Accuracy of Multi-parametric Prostate MRI and MRI-targeted, Ultrasound-navigated Prostate Fusion Biopsy in the Detection of Prostate Cancer:
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 157
- 试验地点
- 1
- 主要终点
- Gleason score (minimum 2 to maximum of 10)
研究概览
简要总结
The investigators examined whether a high PI-RADS v2 score correlates with the presence of prostate cancer. In addition, the investigator inspected whether the lesion size as determined by mpMRI correlates with the presence of prostate cancer. Furthermore, the investigators study aimed to determine the sensitivity and specificity of mpMRI with respect to prostate carcinoma detection.
详细描述
Purpose: In recent years, multiparametric Magnet Resonance Imaging (mpMRI) has been established as a diagnostic imaging technique of the prostate and its assessment standardized with the "prostate imaging - data and reporting system" (PI-RADS v2). The previously established Likert scale from 1 to 5 has been shown to reflect the increasing probability of a carcinoma. Suspicious MRI lesions can be biopsied in a targeted fashion using ultrasound navigation termed fusion biopsy. The investigators examined whether a high PI-RADS v2 score correlates with the presence of prostate cancer. In addition, the investigators inspected whether the lesion size as determined by mpMRI correlates with the presence of prostate cancer. Furthermore, the investigators study aimed to determine the sensitivity and specificity of mpMRI with respect to prostate carcinoma detection.
Materials and Methods
This prospective study includes 228 consecutive patients, which underwent a perineal MRI-TRUS-fused prostate biopsy (BiopSee®, MedCom Company) during the period of September 2015 to March 2017 at the cantonal hospital Winterthur due to a suspicious PSA value, a suspicious digital rectal examination or a known prostate cancer under active surveillance. 71 patients were excluded due to lack of PI-RADS v2 diagnosis and / or MRI performed at a different center. Targeted biopsies were performed specifically in the indicated MRI lesions and standardized over the rest of the prostate (system biopsy).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Patients with mRI-TRUS Fusion prostate biopsy
- •age > 18y
- •elevated PSA
- •suspicious DRE (digital rectal examination)
- •patients with prostate cancer under active surveillance
排除标准
- •age < 18y
- •treated prostate cancer (Radiotherapy, antiandrogens therapy, brachytherapy, HIFU).
结局指标
主要结局
Gleason score (minimum 2 to maximum of 10)
时间窗: 01.09.2015 - 30.03.2017
Histological grade of the glandular structures of prostate cancer tissue or the difference in appearance compared with a normal structure. Pattern 1 - corresponds to a well differentiated carcinoma. Pattern 2 - corresponds to a moderately differentiated carcinoma. Pattern 3 - invade the surrounding tissue or having an infiltrative pattern; corresponds to a moderately differentiated carcinoma. Pattern 4 - corresponds to a poorly differentiated carcinoma. Pattern 5 - corresponds to an anaplastic carcinoma. The pathologist then sums the pattern-number of the primary and secondary grades to obtain the final Gleason score. Gleason scores range from 2 to 10, with 2 representing the most well-differentiated tumors and 10 the least-differentiated tumors.
ISUP (International Society of Urological Pathology) Grading Group (Grade 1 to Grade 5)
时间窗: 01.09.2015 - 30.03.2017
New grading system for histological grade of the glandular structures of prostate cancer tissue or the difference in appearance compared with a normal structure Grade Group 1 (Gleason score ≤6) - Only individual discrete well-formed glands Grade Group 2 (Gleason score 3+4=7) - Predominantly well-formed glands with a lesser component of poorly-formed/fused/cribriform glands Grade Group 3 (Gleason score 4+3=7) - Predominantly poorly-formed/fused/cribriform glands with a lesser component of well-formed glands Grade Group 4 (Gleason score 8) * Only poorly-formed/fused/cribriform glands or * Predominantly well-formed glands with a lesser component lacking glands or * Predominantly lacking glands with a lesser component of well-formed glands Grade Group 5 (Gleason scores 9-10) - Lacks gland formation (or with necrosis) with or without poorly-formed/fused/cribriform glands
lesion volume (ml)
时间窗: 01.09.2015 - 30.03.2017
millilitre; size of suspected areas in prostate gland in MRI
PI-RADS v2 (Prostate Imaging Reporting and Data System Version 2) score (1 - 5)
时间窗: 01.09.2015 - 30.03.2017
Radiological grading system of prostate lesions in mpMRI The PI-RADS v2 system is designed to standardize image acquisition and reporting, and to be used by medical professionals in the initial evaluation of patients to assess the risk of clinically significant prostate cancer that may require biopsy and treatment. The scale is based on a score "Yes" or "No" for Dynamic Contrast-Enhanced (DCE) parameter, and from 1 to 5 for T2-weighted (T2W) and Diffusion-weighted imaging (DWI). The score is given for each lesion, with 1 being most probably benign and 5 being highly suspicious of malignancy: PI-RADS 1: very low (clinically significant cancer is highly unlikely to be present) PI-RADS 2: low (clinically significant cancer is unlikely to be present) PI-RADS 3: intermediate (clinically significant cancer is equivocal) PI-RADS 4: high (clinically significant cancer is likely to be present) PI-RADS 5: very high (clinically significant cancer is highly likely to be present)
Prostate specific antigen (PSA)
时间窗: 01.09.2015 - 30.03.2017
ng per ml; enzyme secreted by the prostate gland
Digital rectal examination (DRE)
时间窗: 01.09.2015 - 30.03.2017
consistence of prostate gland
Prostate specific antigen - density
时间窗: 01.09.2015 - 30.03.2017
ng per ml per ml; The relationship of the prostate specific antigen level to the size and weight (volume) of the prostate.
次要结局
未报告次要终点