Kumar Rajender, Singh Shrawan Kumar, Mittal Bhagwant Rai, Vadi Shelvin Kumar, Kakkar Nandita, Singh Harmandeep, Krishnaraju Venkata Subramanian, Kumar Santosh, Bhattacharya Anish
From the Departments of Nuclear Medicine (R.K., B.R.M., S.K.V., H.S., V.S.K., A.B.), Urology (S.K.S., S.K.), and Pathology (N.K.), Post Graduate Institute of Medical Education and Research, Chandigarh 160012, India.
Radiology. 2022 May;303(2):392-398. doi: 10.1148/radiol.204066. Epub 2022 Feb 22.
Background Transrectal US-guided biopsy with or without MRI fusion is performed for diagnosing prostate cancer (PCa) but has limitations. Gallium 68 (Ga) prostate-specific membrane antigen (PSMA) PET/CT-guided targeted biopsy has the potential to improve diagnostic yield of PCa. Purpose To evaluate the safety and diagnostic yield of Ga PSMA PET/CT-guided, robotic-arm assisted transgluteal prostatic biopsy. Materials and Methods In this single-center nonrandomized prospective trial, participants with a clinical suspicion of PCa (serum prostate-specific antigen level > 4 ng/mL) were recruited from January 2019 to September 2020. After whole-body Ga PSMA PET/CT, participants with PSMA-avid intraprostatic lesions underwent PET-guided transgluteal biopsy by using an automated robotic arm. To assess safety and diagnostic yield, procedure-related complications and histopathologic results were documented. Pain during the procedure was scored by a visual analog scale. Descriptive statistics were applied; qualitative variables were reported in percentages. Results Seventy-eight participants (mean age, 66 years ± 7 [standard deviation]; 36 participants [46%] with prior negative results at transrectal US-guided biopsy) were enrolled. Fifty-six (72%) participants had PSMA-avid lesions (prior negative results at transrectal US-guided biopsy in 22 of 56 [39%]) and underwent targeted biopsy. PCa was confirmed in 54 of 56 (96%) participants, and clinically significant PCa (Gleason score ≥ 7) was confirmed in 24 of 54 (44%). Two participants had nonrepresentative samples that required rebiopsy. All participants experienced pain during the procedure, mild (median visual analog scale score, 1; interquartile range, 1-2) in 36 of 56 (64%) and moderate (median visual analog scale score, 5; interquartile range, 5-6) in 20 of 56 (36%). Postprocedure complications were noted in five of 56 (9%) participants and were minor (hematuria, four participants; hematospermia, one participant; and gluteal pain, two participants). No participant developed a postprocedural infection. Conclusion Transgluteal prostate-specific membrane antigen (PSMA) PET/CT-guided, robotic-targeted prostatic biopsy is safe with a high diagnostic yield of prostate cancer for PSMA-avid lesions. Clinical trial registration no. NCT05022576 © RSNA, 2022.
经直肠超声引导下活检（无论有无MRI融合）用于诊断前列腺癌（PCa），但存在局限性。镓68（Ga）前列腺特异性膜抗原（PSMA）PET/CT引导下的靶向活检有可能提高PCa的诊断率。目的：评估Ga PSMA PET/CT引导下机器人手臂辅助经臀前列腺活检的安全性和诊断率。材料与方法：在这项单中心非随机前瞻性试验中，2019年1月至2020年9月招募了临床怀疑患有PCa（血清前列腺特异性抗原水平>4 ng/mL）的参与者。在进行全身Ga PSMA PET/CT检查后，对有PSMA摄取的前列腺内病变的参与者使用自动机器人手臂进行PET引导下的经臀活检。为评估安全性和诊断率，记录了与手术相关的并发症和组织病理学结果。手术过程中的疼痛采用视觉模拟评分法进行评分。应用描述性统计；定性变量以百分比报告。结果：共纳入78名参与者（平均年龄66岁±7[标准差]；36名参与者[46%]此前经直肠超声引导下活检结果为阴性）。5 six名（72%）参与者有PSMA摄取的病变（56名中有22名[39%]此前经直肠超声引导下活检结果为阴性）并接受了靶向活检。56名参与者中有54名（96%）确诊为PCa，54名中有24名（44%）确诊为具有临床意义的PCa（Gleason评分≥7）。两名参与者的样本不具代表性，需要再次活检。所有参与者在手术过程中均经历疼痛，56名中有36名（64%）为轻度疼痛（视觉模拟评分中位数为1；四分位间距为1 - 2），56名中有20名（36%）为中度疼痛（视觉模拟评分中位数为5；四分位间距为5 - 6）。56名参与者中有5名（9%）出现术后并发症，均为轻微并发症（4名参与者出现血尿；1名参与者出现血精；2名参与者出现臀痛）。没有参与者发生术后感染。结论：经臀前列腺特异性膜抗原（PSMA）PET/CT引导下的机器人靶向前列腺活检对于有PSMA摄取的病变是安全的，对前列腺癌具有较高的诊断率。临床试验注册号：NCT05022576 © RSNA，2022。
