NCT02651948已完成4 期
Transperineal, MRI-guided, Prostate Biopsy: First Step to Focal Treatment of Prostate Cancer
University Hospital, Strasbourg, France2 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2015年5月1日最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 90
- 试验地点
- 2
- 主要终点
- Collection of complications and rehospitalizations by using questionnaire
研究概览
简要总结
Primary purpose:
Complications and rehospitalizations after transperineal prostate biopsy MRI-guided are reduced than transrectal prostate biopsies.
Secondary purposes:
- Patients tolerance after transperineal prostate biopsy MRI-guided is better than after transrectal prostate biopsies.
- Core of transperineal prostate biopsies are better than core of transrectal prostate biopsies
- Study of correlation between radiologic images and anatomopathologic result
- Description of needle track during the procedure
- Description of real time template saturation prostate biopsy
- Comparison of transperineal prostate biopsy relevance according to EBM
- Comparison of 1.5T MRI and 3T MRI for prostate cancer detection
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 80 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •40 to 80 years' old
- •Affiliation to French social health system
- •Signed consent
- •Prostate cancer suspicion based on prostate specific antigen (PSA) or digital rectal exam WITH abnormal MRI (Prostate Imaging Reporting and Data System score 3) AND negative transrectal prostate biopsies
- •Patient treated by active surveillance for a low risk prostate cancer (T1c or T2a, Gleason = 6, PSA < 10)
排除标准
- •Gleason > 6 prostate cancer
- •Metastatic prostate cancer
- •Contraindication to MRI
- •Contraindication to general anesthesia
- •Non-reversible hemostasis trouble
- •Inability to give consent
结局指标
主要结局
Collection of complications and rehospitalizations by using questionnaire
时间窗: 12 months
次要结局
未报告次要终点
研究者
研究点 (2)
Loading locations...
相似试验
已完成
不适用
Reduction of Prostate Biopsy MorbidityProstate CancerNCT03913039Maimonides Medical Center157
已完成
不适用
Randomized Controlled Trial of MRI Target Biopsy: Transrectal vs. TransperinealProstate CancerNCT03650153Princess Al-Johara Al-Ibrahim Cancer Research Center165
招募中
不适用
MRI-targeted Biopsy of the Prostate: Software Versus Visual Registration in the Accuracy of Prostate Cancer DetectionProstate NeoplasmProstate CancerNCT03819751Universitaire Ziekenhuizen KU Leuven96
招募中
不适用
Performance of Prostate MRI and Following Biopsy to Detect Prostate Cancer Recurrence After Focal TherapyProstate CancerNCT04773821Assistance Publique - Hôpitaux de Paris260
已完成
不适用
Infective Complications in TP Biopsy Without Antibiotic ProphylaxisProstate CancerNCT06359964Chinese University of Hong Kong1,753