Maiolino Giuseppe, Lopez-Prieto Alberto, Egui-Benatuil Gloria, Kaufman Ariel M, Gheiler Edward L, Bianco Fernando J
Urological Research Network, Miami Lakes, Florida, USA.
J Endourol. 2025 Mar;39(S2):S13-S20. doi: 10.1089/end.2024.0776. Epub 2025 Jan 24.
Focal therapy (FT) is an emerging option for intermediate-risk prostate cancer (IR-PCa). Transperineal MRI fusion laser ablation of PCa (TPFLA) is a novel FT technique with limited data reported. We conducted a phase I clinical trial evaluating the safety, feasibility, and 1-year oncologic results for patients with IR-PCa treated with TPFLA in an office setting. NCT05241236 aimed to evaluate TPFLA for the International Society of Urological Pathology-grade 2 (ISUP-2) tumors. All procedures were performed in the office using MR/US fusion imaging. The diode interstitial laser system fibers were applied through the perineum using local anesthesia. The primary outcome was safety and tolerability. Pain scores were recorded using analog scales. Thirty-day adverse events and 1-year prostate biopsy oncologic outcomes were noted. Functional outcomes at 3 months and 1 year were compared with baseline as well. Thirty patients accrued had TPFLA safely in the office with no complications. TPFLA median pain score was 1. At 30 days, one man required a transurethral resection of the prostate (TURP). There were no imaging demonstrable cancers at 3 months and a significant improvement in urinary function ( = 0.001) was noted and sustained for the year. No patient experienced urinary incontinence. No changes in sexual function were observed ( = 0.7). At 1 year, 25/30 (83%) had no clinically significant cancer. However, 14 had PCa, in 5 (17%) solely in treated areas, all ISUP-1. Seven had PCa outside the treated areas. Two had infield and outfield recurrences, both were ISUP 2. At study closure, 16 patients were free from PCa, 3 were on active surveillance, 9 were treated focally with cryoablation, and 2 were converted to radical surgical procedure. TPFLA appears to be a safe and an effective focal therapy for IR-PCa, offering a potential alternative to more radical treatments with a minimal periprocedural impact. Longer follow-up and larger studies are needed to confirm these results.
聚焦治疗（FT）是中危前列腺癌（IR-PCa）的一种新兴治疗选择。经会阴磁共振成像融合激光消融前列腺癌（TPFLA）是一种新型的聚焦治疗技术，目前报道的数据有限。我们开展了一项I期临床试验，评估在门诊环境中接受TPFLA治疗的IR-PCa患者的安全性、可行性和1年肿瘤学结果。NCT05241236旨在评估TPFLA用于国际泌尿病理学会2级（ISUP-2）肿瘤的情况。所有手术均在门诊使用磁共振/超声融合成像进行。二极管间质激光系统光纤在局部麻醉下经会阴置入。主要结局是安全性和耐受性。使用视觉模拟评分记录疼痛评分。记录30天不良事件和1年前列腺穿刺活检的肿瘤学结果。还比较了3个月和1年时的功能结局与基线情况。30例入组患者在门诊安全接受了TPFLA治疗，无并发症。TPFLA的疼痛评分中位数为1分。30天时，1名男性需要行经尿道前列腺切除术（TURP）。3个月时未发现影像学可证实的癌症，且尿功能有显著改善（P = 0.001），并持续了一年。无患者发生尿失禁。未观察到性功能改变（P = 0.7）。1年时，25/30（83%）患者无临床显著癌症。然而，14例患者患有前列腺癌，5例（17%）仅在治疗区域，均为ISUP-1级。7例患者在治疗区域外患有前列腺癌。2例患者在治疗区域内和区域外均复发，均为ISUP 2级。在研究结束时，16例患者无前列腺癌，3例接受主动监测，9例接受冷冻消融局部治疗，2例转为根治性手术。TPFLA似乎是一种安全有效的IR-PCa聚焦治疗方法，为更激进的治疗提供了一种潜在替代方案，围手术期影响最小。需要更长时间的随访和更大规模的研究来证实这些结果。
