Evaluation of a MRI-based Prostate Cancer Screening Program
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 241
- 试验地点
- 2
- 主要终点
- Total costs of the MRI based prostate cancer screening
研究概览
简要总结
The purpose of this study is to evaluate the effort and resources (incl. costs) required to detect 20 clinically relevant prostate cancer (PCA) in a screening program based on bpMRI of the prostate.
详细描述
Informed men at risk for prostate cancer will be included into the study to undergo prostate cancer screening. According to European guidelines we will include men > 50 years of age and men >45 years of age and a family history of PCA as well as African-Americans >45 years of age. In this study, bpMRI will be used for opportunistic prostate cancer screening.
The indication for prostate biopsy is based solely on the results of bpMRI. In case of detection of lesions suspicious for prostate cancer ( PIRADS 3), targeted MRI-TRUS fusion biopsy with 3 biopsies per lesion will be performed. In case no lesions suspicious for PCA ( PIRADS 3) are detected, SB will performed if PSA exceeds 10ng/ml and/or DRE is suspicious for PCA.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 46 Years 至 75 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •well-informed men with the wish for prostate cancer screening
- •prostate biopsy naïve
- •life expectancy > 10 years
- •men > 50 years of age
- •men > 45 years of age with a family history of prostate cancer
- •African-Americans > 45 years of age
排除标准
- •prostate biopsy performed prior to study
- •life expectancy < 10 years
- •acute urinary tract infection
- •NIH-CPSI score 19 (leads to initiation of urologic diagnostics and treatment)
- •IPSS score 20 (leads to initiation of urologic diagnostics and treatment)
- •Contraindications for MRI:
- •Heart pacemaker
- •Artificial heart valves (some types are eligible)
- •Cochlea implant
- •Metallic foreign bodies/devices/implants (neuro-stimulator, pain or insulin pump, etc.)
- •Severe claustrophobia
结局指标
主要结局
Total costs of the MRI based prostate cancer screening
时间窗: 24 months
Total costs of the program
次要结局
- number of patients undergoing radiotherapy(24 months)
- number of patients undergoing chemotherapy(24 months)
- number of patients undergoing active surveillance(24 months)
- number of patients undergoing radical cystoprostatectomy(24 months)
- Comparison of costs of classical screening based on PSA and DRE(24 months)
- number of patients undergoing androgen deprivation therapy(24 months)
- Distress Thermometer Assessment(24 months)
- Number of consultations(24 months)
- Quality of Life (Qol)(24 months)
- AI Evaluation(24 months)
- Number of patients(24 months)