具有靶向活检的磁共振成像(MRI)是用于前列腺癌诊断的系统性12核心经直肠超声(TRUS)活检的有吸引力的替代方法。但尚未被广泛采用。
为了确定在检测国际泌尿外科病理学学会(GG)2级或更高级别前列腺癌方面,仅采用靶向活检的MRI是否不劣于系统的TRUS活检。
这个多中心,前瞻性随机临床试验于2017年1月至2019年11月在5个加拿大学术健康科学中心进行,数据于2020年1月至3月进行分析。参与者包括临床怀疑前列腺癌的未接受活检的男性,他们被建议接受前列腺活检。使用前列腺癌预防试验风险计算器,临床怀疑被定义为发生GG2或更大前列腺癌的5%或更大的可能性,版本2。其他标准是血清前列腺特异性抗原水平为20ng/mL或更低(转换为微克/升,乘以1)且无MRI禁忌症。
磁共振成像靶向活检(MRI-TB)仅在病变具有前列腺成像报告和数据系统(PI-RADS)时,v2.0,与12核系统TRUS活检相比,评分为3或更高。
诊断为GG2或更大癌症的男性比例。次要结果包括接受GG1前列腺癌诊断的比例;GG3或更大的癌症;没有明显的癌症但随后的MRI结果阳性和/或在2年的重复活检中检测到GG2或更大的癌症;和不良事件。
意向治疗人群包括453名患者(367[81.0%]白人,19[4.2%]加拿大非洲人,32[7.1%]亚洲人,和10[2.2%]西班牙裔)随机接受TRUS活检(226[49.9%])或MRI-TB(227[51.1%]),其中421例(93.0%)可根据方案进行评估。在接受MRI检查的221名男性中,有138名(62.4%)发现了PI-RADS评分为3或更高的病变,26人(12.1%),82(38.1%),和30(14.0%),最大PI-RADS得分分别为3、4和5。接受MRI-TB的221名男性中有83名(37%)的MRI结果阴性,避免了活检。在225例接受TRUS活检的男性中,有67例(30%)发现了GG2及以上的癌症,而在227例接受MRI-TB的患者中,有79例(35%)(绝对差异,5%,97.5%的1侧CI,-3.4%至∞;非劣效性边缘,-5%)。不良事件在MRI-TB组中较少见。在MRI组中,第1级癌症检测降低了一半以上(从22%降低到10%;风险差异,-11.6%;95%CI,-18.2%至-4.9%)。
在检测GG2或更大的癌症方面,在有前列腺癌风险的男性中,磁共振成像和选择性靶向活检不劣于初始系统活检。
ClinicalTrials.gov标识符:NCT02936258。
Magnetic resonance imaging (MRI) with targeted biopsy is an appealing alternative to systematic 12-core transrectal ultrasonography (TRUS) biopsy for prostate cancer diagnosis, but has yet to be widely adopted.
To determine whether MRI with only targeted biopsy was noninferior to systematic TRUS biopsies in the detection of International Society of Urological Pathology grade group (GG) 2 or greater prostate cancer.
This multicenter, prospective randomized clinical
trial was conducted in 5 Canadian academic health sciences centers between January 2017 and November 2019, and data were analyzed between January and March 2020. Participants included biopsy-naive men with a clinical suspicion of prostate cancer who were advised to undergo a prostate biopsy. Clinical suspicion was defined as a 5% or greater chance of GG2 or greater prostate cancer using the Prostate Cancer Prevention
Trial Risk Calculator, version 2. Additional criteria were serum prostate-specific antigen levels of 20 ng/mL or less (to convert to micrograms per liter, multiply by 1) and no contraindication to MRI.
Magnetic resonance imaging-targeted biopsy (MRI-TB) only if a lesion with a Prostate Imaging Reporting and Data System (PI-RADS), v 2.0, score of 3 or greater was identified vs 12-core systematic TRUS biopsy.
The proportion of men with a diagnosis of GG2 or greater cancer. Secondary outcomes included the proportion who received a diagnosis of GG1 prostate cancer; GG3 or greater cancer; no significant cancer but subsequent positive MRI results and/or GG2 or greater cancer detected on a repeated biopsy by 2 years; and adverse events.
The intention-to-treat population comprised 453 patients (367 [81.0%] White, 19 [4.2%] African Canadian, 32 [7.1%] Asian, and 10 [2.2%] Hispanic) who were randomized to undergo TRUS biopsy (226 [49.9%]) or MRI-TB (227 [51.1%]), of which 421 (93.0%) were evaluable per protocol. A lesion with a PI-RADS score of 3 or greater was detected in 138 of 221 men (62.4%) who underwent MRI, with 26 (12.1%), 82 (38.1%), and 30 (14.0%) having maximum PI-RADS scores of 3, 4, and 5, respectively. Eighty-three of 221 men who underwent MRI-TB (37%) had a negative MRI result and avoided biopsy. Cancers GG2 and greater were identified in 67 of 225 men (30%) who underwent TRUS biopsy vs 79 of 227 (35%) allocated to MRI-TB (absolute difference, 5%, 97.5% 1-sided CI, -3.4% to ∞; noninferiority margin, -5%). Adverse events were less common in the MRI-TB arm. Grade group 1 cancer detection was reduced by more than half in the MRI arm (from 22% to 10%; risk difference, -11.6%; 95% CI, -18.2% to -4.9%).
Magnetic resonance imaging followed by selected targeted biopsy is noninferior to initial systematic biopsy in men at risk for prostate cancer in detecting GG2 or greater cancers.
ClinicalTrials.gov Identifier: NCT02936258.