NCT07355504尚未招募不适用
Prostate Cancer Early Detection Using Serial MRI Examinations
University Hospital, Grenoble0 个研究点目标入组 380 人开始时间: 2026年1月12日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 380
研究概览
简要总结
The rationale of the PROCEDE trial is to explore a novel early detection strategy in which biopsy decision does not rely on one single MRI examination, but on the progression of the MRI lesion between 2 consecutive exams, with the objective of reducing the number of unnecessary biopsies, detection of non-clinically prostate cancer and, ultimately, overtreatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
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
- •Men aged over 18 years
- •Men with an estimated life expectancy of more than 10 years
- •Biopsy-naïve men
- •PSA level ≤ 20 ng/ml
- •Presence, on the first multiparametric prostate MRI, of a PIRADS 3-5 lesion confirmed by local rereading if the MRI was performed outside the center
- •MRI of sufficient quality (PI-QUAL score 2-3)
- •PIRADS 3 lesion with a PSA density <0.15 ng/ml/ml
- •No signs of extracapsular extension or seminal vesicle invasion (MRI stage T2 confirmed by local rereading if MRI performed outside the center)
- •No suspicious lymph node (confirmed by local rereading if MRI performed outside the center)
- •Patient is insured (affiliated with the national health insurance system or benefiting from such coverage)
- •Signed informed consent form
排除标准
- •Men already under surveillance for a known MRI lesion (except if the previous MRI was performed less than 6 months ago)
- •Known mutation in DNA repair genes or suggestive family history
- •PIRADS 3 lesion with PSA density < 0.15 ng/ml/ml
- •PIRADS 5 lesion with suspected extracapsular extension or seminal vesicle invasion
- •Suspicion of lymph node involvement
- •Multiparametric prostate MRI showing a PIRADS 1-2 lesion
- •Use of treatments that may modify the appearance of MRI lesions: 5-alpha reductase inhibitors, hormone therapy
- •Patient with severe renal insufficiency (GFR < 30 ml/min/1.73 m²)
- •Contraindication to gadolinium injection
- •Contraindication to prostate biopsy
- •Vulnerable persons (covered by Articles L1111-6 to L1111-8 of the French Public Health Code)
研究者
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