Division of Urology, University of Turin, San Luigi Gonzaga Hospital, Orbassano, Turin, Italy.
Division of Urology, University of Turin, San Luigi Gonzaga Hospital, Orbassano, Turin, Italy.
Eur Urol. 2017 Aug;72(2):282-288. doi: 10.1016/j.eururo.2016.08.041. Epub 2016 Aug 27.
BACKGROUND: An approach based on multiparametric magnetic resonance imaging (mpMRI) might increase the detection rate (DR) of clinically significant prostate cancer (csPCa). OBJECTIVE: To compare an mpMRI-based pathway with the standard approach for the detection of prostate cancer (PCa) and csPCa. DESIGN, SETTING, AND PARTICIPANTS: Between November 2014 and April 2016, 212 biopsy-naïve patients with suspected PCa (prostate specific antigen level ≤15 ng/ml and negative digital rectal examination results) were included in this randomized clinical trial. Patients were randomized into a prebiopsy mpMRI group (arm A, n=107) or a standard biopsy (SB) group (arm B, n=105). INTERVENTION: In arm A, patients with mpMRI evidence of lesions suspected for PCa underwent mpMRI/transrectal ultrasound fusion software-guided targeted biopsy (TB) (n=81). The remaining patients in arm A (n=26) with negative mpMRI results and patients in arm B underwent 12-core SB. OUTCOMES MEASUREMENTS AND STATISTICAL ANALYSIS: The primary end point was comparison of the DR of PCa and csPCa between the two arms of the study; the secondary end point was comparison of the DR between TB and SB. RESULTS AND LIMITATIONS: The overall DRs were higher in arm A versus arm B for PCa (50.5% vs 29.5%, respectively; p=0.002) and csPCa (43.9% vs 18.1%, respectively; p<0.001). Concerning the biopsy approach, that is, TB in arm A, SB in arm A, and SB in arm B, the overall DRs were significantly different for PCa (60.5% vs 19.2% vs 29.5%, respectively; p<0.001) and for csPCa (56.8% vs 3.8% vs 18.1%, respectively; p<0.001). The reproducibility of the study could have been affected by the single-center nature. CONCLUSIONS: A diagnostic pathway based on mpMRI had a higher DR than the standard pathway in both PCa and csPCa. PATIENT SUMMARY: In this randomized trial, a pathway for the diagnosis of prostate cancer based on multiparametric magnetic resonance imaging (mpMRI) was compared with the standard pathway based on random biopsy. The mpMRI-based pathway had better performance than the standard pathway.
背景：基于多参数磁共振成像（mpMRI）的方法可能会提高临床显著前列腺癌（csPCa）的检出率（DR）。
目的：比较基于 mpMRI 的方法与标准方法检测前列腺癌（PCa）和 csPCa 的效果。
设计、地点和参与者：2014 年 11 月至 2016 年 4 月期间，212 名疑似患有 PCa 的初诊活检患者（前列腺特异性抗原水平≤15ng/ml 且直肠指检结果阴性）参与了这项随机临床试验。患者被随机分为活检前 mpMRI 组（A 组，n=107）或标准活检（SB）组（B 组，n=105）。
干预：在 A 组中，mpMRI 显示有可疑 PCa 病灶的患者行 mpMRI/经直肠超声融合软件引导的靶向活检（TB）（n=81）。A 组中剩余的 mpMRI 结果阴性且接受 SB 的患者（n=26）和 B 组患者均行 12 针 SB。
结局测量和统计学分析：主要终点是比较研究中两组的 PCa 和 csPCa 检出率；次要终点是比较 TB 和 SB 的检出率。
结果和局限性：A 组的总体 PCa 和 csPCa 检出率均高于 B 组（分别为 50.5%和 43.9% vs 29.5%和 18.1%；p=0.002 和 p<0.001）。就活检方法而言，A 组为 TB，A 组和 B 组为 SB，PCa 和 csPCa 的总体检出率差异有统计学意义（分别为 60.5%和 56.8% vs 29.5%和 18.1%；p<0.001）。由于该研究为单中心性质，可能会影响研究的可重复性。
结论：基于 mpMRI 的诊断途径在 PCa 和 csPCa 中的检出率均高于标准途径。
患者概况：在这项随机试验中，基于多参数磁共振成像（mpMRI）的前列腺癌诊断途径与基于随机活检的标准途径进行了比较。基于 mpMRI 的途径比标准途径表现更好。
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