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机器人辅助前列腺特异性膜抗原放射性核素引导挽救性手术治疗复发性前列腺癌的 DROP-IN 伽马探针的首次前瞻性可行性研究。

Robot-assisted Prostate-specific Membrane Antigen-radioguided Salvage Surgery in Recurrent Prostate Cancer Using a DROP-IN Gamma Probe: The First Prospective Feasibility Study.

机构信息

Department of Urology, Netherlands Cancer Institute-Antoni van Leeuwenhoek Hospital, Amsterdam, The Netherlands; Netherlands Prostate Cancer Network, Amsterdam, The Netherlands.

Department of Urology, Netherlands Cancer Institute-Antoni van Leeuwenhoek Hospital, Amsterdam, The Netherlands; Interventional Molecular Imaging Laboratory, Department of Radiology, Leiden University Medical Center, Leiden, The Netherlands.

出版信息

Eur Urol. 2022 Jul;82(1):97-105. doi: 10.1016/j.eururo.2022.03.002. Epub 2022 Mar 24.

DOI:10.1016/j.eururo.2022.03.002
PMID:35339318
Abstract

BACKGROUND

It has been proven that intraoperative prostate-specific membrane antigen (PSMA)-targeted radioguidance is valuable for the detection of prostate cancer (PCa) lesions during open surgery. Rapid extension of robot-assisted, minimally invasive surgery has increased the need to make PSMA-radioguided surgery (RGS) robot-compliant.

OBJECTIVE

To evaluate whether the miniaturized DROP-IN gamma probe facilitates translation of PSMA-RGS to robotic surgery in men with recurrent PCa.

DESIGN, SETTING, AND PARTICIPANTS: This prospective feasibility study included 20 patients with up to three pelvic PCa recurrences (nodal or local) on staging PSMA positron emission tomography (PET) after previous curative-intent therapy.

SURGICAL PROCEDURE

Robot-assisted PSMA-RGS using the DROP-IN gamma probe was carried out 19-23 h after intravenous injection of technetium PSMA-Investigation & Surgery (Tc-PSMA-I&S).

MEASUREMENTS

The primary endpoint was the feasibility of robot-assisted PSMA-RGS. Secondary endpoints were a comparison of the radioactive status (positive or negative) of resected specimens and final histopathology results, prostate-specific antigen (PSA) response following PSMA-RGS, and complications according to the Clavien-Dindo classification.

RESULTS AND LIMITATIONS

Using the DROP-IN probe, 19/21 (90%) PSMA-avid lesions could be resected robotically. On a per-lesion basis, the sensitivity and specificity of robot-assisted PSMA-RGS was 86% and 100%, respectively. A prostate-specific antigen (PSA) reduction of >50% and a complete biochemical response (PSA <0.2 ng/ml) were seen in 12/18 (67%) and 4/18 (22%) patients, respectively. During follow-up of up to 15 mo, 4/18 patients (22%) remained free of biochemical recurrence (PSA ≤0.2 ng/ml). One patient suffered from a Clavien-Dindo grade >III complication.

CONCLUSIONS

The DROP-IN probe helps in realizing robot-assisted PSMA-RGS. The procedure is technically feasible for intraoperative detection of nodal or local PSMA-avid PCa recurrences.

PATIENT SUMMARY

A device called the DROP-IN probe facilitates minimally invasive, robot-assisted surgery guided by radioactive tracers in patients with recurrent prostate cancer. This procedure holds promise for improving the intraoperative identification and removal of prostate cancer lesions.

摘要

背景

研究已经证实,术中前列腺特异性膜抗原(PSMA)靶向放射导航对于开放手术中前列腺癌(PCa)病灶的检测具有重要价值。机器人辅助微创手术的快速发展增加了使 PSMA 放射性引导手术(RGS)机器人兼容的需求。

目的

评估微型化 DROP-IN 伽马探头是否有助于将 PSMA-RGS 转化为复发性 PCa 男性的机器人手术。

设计、设置和参与者:这项前瞻性可行性研究纳入了 20 名接受过根治性治疗后,在分期 PSMA 正电子发射断层扫描(PET)上有多达三次骨盆 PCa 复发(淋巴结或局部)的患者。

手术过程

在静脉注射锝 PSMA-研究与手术(Tc-PSMA-I&S)后 19-23 小时,使用 DROP-IN 伽马探头进行机器人辅助 PSMA-RGS。

测量

主要终点是机器人辅助 PSMA-RGS 的可行性。次要终点是比较切除标本的放射性状态(阳性或阴性)和最终组织病理学结果、PSMA-RGS 后前列腺特异性抗原(PSA)的反应以及根据 Clavien-Dindo 分类的并发症。

结果和局限性

使用 DROP-IN 探头,可切除 19/21(90%)个 PSMA 阳性病灶。基于每一个病灶,机器人辅助 PSMA-RGS 的敏感性和特异性分别为 86%和 100%。18 例患者中有 12 例(67%)PSA 降低>50%,4 例(22%)完全生化缓解(PSA <0.2ng/ml)。在长达 15 个月的随访中,18 例患者中有 4 例(22%)无生化复发(PSA ≤0.2ng/ml)。1 例患者出现 Clavien-Dindo 分级>III 级并发症。

结论

DROP-IN 探头有助于实现机器人辅助 PSMA-RGS。该程序在技术上可行,可用于术中检测淋巴结或局部 PSMA 阳性 PCa 复发。

患者总结

一种名为 DROP-IN 探头的设备有助于在复发性前列腺癌患者中实现放射性示踪剂引导的微创机器人辅助手术。该程序有望改善前列腺癌病灶的术中识别和切除。

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