopsy tumour content and tumour/necrosis ratio 3. Fat fraction percentage with bone marrow adipose tissue/fibrosis reported by histopathology analysis.
Retrospective analysis: WBMRI parameters
时间窗: Month 1-26
Prognostic association of derived pre-treatment WBMRI parameters, total disease volume (tDV) and apparent diffusion coefficient (ADC) for prediction of overall survival.
Retrospective analysis: Diagnostic performance of MET-RADS-P
时间窗: Month 1-26
Accuracy of MET-RADS-P to assess response to systemic treatment.
次要结局
- Retrospective analysis: WBMRI parameters(Month 1-26)
- Retrospective analysis: Diagnostic performance of MET-RADS-P(Month 1-26)
- Single centre prospective observational imaging study(Month 6-38)