Barletta Francesco, Stabile Armando, Mazzone Elio, Brembilla Giorgio, Sorce Gabriele, Pellegrino Francesco, Scuderi Simone, Cannoletta Donato, Cirulli Giuseppe Ottone, Cucchiara Vito, Gandaglia Giorgio, De Cobelli Francesco, Montorsi Francesco, Briganti Alberto
Department of Urology and Division of Experimental Oncology, URI, Urological Research Institute, Vita-Salute San Raffaele University, IRCCS San Raffaele Scientific Institute, Milan, Italy.
Department of Urology and Division of Experimental Oncology, URI, Urological Research Institute, Vita-Salute San Raffaele University, IRCCS San Raffaele Scientific Institute, Milan, Italy.
Urol Oncol. 2022 Mar;40(3):103.e17-103.e24. doi: 10.1016/j.urolonc.2021.09.015. Epub 2021 Oct 27.
We aimed at optimizing the follow-up for patients with a positive multiparametric magnetic resonance of the prostate (mpMRI) and a subsequent negative targeted biopsy (TBx) plus systematic biopsy (SBx).
A total of 308 men with a clinical suspicion of PCa and a positive mpMRI (PI-RADS ≥ 3) with concomitant negative systematic and targeted Bx performed at a single tertiary referral center. All patients were then followed with serial PSA measurements, digital rectal examination and eventual follow-up mpMRI and/or repeat Bx. The primary outcome was to evaluate the overall clinically significant PCa (csPCa)-free survival. The secondary outcome was to assess the role of a repeat mpMRI (Fu-mpMRI) and PSA density as predictors of csPCa diagnosis (defined as Gleason score ≥ 3 + 4) during follow-up. Kaplan Meier analysis and univariable Cox regression were used for survival and predictive analyses.
Median follow-up was 31 months (IQR: 23-43). During the study period 116 (37.7%) and 68 (22.1%) of men received a Fu-mpMRI and a Fu-Bx, respectively. Overall, 51 (16.6%) and 15 (4.9%) patients had a positive mpMRI and clinically significant (csPCa) diagnosis during follow-up, respectively. Among 68 men who received a Fu-Bx, the 2- and 3-years csPCa diagnosis-free survival in men with negative vs. positive Fu-mpMRI was 97% vs. 65% and 92% vs. 65%, respectively. At univariate Cox-regression analysis the presence of a positive Fu-mpMRI resulted to be significantly associated with the presence of csPCa at Fu-Bx (HR: 5.8, 95% CI: 1.3-26.6, P = 0.008). The 2- and 3-years csPCa diagnosis-free survival in men with PSAd <0.15 vs. ≥0.15 was 89% vs. 77%, and 86% vs. 66%, respectively (HR: 2.6, 95% CI: 0.75-8.87, P = 0.13). The combination of negative Fu-mpMRI and PSAd<0.15 furtherly reduced the probability of csPCa diagnosis at Fu-Bx at only 6% at 3years (HR: 9.9, 95% CI: 1.9-38.6, P < 0.001) in this subgroup of patients.
After a negative TBx for a positive mpMRI, more than half of Fu-mpMRI were negative. A persistent positive mpMRI was associated with a significant risk of csPCa. The risk of csPCa diagnosis in men with negative mpMRI performed after negative TBx and low PSAd was negligible.
我们旨在优化对前列腺多参数磁共振成像（mpMRI）呈阳性且随后靶向活检（TBx）及系统活检（SBx）均为阴性的患者的随访。
在一家单一的三级转诊中心，共有308名临床怀疑患有前列腺癌（PCa）且mpMRI呈阳性（前列腺影像报告和数据系统[PI-RADS]≥3）同时系统活检和靶向活检均为阴性的男性患者。随后对所有患者进行连续的前列腺特异性抗原（PSA）测量、直肠指检，并最终进行随访mpMRI和/或重复活检。主要结局是评估总体无临床显著前列腺癌（csPCa）生存率。次要结局是评估重复mpMRI（随访mpMRI[Fu-mpMRI]）和PSA密度作为随访期间csPCa诊断（定义为Gleason评分≥3+4）预测指标的作用。采用Kaplan-Meier分析和单变量Cox回归进行生存分析和预测分析。
中位随访时间为31个月（四分位间距：23-43个月）。在研究期间，分别有116名（37.7%）和68名（22.1%）男性接受了随访mpMRI和随访活检（Fu-Bx）。总体而言，分别有51名（16.6%）和15名（4.9%）患者在随访期间mpMRI呈阳性且被诊断为临床显著前列腺癌（csPCa）。在接受Fu-Bx的68名男性中，Fu-mpMRI为阴性与阳性的男性患者2年和3年无csPCa诊断生存率分别为97%对65%和92%对65%。在单变量Cox回归分析中，Fu-mpMRI呈阳性与Fu-Bx时存在csPCa显著相关（风险比[HR]：5.8，95%置信区间[CI]：1.3-26.6，P=0.008）。PSA密度（PSAd）<0.15与≥0.15的男性患者2年和3年无csPCa诊断生存率分别为89%对77%和86%对66%（HR：2.6，95%CI：0.75-8.87，P=0.13）。在该亚组患者中，Fu-mpMRI阴性且PSAd<0.15的组合进一步将Fu-Bx时csPCa诊断的概率在3年时仅降低至6%（HR：9.9，95%CI：1.9-38.6，P<0.001）。
对于mpMRI呈阳性但TBx为阴性的患者，超过一半的随访mpMRI为阴性。持续的mpMRI阳性与csPCa的显著风险相关。TBx为阴性且PSAd较低时进行的mpMRI为阴性的男性患者中，csPCa诊断风险可忽略不计。
