German Cancer Research Center and Department of Nuclear Medicine, Universitätsklinikum Heidelberg, Heidelberg, Germany.
Department of Nuclear Medicine, |Universitätsklinikum Essen, Essen, Germany.
Eur J Nucl Med Mol Imaging. 2019 Nov;46(12):2536-2544. doi: 10.1007/s00259-019-04485-3. Epub 2019 Aug 22.
Prostate-specific membrane antigen (PSMA) is expressed in most prostate cancers and can be identified by PSMA-ligand imaging, which has already become clinically accepted in several countries in- and outside Europe. PSMA-directed radioligand therapy (PSMA-RLT) with Lutetium-177 (Lu-PSMA) is currently undergoing clinical validation. Retrospective observational data have documented favourable safety and striking clinical responses. Recent results from a prospective clinical trial (phase II) have been published confirming high response rates, low toxicity and reduction of pain in metastatic castration-resistant prostate cancer (mCRPC) patients who had progressed after conventional treatments. Such patients typically survive for periods less than 1.5 years. This has led some facilities to adopt compassionate or unproven use of this therapy, even in the absence of validation within a randomised-controlled trial. As a result, a consistent body of evidence exists to support efficacy and safety data of this treatment. The purpose of this guideline is to assist nuclear medicine specialists to deliver PSMA-RLT as an "unproven intervention in clinical practice", in accordance with the best currently available knowledge.
前列腺特异性膜抗原（PSMA）在大多数前列腺癌中表达，可以通过 PSMA-配体成像来识别，该方法已在欧洲内外的多个国家得到临床认可。镥-177（Lu-PSMA）的 PSMA 靶向放射性配体治疗（PSMA-RLT）目前正在进行临床验证。回顾性观察数据记录了良好的安全性和显著的临床反应。最近一项前瞻性临床试验（二期）的结果已经发表，证实了高反应率、低毒性和转移性去势抵抗性前列腺癌（mCRPC）患者疼痛减轻，这些患者在常规治疗后进展。这些患者的平均生存时间不到 1.5 年。这导致一些医疗机构采用同情或未经证实的使用这种疗法，即使在没有随机对照试验验证的情况下也是如此。因此，存在大量证据支持这种治疗的疗效和安全性数据。本指南的目的是根据现有最佳知识，协助核医学专家将 PSMA-RLT 作为“临床实践中的未经证实干预措施”进行应用。
