Developing a Multivariable Diagnostic Prediction Model for Prostate Biopsy Outcome Using Biomarkers and mpMRI as Prediction Variables in Biopsy naïve Men.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 261
- 试验地点
- 1
- 主要终点
- Detection of clinical significant cancer.
研究概览
简要总结
Current standard prostate biopsy techniques, used to definitively diagnose prostate cancer (PC), utilises an ultrasound guided biopsy approach, that offers unsatisfactory specificity and sensitivity for clinical significant PC. This often leads to harmful unnecessary biopsies. To improve the overall detection of clinical significant PC, multiparametric magnetic resonance imaging (mpMRI) has emerged as a new technique that might be useful in selecting the appropriate patient for biopsy. Nevertheless, mpMRI fail to detect cancer in some circumstances and the exact role of mpMRI is undetermined. Currently, the majority of PC is diagnosed either incidentally or by unsystematic screening with prostate specific antigen (PSA). PSA suffers from being an organ specific, but cancer unspecific serum biomarker. PSA testing may neither rule out or confirm the presence of prostate cancer. Newer biomarkers have shown promise in curbing some of this sensitivity and specificity gap, but still needs refinement.
In the present study, the investigators will use mpMRI and a new set of urine and plasma biomarkers in combination, prior to performing standard biopsies in order to develop a prediction model for the biopsy outcome. If proven successful the model would offer excellent risk stratification and possibly mitigating the need for biopsies.
详细描述
Background Prostate cancer (PC) remains a significant cause of morbidity and death among men in Denmark and the rest of the western world. Over 4,500 PC cases are diagnosed every year being the second most common malignancy among men in Denmark. With increasing life expectancy, the incidence of PC is projected to increase. Pivotal to the successful treatment of prostate cancer is establishing an early diagnosis. Localised PC is potentially curable and current curative treatment options have shown efficacy in reducing cancer related mortality.
TRUS biopsies:
Transrectal ultrasound guided prostate biopsies (TRUS biopsies) are conducted routinely for histopathological confirmation in cases of suspected PC. Indication for prostate biopsies include elevated Prostate Specific Antigen (PSA) levels or palpable tumour on digital rectal examination. TRUS biopsies is associated with morbidity in the form of infection, haematuria, rectal bleeding and discomfort. Some of these complications may require hospital admission and can be life threatening.
Current standard biopsy regimes include 10 to 14 systemic biopsy cores taken from the peripheral zone of the prostate. The majority of PC involve the posterior peripheral zone of the prostate readily available for biopsies. The remaining PC are isolated to the transition-, central- and anterior zone of the prostate which are not routinely biopsied on systemic biopsies. Thus, anteriorly located cancers may not be sampled with routine investigations and TRUS biopsies may yield false negative results. As the biopsies are taken randomly throughout the gland, significant cancers located in the peripheral zone will in some cases be missed.
Biomarkers and liquid biopsies:
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
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Able to provide informed written consent.
- •Referred for prostate biopsy.
排除标准
- •Previously diagnosed with prostate cancer.
- •Active use of anticoagulant (excluding platelet inhibitors) or other contraindication for prostate biopsies.
- •Previously undergone prostate biopsies.
- •Inability to undergo mpMRI scan (pacemaker , claustrophobia, impaired renal function, allergy towards contrast agent etc)
- •Any, previous or current, therapy for benign prostate hyperplasia including surgery or medical therapy (except alpha adrenal blockers).
- •They withdraw their consent.
研究组 & 干预措施
Standard care
Study subject will undergo sampling of plasma and urine biomarkers.
干预措施: Urine and plasma biomarkes. (Diagnostic Test)
Magnetic Resonance Imaging.
Prior to biopsies a magnetic resonance imaging scan will be performed.
干预措施: mpMRI (Diagnostic Test)
Magnetic Resonance Imaging.
Prior to biopsies a magnetic resonance imaging scan will be performed.
干预措施: Urine and plasma biomarkes. (Diagnostic Test)
结局指标
主要结局
Detection of clinical significant cancer.
时间窗: 1 month
Positive biopsies with a Gleason grade \> 7.
次要结局
- Detection rate of any cancers(1 month)
研究者
Torben Brøchner Pedersen
PhD-Student, MD
Odense University Hospital