A Randomized Controlled Trial Comparing Bp-MRI and Mp-MRI on the Screening Accuracy for Clinically Significant Prostate Cancer Before MRI-fusion Targeted Biopsy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 370
- 试验地点
- 1
- 主要终点
- Prevalence of Clinically Significant Prostate Cancer among Men as Defined by ISUP Grade Group ≥2 in Biopsy Samples
研究概览
简要总结
3.1 Study Objectives: 3.1.1 Primary objective: The investigators aim to address these questions for Taiwan males suspicious of csPCA, with PSA range of 4-20 ng/ml by conducting a RCT trial.
3.2 Study endpoints: 3.2.1 Primary endpoint: The proportion of men with clinically significant Prostate cancer(csPCa), defined as a diagnosis of ISUP (International Society of Urogenital Pathology) Grade group ≥2 prostate cancer, in at least one biopsy core.
3.2.2 Secondary endpoints:
- The proportion of men with a diagnosis of any PCa
- The proportion of men with a diagnosis of clinically insignificant PCa, defined as ISUP grade group 1 PCa (ISUP 1 PCa)
- The proportion of men with a diagnosis of csPCa
- Only in targeted biopsy
- Only in systematic biopsy
- The proportion of csPCa of all suspicious lesions from bp-MRI and mp-MRI.
详细描述
Study intervention MRI prostate Bi-parametric and multi-parametric MRI prostates can be performed using a 3.0 Tesla scanner with a pelvic phased array coil with or without contrast. MRI findings will be reported according to PI-RADS (Prostate Imaging-Reporting and Data Systems) v2.1 recommendations. MRI will be reported by radiologists with experience in MRI prostate reporting. PI-RADS scores 3-5 will be regarded as suspicious, and targeted plus systematic biopsy will be performed.
Prostate biopsy In patients with suspicious lesion found on MRI (identified as PI-RADS score 3-5 lesions on bp-MRI or mp-MRI), biopsies will be done via trans-perineal approach under general anesthesia with 3 cores of targeted biopsy from each lesion, alone with 3 cores of systemic biopsy from right and left lobes respectively.
In those without identified suspicious lesions on MRI, a standard 12-core systematic biopsy will be performed via trans-rectal approach under local anesthesia.
All biopsies will be performed by Urologists experienced in both targeted and systemic prostate biopsy. Targeted biopsies will be done by software-assisted MRI-USG fusion registration. Peri-biopsy antibiotics are given according to our clinical guidelines.
Post-biopsy management Patients will be discharged after prostate biopsy when they can pass urine without significant gross hematuria, and clinically stable. They will be followed up in the clinic within 10 days after a biopsy to review pathology results and complications. All biopsies will be assessed by experienced Urogenital pathologists and reported according to the International Society of Urological Pathology (ISUP) consensus. The study period ends after the first clinic follow-up.
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
- 50 Years 至 90 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Men ≥50 years of age
- •Clinical suspicion of prostate cancer and indicated for prostate biopsy
- •Serum Prostate-specific antigen (PSA) between 4~20 ng/mL
- •Eligible for MRI study
- •Digital rectal examination ≤ cT2 (organ-confined cancer)
- •Able to provide written informed consent.
排除标准
- •Prior prostate biopsy in the 6 months before screening visit
- •Prior diagnosis of prostate cancer
- •Contraindicated to prostate biopsy: active urinary tract infection, failed insertion of transrectal ultrasound probe into rectum (abdominal perineal resection, anal stenosis), uncorrectable coagulopathy, antiplatelet or anticoagulant which cannot be stopped (continue low-dose aspirin before and after biopsy is permitted)
- •Contraindicated to MRI study: contrast medium allergy, claustrophobia, or other contraindications (e.g.: intra-abdominal metal foreign bodies).
- •Patients without histological results of prostate biopsies due to patient refusal for biopsy or loss of follow up before biopsy being done
- •Patients have prior treatments for prostate cancers or any kinds of hormone therapy, immunotherapy, chemotherapy, radiation therapy of the pelvic cavity.
- •Patients' withdrawal of informed consents of this study
- •Withdrawal criteria:
- •Patients could not complete the scheduled MRI examinations
- •MRI images of insufficient quality to localized csPCA or to exclude the presence of csPCA
研究组 & 干预措施
prostate cancer
Patients who are suspicious of prostate cancers with abnormal digital examination, or abnormal ultrasound and having a pre-MRI and were scheduled to receive prostate biopsy will be enrolled in this study. Patients will be randomized in a 1:1 manner to bp-MRI and mp-MRI. Patients with clinical suspicion of prostate cancer on MRI with PI-RADS (Prostate Imaging-Reporting and Data System, version 2.1)
干预措施: bp-MRI prostate (Diagnostic Test)
prostate cancer
Patients who are suspicious of prostate cancers with abnormal digital examination, or abnormal ultrasound and having a pre-MRI and were scheduled to receive prostate biopsy will be enrolled in this study. Patients will be randomized in a 1:1 manner to bp-MRI and mp-MRI. Patients with clinical suspicion of prostate cancer on MRI with PI-RADS (Prostate Imaging-Reporting and Data System, version 2.1)
干预措施: mp-MRI prostate (Diagnostic Test)
结局指标
主要结局
Prevalence of Clinically Significant Prostate Cancer among Men as Defined by ISUP Grade Group ≥2 in Biopsy Samples
时间窗: 2-3 weeks
The proportion of men with clinically significant Prostate cancer(csPCa), defined as a diagnosis of ISUP (International Society of Urogenital Pathology) Grade group ≥2 prostate cancer, in at least one biopsy core.
次要结局
- Prostate Cancer Diagnosis Rates and Specifics in Biopsy Methods(4-6 weeks)