A Prospective Study of the Evolution of Lesions in Repeated Biparametric Prostate Magnetic Resonance Imaging
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Evolution of MRI lesions
研究概览
简要总结
The goal of this clinical trial is to prospectively investigate the evolution of lesions in biparametric magnetic resonance imaging (bpMRI) of the prostate in men with no clinically significant prostate cancer (csPCa) in their initial biopsy. The main questions it aims to answer are:
Does lesion progression in bpMRI predict a diagnosis of csPCa in per-protocol follow-up biopsies?
What are the radiological and clinical risk factors for csPCa in per-protocol follow-up biopsies?
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
- 40 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Suspicion of a local prostate cancer
- •Patient have 1-2 PI-RADS 3-5 lesion/lesions in biparametric prostate MRI, with no ISUP 2-5 prostate cancer in an initial systematic or lesion-targeted (at least two biopsy cores per lesion) biopsy
- •Prostate biopsies can be taken via transrectal approach in an outpatient clinic
- •An estimated life expentancy exceeding 10 years
- •The patient is cooperative, fluent in Finnish and understands the significance of the study
- •The patient signs an informed consent form approved by the ethics committee.
排除标准
- •The patient had undergone prostate biopsies prior to the biopsies that led to recruitment for the current study.
- •The physician's suspicion of a locally advanced or a high risk prostate cancer. Absolute exclusion criteria are PSA >20 ng/ml or T4 staged prostate finding MRI or clinical examination
- •Seriuos infectious or non-infectious complication after initial biopsy
- •Deep immunosuppression due to organ transplant, hematologic disease, or related causes.
- •Any treatment given for prostate cancer diagnosed in initial biopsy
- •Hip prosthesis or any other object in the pelvic area that affects high-quality MRI
- •Claustrophobia or other absolute or relative contraindication for high-quality MRI
研究组 & 干预措施
Follow up arm
Follow-up MRI and biopsy
干预措施: MRI (Diagnostic Test)
结局指标
主要结局
Evolution of MRI lesions
时间窗: 3-12 months
The evolution of biparametric prostate MRI findings during follow-up, assessed by the PRECISE score (1-5) using repeated biparametric prostate MRI-scan. Higher PRECISE score is associated with a higher risk of significant prostate cancer in prostate biopsy.
Evolution of clinical factors
时间窗: 3-12 months
Assessment the effect of age (years) to the biopsy result in follow up prostate biopsy.
Biopsy result during follow up
时间窗: 3-12 months
Amount of prostate cancer and prostate cancer upgrade/downgrade in repeated systematic and lesion targeted prostate biopsy during the follow up. Prostate biopsy result will be graded using ISUP Gleason Grade Group (benign, 1-5). Higher ISUP Gleason Grade Groups score is associated with a worse oncological outcomes.
次要结局
未报告次要终点
研究者
Juha Knaapila
MD, PhD
University of Eastern Finland