Kasivisvanathan Veeru, Jichi Fatima, Klotz Laurence, Villers Arnauld, Taneja Samir S, Punwani Shonit, Freeman Alex, Emberton Mark, Moore Caroline M
Division of Surgery and Interventional Science, University College London, London, UK.
Department of Urology, University College London Hospital, London, UK.
BMJ Open. 2017 Oct 12;7(10):e017863. doi: 10.1136/bmjopen-2017-017863.
The classical pathway for the diagnosis of prostate cancer is transrectal ultrasound-guided (TRUS) biopsy of the prostate initiated on the basis of a raised prostate-specific antigen (PSA). An alternative pathway is to perform multi-parametricMRI (MPMRI) to localise cancer and to use this information to influence the decision for, and conduct of, a subsequent biopsy, known as an MPMRI-targeted biopsy. An MPMRI pathway has been shown to detect a similar or greater amount of clinically significant cancer as TRUS biopsy but has several advantages, including the potential to biopsy fewer men with fewer cores.
This is a pragmatic, international, multicentre, parallel group randomised study in which men are allocated in a 1:1 ratio to an MPMRI or TRUS biopsy pathway. This study will assess whether an MPMRI-targeted biopsy approach is non-inferior to a standard TRUS biopsy approach in the diagnosis of clinically significant cancer.Men in the MRI arm will undergo targeted biopsy of suspicious areas only and no biopsy will be carried out if the MRI is non-suspicious. Men in the TRUS biopsy will undergo a standard 10-12-core TRUS biopsy. The main inclusion criteria are a serum PSA ≤20 ng/mL, a digital rectal examination finding of T2 or less and no prior prostate biopsy.The primary outcome is the proportion of men with clinically significant cancer detected. A sample size of at least 470 patients is required. Key secondary outcomes include the proportion of clinically insignificant cancer detected.
Ethical approval was obtained from the National Research Ethics Committee East Midlands, Leicester (15/EM/0188). Results of this study will be disseminated through national and international papers. The participants and relevant patient support groups will be informed about the results of the study.
NCT02380027; Pre-results.
前列腺癌的经典诊断途径是基于前列腺特异性抗原（PSA）升高进行经直肠超声引导（TRUS）前列腺活检。另一种途径是进行多参数磁共振成像（MPMRI）以定位癌症，并利用该信息影响后续活检的决策和实施，即MPMRI靶向活检。已证明MPMRI途径与TRUS活检相比，能检测出数量相似或更多的具有临床意义的癌症，且具有多个优势，包括有可能减少活检的男性人数及穿刺针数。
这是一项务实的国际多中心平行组随机研究，男性按1:1比例分配至MPMRI或TRUS活检途径组。本研究将评估MPMRI靶向活检方法在诊断具有临床意义的癌症方面是否不劣于标准TRUS活检方法。MRI组的男性仅对可疑区域进行靶向活检，如果MRI检查无异常则不进行活检。TRUS活检组的男性将接受标准的10 - 12针TRUS活检。主要纳入标准为血清PSA≤20 ng/mL、直肠指检结果为T2或更低且既往未进行过前列腺活检。主要结局是检测出具有临床意义癌症的男性比例。所需样本量至少为470例患者。关键次要结局包括检测出无临床意义癌症的比例。
已获得东米德兰兹莱斯特国家研究伦理委员会的伦理批准（15/EM/0188）。本研究结果将通过国内和国际论文进行传播。将向参与者及相关患者支持团体通报研究结果。
NCT02380027；预结果。
