Division of Surgery and Interventional Science, Faculty of Medical Sciences, University College London, London, UK; Department of Urology, UCLH NHS Foundation Trust, London, UK.
Division of Surgery and Interventional Science, Faculty of Medical Sciences, University College London, London, UK; Department of Urology, UCLH NHS Foundation Trust, London, UK.
Lancet. 2017 Feb 25;389(10071):815-822. doi: 10.1016/S0140-6736(16)32401-1. Epub 2017 Jan 20.
Men with high serum prostate specific antigen usually undergo transrectal ultrasound-guided prostate biopsy (TRUS-biopsy). TRUS-biopsy can cause side-effects including bleeding, pain, and infection. Multi-parametric magnetic resonance imaging (MP-MRI) used as a triage test might allow men to avoid unnecessary TRUS-biopsy and improve diagnostic accuracy.
We did this multicentre, paired-cohort, confirmatory study to test diagnostic accuracy of MP-MRI and TRUS-biopsy against a reference test (template prostate mapping biopsy [TPM-biopsy]). Men with prostate-specific antigen concentrations up to 15 ng/mL, with no previous biopsy, underwent 1·5 Tesla MP-MRI followed by both TRUS-biopsy and TPM-biopsy. The conduct and reporting of each test was done blind to other test results. Clinically significant cancer was defined as Gleason score ≥4 + 3 or a maximum cancer core length 6 mm or longer. This study is registered on ClinicalTrials.gov, NCT01292291.
Between May 17, 2012, and November 9, 2015, we enrolled 740 men, 576 of whom underwent 1·5 Tesla MP-MRI followed by both TRUS-biopsy and TPM-biopsy. On TPM-biopsy, 408 (71%) of 576 men had cancer with 230 (40%) of 576 patients clinically significant. For clinically significant cancer, MP-MRI was more sensitive (93%, 95% CI 88-96%) than TRUS-biopsy (48%, 42-55%; p<0·0001) and less specific (41%, 36-46% for MP-MRI vs 96%, 94-98% for TRUS-biopsy; p<0·0001). 44 (5·9%) of 740 patients reported serious adverse events, including 8 cases of sepsis.
Using MP-MRI to triage men might allow 27% of patients avoid a primary biopsy and diagnosis of 5% fewer clinically insignificant cancers. If subsequent TRUS-biopsies were directed by MP-MRI findings, up to 18% more cases of clinically significant cancer might be detected compared with the standard pathway of TRUS-biopsy for all. MP-MRI, used as a triage test before first prostate biopsy, could reduce unnecessary biopsies by a quarter. MP-MRI can also reduce over-diagnosis of clinically insignificant prostate cancer and improve detection of clinically significant cancer.
PROMIS is funded by the UK Government Department of Health, National Institute of Health Research-Health Technology Assessment Programme, (Project number 09/22/67). This project is also supported and partly funded by UCLH/UCL Biomedical Research Centre and The Royal Marsden and Institute for Cancer Research Biomedical Research Centre and is coordinated by the Medical Research Council Clinical Trials Unit (MRC CTU) at UCL. It is sponsored by University College London (UCL).
血清前列腺特异抗原水平较高的男性通常需要接受经直肠超声引导下前列腺活检（TRUS 活检）。TRUS 活检可能会导致出血、疼痛和感染等副作用。多参数磁共振成像（MP-MRI）作为一种分诊试验，可能使男性避免不必要的 TRUS 活检，并提高诊断准确性。
我们进行了这项多中心、配对队列、确证性研究，以测试 MP-MRI 和 TRUS 活检对参考试验（模板前列腺图谱活检 [TPM 活检]）的诊断准确性。前列腺特异抗原浓度在 15ng/mL 以下、无既往活检史的男性接受 1.5T MP-MRI 检查，随后进行 TRUS 活检和 TPM 活检。每个测试的实施和报告均对其他测试结果进行盲法处理。临床显著癌症定义为 Gleason 评分≥4+3 或最大癌核心长度≥6mm。这项研究在 ClinicalTrials.gov 上注册，编号为 NCT01292291。
2012 年 5 月 17 日至 2015 年 11 月 9 日期间，我们共纳入了 740 名男性，其中 576 名男性接受了 1.5T MP-MRI 检查，随后接受了 TRUS 活检和 TPM 活检。在 TPM 活检中，576 名男性中有 408 名（71%）患有癌症，其中 230 名（40%）患者为临床显著癌症。对于临床显著癌症，MP-MRI 的敏感性（93%，95%CI 88-96%）高于 TRUS 活检（48%，42-55%；p<0.0001），特异性较低（41%，MP-MRI 为 36-46%，TRUS 活检为 96%-98%；p<0.0001）。740 名患者中有 44 名（5.9%）报告了严重不良事件，包括 8 例脓毒症。
使用 MP-MRI 进行分诊可能使 27%的患者避免进行初次活检，并减少 5%的临床不显著癌症的诊断。如果后续的 TRUS 活检根据 MP-MRI 的结果进行，与标准的 TRUS 活检路径相比，可能会发现多达 18%的临床显著癌症。MP-MRI 可作为首次前列腺活检前的一种分诊试验，将不必要的活检减少四分之一。MP-MRI 还可以减少对临床不显著前列腺癌的过度诊断，并提高对临床显著癌症的检测率。
PROMIS 由英国卫生部、国家卫生研究院-卫生技术评估计划（项目编号 09/22/67）资助。该项目还得到了 UCLH/UCL 生物医学研究中心和皇家马斯登和癌症研究所生物医学研究中心的支持和部分资助，由 UCL 医学研究理事会临床试验单位（MRC CTU）协调。它由伦敦大学学院（UCL）赞助。
