PDF(Pubmed)
Abstract：
Prostate-specific membrane antigen (PSMA) is expressed by the majority of clinically significant prostate adenocarcinomas, and patients with target-positive disease can easily be identified by PSMA PET imaging. Promising results with PSMA-targeted radiopharmaceutical therapy have already been obtained in early-phase studies using various combinations of targeting molecules and radiolabels. Definitive evidence of the safety and efficacy of [177Lu]Lu-PSMA-617 in combination with standard-of-care has been demonstrated in patients with metastatic castration-resistant prostate cancer, whose disease had progressed after or during at least one taxane regimen and at least one novel androgen-axis drug. Preliminary data suggest that 177Lu-PSMA-radioligand therapy (RLT) also has high potential in additional clinical situations. Hence, the radiopharmaceuticals [177Lu]Lu-PSMA-617 and [177Lu]Lu-PSMA-I&T are currently being evaluated in ongoing phase 3 trials. The purpose of this guideline is to assist nuclear medicine personnel, to select patients with highest potential to benefit from 177Lu-PSMA-RLT, to perform the procedure in accordance with current best practice, and to prepare for possible side effects and their clinical management. We also provide expert advice, to identify those clinical situations which may justify the off-label use of [177Lu]Lu-PSMA-617 or other emerging ligands on an individual patient basis.
摘要：
前列腺特异性膜抗原（PSMA）由大多数具有临床意义的前列腺腺癌表达，目标阳性疾病患者可以很容易地通过PSMAPET成像识别。在使用靶向分子和放射性标记的各种组合的早期研究中已经获得了PSMA靶向的放射性药物治疗的有希望的结果。[177Lu]Lu-PSMA-617联合标准治疗的安全性和有效性的明确证据已在转移性去势抵抗性前列腺癌患者中得到证实，其疾病在至少一种紫杉烷方案和至少一种新型雄激素轴药物后或期间进展。初步数据表明，177Lu-PSMA放射性配体疗法（RLT）在其他临床情况下也具有很高的潜力。因此，放射性药物[177Lu]Lu-PSMA-617和[177Lu]Lu-PSMA-I&T目前正在进行的3期试验中进行评估.本准则的目的是协助核医学人员,选择最有可能从177Lu-PSMA-RLT获益的患者，根据当前的最佳实践执行该程序，并为可能的副作用及其临床管理做好准备。我们还提供专家建议，以确定可能证明在个体患者基础上使用[177Lu]Lu-PSMA-617或其他新出现的配体的临床情况。
