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磁共振引导前列腺癌聚焦激光消融术的 II 期评估。

Phase II Evaluation of Magnetic Resonance Imaging Guided Focal Laser Ablation of Prostate Cancer.

机构信息

Section of Urology, University of Chicago Medicine, Chicago, Illinois.

Department of Radiology, University of Chicago Medicine, Chicago, Illinois.

出版信息

J Urol. 2016 Dec;196(6):1670-1675. doi: 10.1016/j.juro.2016.07.074. Epub 2016 Jul 20.

DOI:10.1016/j.juro.2016.07.074
PMID:27449263
Abstract

PURPOSE

Magnetic resonance imaging guided focal laser ablation is an investigational strategy for the treatment of prostate cancer.

MATERIALS AND METHODS

This phase II evaluation of focal laser ablation included men with stage T1c-T2a, prostate specific antigen less than 15 ng/ml or prostate specific antigen density less than 0.15 ng/ml, Gleason 7 or less in 25% or less of biopsies and magnetic resonance imaging with 1 or 2 lesions concordant with biopsy detected cancer. At 3 months all patients underwent magnetic resonance imaging with biopsy of ablation zone(s). At 12 months all underwent magnetic resonance imaging and systematic biopsy. I-PSS (International Prostate Symptom Score) and SHIM (Sexual Health Inventory for Men) scores were collected before focal laser ablation, and at 1, 3 and 12 months. The primary end point was no cancer on the 3-month ablation zone biopsy. Secondary end points were safety, 12-month biopsy, and urinary and sexual function.

RESULTS

In the 27 men median age was 62 years and mean prostate specific antigen was 4.4 ng/ml. Biopsy Gleason score was 6 in 23 patients (85%) and Gleason 7 in 4 (15%). Seven men (26%) had low volume Gleason 6 disease outside the intended ablation zone(s). At 3 months 26 patients (96%) had no evidence of cancer on magnetic resonance imaging guided biopsy of the ablation zone. No significant I-PSS changes were observed (each p >0.05). SHIM was lower at 1 month (p = 0.03), marginally lower at 3 months (p = 0.05) and without a significant difference at 12 months (p = 0.38). At 12-month biopsy cancer was identified in 10 patients (37%), including in the ablation zone(s) in 3 (11%) and outside the ablation zone(s) in 8 (30%) with cancer in and outside the ablation zone in 1.

CONCLUSIONS

In select men with localized prostate cancer and visible magnetic resonance imaging lesions focal laser ablation has an acceptable morbidity profile and is associated with encouraging short-term oncologic outcomes. Significantly longer followup is mandatory to fully assess this novel treatment.

摘要

目的

磁共振引导下的聚焦激光消融术是治疗前列腺癌的一种研究策略。

材料与方法

本研究为 II 期聚焦激光消融评估,纳入了 T1c-T2a 期、前列腺特异性抗原(PSA)<15ng/ml 或 PSA 密度<0.15ng/ml、25%或更少的活检中 Gleason 评分<7 或 7 分且有 1 或 2 个磁共振成像(MRI)与活检检出的癌症一致的局限性前列腺癌患者。术后 3 个月所有患者行 MRI 引导下的消融区活检。术后 12 个月所有患者行 MRI 和系统活检。聚焦激光消融术前、术后 1、3 和 12 个月采集国际前列腺症状评分(I-PSS)和男性性功能健康问卷(SHIM)评分。主要终点为 3 个月时消融区活检未见癌症。次要终点为安全性、12 个月活检、尿控和性功能。

结果

27 例患者中位年龄为 62 岁,平均 PSA 为 4.4ng/ml。23 例(85%)患者活检 Gleason 评分为 6 分,4 例(15%)患者为 Gleason 7 分。7 例(26%)患者在拟消融区外有低体积的 Gleason 6 病变。术后 3 个月,26 例(96%)患者 MRI 引导的消融区活检未见癌。I-PSS 无明显变化(p >0.05)。SHIM 在术后 1 个月(p = 0.03)、术后 3 个月(p = 0.05)时略低,但在术后 12 个月时无显著差异(p = 0.38)。术后 12 个月活检时,10 例(37%)患者发现癌症,其中 3 例(11%)在消融区,8 例(30%)在消融区外,1 例在消融区内外均有癌症。

结论

在选择的局限性前列腺癌患者中,可见 MRI 病变的患者行聚焦激光消融术具有可接受的发病率,且与令人鼓舞的短期肿瘤学结果相关。需要更长时间的随访才能全面评估这种新的治疗方法。

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