mpMRI联合^(68)Ga-PSMA PET/CT诊断高度可疑前列腺癌免穿刺行根治性切除术的可行性

Feasibility of radical prostatectomy without biopsy for patients with highly suspected localized prostate cancer diagnosed by mpMRI and^(68)Ga-PSMA PET/CT

目的探讨多参数磁共振(mpMRI)联合^(68)Ga前列腺特异性膜抗原(PSMA)PET/CT诊断的高度可疑前列腺癌患者免穿刺行根治性切除术的可行性。方法本研究为单臂临床前瞻性研究。2019年3月至2022年1月,天津医科大学第二医院收治的符合入组条件的患者纳入研究。纳入标准:①身体一般状况良好,年龄≤80岁,美国东部肿瘤协作组(ECOG)评分0~1分;②mpMRI和^(68)Ga-PSMA PET/CT结果提示高度可疑局限性前列腺癌,无远处淋巴结、骨骼、内脏转移。排除标准:①明显心肺功能异常或其他重要脏器功能障碍;②检查结果提示可疑远处转移病灶;③有其他恶性肿瘤病史。患者及家属充分理解手术风险和术后病理可能后,行免穿刺腹腔镜或机器人辅助腹腔镜根治性前列腺切除术。以最终病理结果为参照,评估mpMRI联合^(68)Ga-PSMA PET/CT诊断前列腺癌的准确性。按^(68)Ga-PSMA PET/CT最大标准摄取值(SUV_(max))将患者分为低SUV_(max)组(SUV_(max)<10)和高SUV_(max)组(SUV_(max)≥10),比较两组的切缘、精囊侵犯、pT分期和国际泌尿病理学会(ISUP)分级分组情况。比较有临床意义前列腺癌(CsPCa)组和非CsPCa组[无临床意义前列腺癌(cisPCa)+高级别前列腺上皮内瘤变(HGPIN)]的基线特征。分析CsPCa组中,不同pT分期、ISUP分级分组和危险度亚组中基线前列腺特异性抗原(PSA)水平、前列腺体积、SUV_(max)、前列腺影像报告和数据系统(PI-RADS)评分的差异。结果本研究共纳入31例患者。中位年龄^(68)(48~79)岁。中位体质指数25.6(21.9~31.4)kg/m^(2)。中位PSA 23.5(5.6~94.7)ng/ml,中位前列腺体积37.6(16.2~127.9)ml,中位PSA密度(PSAD)0.56(0.11~2.86)ng/ml^(2)。mpMRI的PI-RADS评分4分15例,5分16例。^(68)Ga-PSMA PET/CT的中位SUV_(max)13.3(4.6~36.7)。所有患者手术均顺利完成,无中转开放。术后中位住院时间5(4~7)d。围手术期均未出现严重并发症,6个月内均恢复尿控。术后病理结果提示HGPIN 1例(3.2%);前列腺腺癌30例(96.8%),其中CsPCa 26例(86.7%),cisPCa 4例(13.3%)。30例前列腺癌患者中,T_(2)期11例(36.7%),T_(3)期19例(63.3%);ISUP分级分组1组4例(13.3%),2组7例(23.3%),3组7例(23.3%),≥4组12例(40.0%);低危2例(6.7%),中危3例(10.0%),高危25例(83.3%);切缘阳性12例(40.0%)。18例(前列腺癌17例,HGPIN 1例)同时行标准淋巴结清扫术,共清扫淋巴结62枚,均为阴性。mpMRI联合^(68)Ga-PSMA PET/CT诊断前列腺癌的准确率为96.8%(30/31)。30例前列腺癌患者中,高SUV_(max)组22例,低SUV_(max)组8例。高SUV_(max)组中ISUP分级分组1、2、3、≥4组者分别为0、6、5、11例,低SUV_(max)组中分别为4、1、2、1例,差异有统计学意义(P=0.003)。高SUV_(max)组和低SUV_(max)组切缘阳性分别为12例和1例(P=0.092);精囊侵犯分别为4例和2例(P=0.680);pT2、pT3期分别为6例和5例、16例和3例(P=0.077),差异均无统计学意义。CsPCa组26例中,PI-RADS评分4分10例(38.5%),5分16例(61.5%);中位SUV_(max)14.3(6.1~36.7)。CsPCa组和非CsPCa组的前列腺体积中位值分别为34.3 ml和73.0 ml(P=0.006),PSAD中位值分别为0.70 ng/ml^(2)和0.13 ng/ml^(2)(P=0.001),PI-RADS评分5分者分别为16例和0例(P=0.018),SUV_(max)中位值分别为14.3和6.1(P=0.001),差异均有统计学意义。亚组分析结果显示,CsPCa组SUV_(max)在不同pT分期(T_(2)期与T_(3)期:25.5与13.9)、ISUP分级分组(2、3、4组:15.4与14.4与14.0)和危险分层中(中危与高危:9.7与14.9)差异均无统计学意义(P>0.05)。结论mpMRI联合^(68)Ga-PSMA PET/CT诊断前列腺癌的准确性较高。对于综合诊断结果提示高度可疑局限性前列腺癌患者,免穿刺行根治性前列腺切除术较安全,在充分沟通的前提下可尝试开展。

Objective To explore the feasibility of radical prostatectomy without biopsy for patients with highly suspected localized prostate cancer diagnosed by multiparametric magnetic resonance imaging(mpMRI)and^(68)Ga-PSMA PET/CT.Methods Patients were enrolled in this single-arm prospective study from March 2019 to January 2022 in the Second Hospital of Tianjin Medical University.Eligible patients were aged≤80 years with an Eastern Cooperative Oncology Group(ECOG)performance-status score of 0 or 1.Based on mpMRI and^(68)Ga-PSMA PET/CT,patients were diagnosed with highly suspected localized prostate cancer with no evidence of distant lymphatic,bone or visceral metastases.Patients were excluded if they had obvious important organs dysfunction,suspected metastatic lesions or history of other malignant tumor.After fully informed of the surgical risks and possibilities of final pathology,patients received laparoscopic or robot-assisted laparoscopic radical prostatectomy.According to final pathological results,the diagnostic accuracy of mpMRI and^(68)Ga-PSMA PET/CT was evaluated.Pathological features were compared between low^(68)Ga-PSMA PET/CT_(max)imum standardized uptake value(SUV_(max))group(SUV_(max)<10)and high SUV_(max)group(SUV_(max)≥10).Baseline characteristics were compared between clinically significant prostate cancer(CsPCa)and clinically insignificant prostate cancer(cisPCa)+high grade prostatic intraepithelial neoplasia(HGPIN)patients.Additional analysis of the correlation between baseline parameters and different subgroups including pathological stage,ISUP grades and risk groups were performed in CsPCa patients.Results 31 patients were enrolled.Median age was^(68)(ranging 48-79)years old.Median BMI was 25.6(ranging 21.9-31.4)kg/m^(2).Median prostate specific antigen(PSA)was 23.5(ranging 5.6-94.7)ng/ml.Median prostate volume was 37.6(ranging 16.2-127.9)ml.Median PSA density(PSAD)was 0.56(ranging 0.11-2.86)ng/ml^(2).Fifteen cases were scored prostate imaging reporting and data system(PI-RADS)4 and 16 cases were scored PI-RADS 5.Median^(68)Ga-PSMA PET/CT SUV_(max)was 13.3(ranging 4.6-36.7).All surgeries were successfully accomplished without open conversion.Median postoperative hospitalization time was 5(ranging 4-7)d.No major complication occurred perioperatively.Recovery of urinary continence was within 6 months in all patients.According to the final pathological results,1(3.2%)patient was confirmed with HGPIN.30(96.8%)patients were confirmed with adenocarcinoma,including 26(86.7%)patients with CsPCa and 4(13.3%)patients with cisPCa.Among prostate cancer cases,the pathological stage of 11(36.7%)was T_(2) and 19(63.3%)was T_(3).Four(13.3%)cases were with ISUP grade 1,7(23.3%)cases were with ISUP grade 2,7(23.3%)cases were with ISUP grade 3 and 12(40.0%)cases were with ISUP grade≥4.Two(6.7%)cases were in low risk group,3(10.0%)cases were in intermediate risk group and 25(83.3%)cases were in high risk group.Twelve(40.0%)patients had positive surgical margins.Standard pelvic lymph node dissection was carried out in 18(17 prostate cancer and 1 HGPIN)cases.Sixty-two lymph nodes were dissected and none of them was positive.The diagnostic accuracy of mpMRI and^(68)Ga-PSMA PET/CT was 96.8%(30/31)in prostate cancer.Compared to low SUV_(max)group,patients in high SUV_(max)group had higher ISUP grade(P=0.003)but there was no significant difference in positive surgical margin,se_(min)al vesical invasion or pathological stage(P>0.05).Among CsPCa patients,10(38.5%)cases were scored PI-RADS 4 and 16(61.5%)cases were scored PI-RADS 5.Median^(68)Ga-PSMA PET/CT SUV_(max)was 14.3(range 6.1-36.7).Compared to cisPCa and HGPIN patients,a smaller median prostate volume(34.3 vs.73.0 ml,P=0.006),higher median PSAD(0.70 vs.0.13 ng/ml^(2),P=0.001),higher rates of PI-RADS 5 patients(61.5%vs.0,P=0.018)and higher^(68)Ga-PSMA PET/CT SUV_(max)(14.3 vs.6.1,P=0.001)were found in CsPCa patients.Subgroup analysis showed no significant difference between SUV_(max)and pathological stage(25.5 vs.13.9),ISUP grades(15.4 vs.14.4 vs.14.0)and risk groups(9.7 vs.14.9)in CsPCa patients(P>0.05).Conclusions The diagnostic accuracy of mpMRI and^(68)Ga-PSMA PET/CT is high in prostate cancer.With efficient communication,radical prostatectomy without biopsy for patients with highly suspected localized prostate cancer diagnosed by mpMRI and^(68)Ga-PSMA PET/CT is safe.