Comparison of MR/ultrasound fusion-guided biopsy with ultrasound-guided biopsy for the diagnosis of prostate cancer.

Comparison of MR/ultrasound fusion-guided biopsy with ultrasound-guided biopsy for the diagnosis of prostate cancer.
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MR/超声融合引导的活检与超声引导活检的比较,以诊断前列腺癌。

DOI:
10.1001/jama.2014.17942
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发表时间:
2015-01-27
期刊:
JAMA
影响因子:
--
通讯作者:
Pinto PA
Pinto PA
中科院分区:
其他
文献类型:
--
作者:
Siddiqui MM;Rais-Bahrami S;Turkbey B;George AK;Rothwax J;Shakir N;Okoro C;Raskolnikov D;Parnes HL;Linehan WM;Merino MJ;Simon RM;Choyke PL;Wood BJ;Pinto PA

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靶向磁共振(MR)/超声融合前列腺活检已被证明可以检测前列腺癌。单独靶向活检与标准扩展六分仪活检或两种方式结合的意义尚不清楚。评估靶向与标准活检以及2种方法联合用于诊断中高危前列腺癌。2007年至2014年在美国国家癌症研究所同时接受靶向和标准活检的1003名男性的前瞻性队列研究。患者因前列腺特异性抗原(PSA)水平升高或直肠指检结果异常而转诊,通常既往活检结果为阴性。在靶向活检和标准活检之间进行风险分类比较,并在可行时,将乳腺切除术后的全腺病理学作为“金标准”。患者接受多参数前列腺磁共振成像,以确定前列腺癌疑似区域,然后进行靶向MR/超声融合活检和同期标准活检。主要目的是比较用于检测高危前列腺癌(Gleason评分≥ 4 + 3)的靶向和标准活检方法;次要终点集中在检测低风险前列腺癌(Gleason评分3 + 3或低容量3 + 4)和活检预测前列腺切除术时全腺体病理的能力。靶向MR/超声融合活检诊断前列腺癌461例,标准活检诊断前列腺癌469例。在690名接受活检的男性(69%)中,靶向活检和标准活检之间完全一致。与标准活检相比,靶向活检诊断的高风险癌症多30%(173 vs 122例,P <0.001),低风险癌症少17%(213 vs 258例,P <0.001)。当标准活检芯与靶向方法相结合时,额外诊断出103例(22%)低风险前列腺癌(83%低风险,12%中等风险和5%高风险)。在170例乳腺切除术后全腺体病变的男性患者中,靶向活检区分低风险与中、高风险疾病的预测能力大于标准活检或两种方法的组合(曲线下面积分别为0.73、0.59和0.67;所有比较P <0.05)。在因疑似前列腺癌而接受活检的男性中,与标准扩展六分仪超声引导活检相比,靶向MR/超声融合活检与高危前列腺癌检出率增加和低危前列腺癌检出率降低相关。未来的研究将需要评估靶向活检的最终临床意义。clinicaltrials.gov
Targeted magnetic resonance (MR)/ultrasound fusion prostate biopsy has been shown to detect prostate cancer. The implications of targeted biopsy alone vs standard extended-sextant biopsy or the 2 modalities combined are not well understood. To assess targeted vs standard biopsy and the 2 approaches combined for the diagnosis of intermediate- to high-risk prostate cancer. Prospective cohort study of 1003 men undergoing both targeted and standard biopsy concurrently from 2007 through 2014 at the National Cancer Institute in the United States. Patients were referred for elevated level of prostate-specific antigen (PSA) or abnormal digital rectal examination results, often with prior negative biopsy results. Risk categorization was compared among targeted and standard biopsy and, when available, whole-gland pathology after prostatectomy as the “gold standard.” Patients underwent multiparametric prostate magnetic resonance imaging to identify regions of prostate cancer suspicion followed by targeted MR/ultrasound fusion biopsy and concurrent standard biopsy. The primary objective was to compare targeted and standard biopsy approaches for detection of high-risk prostate cancer (Gleason score ≥4 + 3); secondary end points focused on detection of low-risk prostate cancer (Gleason score 3 + 3 or low-volume 3 + 4) and the biopsy ability to predict whole-gland pathology at prostatectomy. Targeted MR/ultrasound fusion biopsy diagnosed 461 prostate cancer cases, and standard biopsy diagnosed 469 cases. There was exact agreement between targeted and standard biopsy in 690 men (69%) undergoing biopsy. Targeted biopsy diagnosed 30% more high-risk cancers vs standard biopsy (173 vs 122 cases, P < .001) and 17% fewer low-risk cancers (213 vs 258 cases, P < .001). When standard biopsy cores were combined with the targeted approach, an additional 103 cases (22%) of mostly low-risk prostate cancer were diagnosed (83% low risk, 12% intermediate risk, and 5% high risk). The predictive ability of targeted biopsy for differentiating low-risk from intermediate- and high-risk disease in 170 men with whole-gland pathology after prostatectomy was greater than that of standard biopsy or the 2 approaches combined (area under the curve, 0.73, 0.59, and 0.67, respectively; P < .05 for all comparisons). Among men undergoing biopsy for suspected prostate cancer, targeted MR/ultrasound fusion biopsy, compared with standard extended-sextant ultrasound-guided biopsy, was associated with increased detection of high-risk prostate cancer and decreased detection of low-risk prostate cancer. Future studies will be needed to assess the ultimate clinical implications of targeted biopsy. clinicaltrials.gov Identifier: NCT00102544