背景:前瞻性随机PRECISE试验表明,在检测国际泌尿外科病理学学会(GG)≥2级前列腺癌(PC)方面,仅采用靶向活检(TBx)的磁共振成像(MRI)不劣于系统性经直肠超声活检(SBx)。一个未解决的问题是,由于MRI阴性结果而避免进行活检的患者的结果。
目的:探讨未进行活检的PRECISE参与者以及TBx阴性结果或GG1患者的2年MRI诊断PC的比率。SBx阴性结果或GG1。
方法:PRECISE前瞻性试验在加拿大的五个学术中心进行。本分析是针对基线时未被诊断为临床显着PC(csPC)的试验参与者。在453名随机患者中,146例患者在基线时诊断为GG≥2,并被排除。这项研究的合格患者包括83名MRI臂的男性,他们的MRI检查结果为阴性,没有活检。总队列中SBx或TBx为阴性的120人,和72名来自整个队列谁被诊断为GG1疾病。
方法:在2年对所有男性进行MRI和SBx臂和TBx检查,前列腺成像报告和数据系统评分≥3或基于临床怀疑的病变。
方法:主要结果是诊断为GG≥2癌的男性比例。次要结果包括MRI结果和诊断为GG1PC的男性比例。
结论:有价值的2年MRI扫描可用于MRI臂中的75例(56%)和SBx臂中的69例(49%)。在这些病人中,MRI臂中55例(73%)和51例(67%)SBx臂的2年MRI阴性。在接受2年MRI检查的SBx臂中的76例患者中,16人(21%)进行了活检,八个(10%)的结果为阴性,GG1在两个(2.6%),6例(7.9%)GG≥2。在接受2年MRI检查的75名男性中,八人(11%)进行了活检,其中4例(5%)结果为阴性,另外4例(5%)GG≥2。在2岁时,包括基线活检结果,MRI臂中的116/221(52.5%)和SBx臂中的113/204(55%)没有GG≥2疾病,治疗,死于任何原因,或进展(OR1.08;p=0.66)。
结论:经过2年的随访,包括对两组患者的MRI检查,MRI组和SBx组的CSPC诊断率无差异,尽管MRI组中38%的男性避免进行初次活检.
结果:PRECISE试验将前列腺的系统活检与磁共振成像(MRI)的策略进行了比较,并对扫描中的任何可疑癌症病灶进行了靶向活检。经过2年的随访,包括2年的MRI伴或不伴活检,显著癌症的诊断率没有差异,尽管初行MRI的男性中有38%避免进行初次活检,30%完全避免活检。PRECISE试验在ClinicalTrials.gov上注册为NCT02936258。
BACKGROUND: The prospective randomized PRECISE trial demonstrated that magnetic resonance imaging (MRI) with only targeted biopsy (TBx) was noninferior to systematic transrectal ultrasound biopsy (SBx) in the detection of International Society of Urological Pathology grade group (GG) ≥2 prostate cancer (PC). An unanswered question is the outcome for patients who avoided a biopsy because of negative MRI findings.
OBJECTIVE: To explore the rate of PC diagnosis based on 2-yr MRI for PRECISE participants who had no biopsy and for patients who had a negative result or GG 1 on TBx in comparison to those with a negative result or GG 1 on SBx.
METHODS: The PRECISE prospective trial was conducted at five Canadian academic centers. The present analysis was for trial participants who were not diagnosed with clinically significant PC (csPC) at baseline. Of 453 randomized patients, 146 were diagnosed with GG ≥2 at baseline and were excluded. Eligible patients for this study included 83 men from the MRI arm who had negative MRI findings and no biopsy, 120 from the overall cohort who had a negative SBx or TBx, and 72 from the overall cohort who were diagnosed with GG 1 disease.
METHODS: MRI at 2 yr in all men in the MRI and SBx arms and TBx for lesions with a Prostate Imaging-Reporting and Data System score of ≥3 or on the basis of clinical suspicion.
METHODS: The primary outcome was the proportion of men diagnosed with GG ≥2 cancer. Secondary outcomes included the MRI outcome and the proportion of men diagnosed with GG 1 PC.
CONCLUSIONS: Evaluable 2-yr MRI scans were available for 75 (56%) eligible patients in the MRI arm and 69 (49%) in the SBx arm. Of these patients, 55 (73%) in the MRI arm and 51 (67%) SBx arm had negative 2-yr MRI. Of the 76 patients in the SBx arm with 2-yr MRI, 16 (21%) had a biopsy, for which the result was negative in eight (10%), GG1 in two (2.6%), and GG ≥2 in six (7.9%) cases. Of the 75 men in the MRI arm with 2-yr MRI, eight (11%) were biopsied, for which the result was negative in four cases (5%) and GG ≥2 in the other four (5%). At 2 yr, including baseline biopsy results, 116/221 (52.5%) in the MRI arm and 113/204 (55%) in the SBx arm were free of GG ≥2 disease, treatment, death from any cause, or progression (OR 1.08; p = 0.66).
CONCLUSIONS: After 2-yr follow-up including MRI for patients in both arms of PRECISE, there was no difference in the rate of csPC diagnosis between the MRI and SBx groups, even though 38% of men in the MRI group avoided an initial biopsy.
RESULTS: The PRECISE trial compared systematic biopsy of the prostate to a strategy of magnetic resonance imaging (MRI) with targeted biopsy of any lesions suspicious for cancer on the scan. After 2 years of follow-up that included 2-year MRI with or without biopsy in both groups, there was no difference in the rate of diagnosis of significant cancer, even though 38% of men in the initial MRI arm avoided an initial biopsy, and 30% avoided biopsy altogether. The PRECISE trial is registered on ClinicalTrials.gov as NCT02936258.