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磁共振引导聚焦高频超声消融治疗前列腺癌 - 1 期试验。

Magnetic resonance guided focused high frequency ultrasound ablation for focal therapy in prostate cancer - phase 1 trial.

机构信息

Toronto Joint Department of Medical Imaging, University Health Network - Mt Sinai Hospital - Women's College Hospital, University of Toronto, Toronto, ON, Canada.

1PMB-283, Toronto General Hospital, 585 University Avenue, Toronto, ON, M5G 2N2, Canada.

出版信息

Eur Radiol. 2018 Oct;28(10):4281-4287. doi: 10.1007/s00330-018-5409-z. Epub 2018 Apr 25.

DOI:10.1007/s00330-018-5409-z
PMID:29696431
Abstract

OBJECTIVES

To evaluate the feasibility and safety of focal therapy for low-intermediate risk prostate cancer (PCa) with magnetic resonance-guided high frequency focused ultrasound (MRgFUS) METHODS: This IRB-approved phase 1 prospective study enrolled eight patients with prostate specific antigen (PSA) ≤ 10 ng/ml, ≤ cT2a and Gleason score ≤ 7 (4 + 3) disease following informed consent. Under MRI guidance, focused high frequency ultrasound energy was delivered to ablate the target tissue. Treatment-related adverse events were recorded. Oncologic outcomes were evaluated with multiparametric MRI, PSA and TRUS biopsy at 6 months following treatment.

RESULTS

Ten target lesions [six Gleason 6 lesions, two Gleason 7 (3 + 4) and two Gleason 7 (4 + 3)] were treated in eight men (prostate volume range, 25-50 cc; mean MRI time, 248 min per patient; mean sonication duration, 65 min). Mean target volume was 2.7 cc and mean post-treatment non-perfused volume was 4.3 cc. Quality of life parameters were similar between baseline and 6 months in 6/8 patients. All treated regions were negative on MRI; 4/8 patients and 6/10 target lesions (60%) were clear of disease on biopsy. One patient with 2-mm Gleason 8 disease in one of five cores from treatment site (4 + 3 disease at baseline) subsequently underwent prostatectomy with negative surgical margins. Three patients with low volume (5-15%) Gleason 6 residual disease were offered active surveillance. Mean PSA decreased from 5.06 at baseline to 3.4 ng/ml at 6 months.

CONCLUSION

MRgFUS is a feasible and safe method of noninvasively ablating low-intermediate risk PCa with acceptable short-term oncologic outcomes.

KEY POINTS

• Focal therapy selectively ablates locally confined, clinically significant index lesion with a margin while sparing rest of gland and adjacent vital structures. • Magnetic resonance-guided focused high frequency ultrasound surgery (MRgFUS) combines MRI with HIFU. • MRgFUS provides ability to monitor treatments in real time and allows a targeted approach for focal ablation. • MRgFUS is a feasible, safe method of noninvasively ablating low-intermediate risk PCa. • MRgFUS provides acceptable oncologic outcomes at 6 months.

摘要

目的

评估磁共振引导下高频聚焦超声(MRgFUS)治疗低中危前列腺癌(PCa)的可行性和安全性。

方法

这项经机构审查委员会批准的 1 期前瞻性研究纳入了 8 名前列腺特异抗原(PSA)≤10ng/ml、cT2a 以下和 Gleason 评分≤7(4+3)的患者,所有患者均在知情同意后入组。在 MRI 引导下,将聚焦高频超声能量传递到靶组织以进行消融。记录与治疗相关的不良事件。治疗后 6 个月,通过多参数 MRI、PSA 和经直肠超声活检评估肿瘤学结果。

结果

8 名男性患者的 10 个靶病灶[6 个 Gleason 6 病变、2 个 Gleason 7(3+4)病变和 2 个 Gleason 7(4+3)病变]接受了治疗(前列腺体积范围为 25-50cc;每位患者的 MRI 时间平均为 248 分钟,超声时间平均为 65 分钟)。平均靶体积为 2.7cc,平均治疗后非灌注体积为 4.3cc。6/8 名患者的生活质量参数在基线和 6 个月时相似。所有治疗区域的 MRI 结果均为阴性;4/8 名患者和 6/10 个靶病灶(60%)的活检结果为无疾病。一名患者的治疗部位有 1 个 2mm 的 Gleason 8 病变(基线时为 4+3 病变),随后行前列腺切除术且切缘阴性。3 名患者的 Gleason 6 残留病变体积较小(5-15%),建议接受主动监测。PSA 从基线时的 5.06ng/ml 降至 6 个月时的 3.4ng/ml。

结论

MRgFUS 是一种可行且安全的非侵入性治疗低中危 PCa 的方法,具有可接受的短期肿瘤学结果。

关键点

  • 局灶性治疗选择性地消融局部局限性、有临床意义的病灶,同时保留腺体的其余部分和相邻的重要结构。

  • 磁共振引导下高频聚焦超声手术(MRgFUS)将 MRI 与 HIFU 相结合。

  • MRgFUS 能够实时监测治疗并为局灶性消融提供靶向治疗。

  • MRgFUS 是一种可行、安全的非侵入性治疗低中危 PCa 的方法。

  • MRgFUS 在 6 个月时提供可接受的肿瘤学结果。

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