为评估新型放射性标记小分子177Lu-PNT2002联合立体定向体放射治疗（SBRT）与单独SBRT在少量复发性激素敏感性前列腺癌（mHSPC）男性患者的转移病灶中的疗效，在控制变量的开放标签、随机分层、两臂、单中心、2期试验中，比较新辅助用药177Lu-PNT2002加SBRT和单独SBRT在治疗mHSPC患者中的疗效和安全性。主要符合条件包括通过核医学专家审查的PSMA正电子发射计算机断层扫描（PET/CT）中发现的1-5个病变，主要排除标准包括去势抵抗性疾病、新发原发性多灶转移性疾病和试验入组前6个月内接受的雄激素剥夺治疗（ADT）。该试验旨在招募100例患者，以1:1比例随机分配至两个治疗组之一。对照组患者接受SBRT治疗所有疾病部位。实验组患者接受新辅助用药177Lu-PNT2002（6.8 GBq）的2个周期，间隔6-8周，随后在4-6周内进行PSMA PET/CT检查，并在1-2周后按个体化剂量进行SBRT治疗所有疾病部位。主要终点是无进展生存期。次要终点包括影像和基于PSA的进展、急性和晚期医师评分毒性、患者报告的生活质量、ADT无进展生存期、进展时间、总生存期、局部区域控制和反应持续时间。该研究的招募工作于2022年9月开始。将177Lu-PNT2002添加到仅靶向转移治疗中，可能可以进一步延缓疾病进展。该2期试验的结果将首次以随机方式确定177Lu-PNT2002在mHSPC患者中与SBRT结合的附加益处。本文受版权保护。保留所有权利。

To assess the efficacy of 177 Lu-PNT2002, a novel radiolabeled small molecule that binds with high affinity to prostate-specific membrane antigen (PSMA), in combination with stereotactic body radiotherapy (SBRT) to all sites of metastasis vs. SBRT alone, in men with oligorecurrent metastatic hormone sensitive prostate cancer (mHSPC).The 177 Lutetium-PSMA Neoadjuvant to Ablative Radiotherapy for Oligorecurrent Prostate Cancer (LUNAR) trial is an open-label, randomized, stratified, two-arm, single-center, phase 2 trial to compare the efficacy and safety of neoadjuvant 177 Lu-PNT2002 plus SBRT versus SBRT alone in men with oligorecurrent mHSPC. Key eligibility criteria include 1-5 lesions identified on a PSMA positron emission tomography (PET)/computed tomography (CT) scan centrally reviewed by a board-certified nuclear medicine physician. Key exclusion criteria include castrate-resistant disease, de novo oligometastatic disease and receipt of androgen deprivation therapy (ADT) within 6 months of trial enrollment. The trial aims to enroll 100 patients who will be centrally randomized to one of the two treatment arms, in a 1:1 ratio. Patients in the control arm receive SBRT to all sites of disease. Patients in the experimental arm receive 2 cycles of neoadjuvant 177 Lu-PNT2002 (6.8 GBq) 6-8 weeks apart, followed by an interval PSMA PET/CT in 4-6 weeks and dose-adapted SBRT to all sites of disease 1-2 weeks later. The primary endpoint is progression-free survival. Secondary endpoints are radiographic and PSA-based progression, acute and late physician-scored toxicity, patient-reported quality of life, ADT-free survival, time to progression, overall survival, locoregional control, and duration of response. Enrolment in the study commenced in September, 2022.The addition of 177 Lu-PNT2002 to metastasis-directed therapy alone may potentially further forestall disease progression. The results of this phase 2 trial will determine, for the first time in a randomized fashion, the added benefit of 177 Lu-PNT2002 to SBRT in patients with oligorecurrent mHSPC.This article is protected by copyright. All rights reserved.