Afaq Asim, Payne Heather, Davda Reena, Hines John, Cook Gary J R, Meagher Marie, Priftakis Dimitrios, Warbey Victoria S, Kelkar Anand, Orczyk Clement, Mitra Anita, Needleman Sarah, Ferris Michael, Mullen Greg, Bomanji Jamshed
Institute of Nuclear Medicine, University College London Hospitals, United Kingdom.
Radiotherapy Department, University College London Hospitals.
J Nucl Med. 2021 Mar 19;62(12):1727-34. doi: 10.2967/jnumed.120.257527.
To assess the safety and clinical impact of a novel, kit-based formulation of Ga-THP PSMA positron emission tomography/computed tomography (PET/CT) when used to guide the management of patients with prostate cancer (PCa). Patients were prospectively recruited in to one of: Group A: high-risk untreated prostate cancer; Gleason score >4+3, or PSA >20 ng/mL or clinical stage >T2c. Group B: biochemical recurrence (BCR) and eligible for salvage treatment after radical prostatectomy with two consecutive rises in prostate specific antigen (PSA) with a three month interval in between reads and final PSA >0.1 ng/mL or a PSA level >0.5 ng/mL. Group C: BCR with radical curative radiotherapy or brachytherapy at least three months prior to enrolment, and an increase in PSA level >2.0 ng/mL above the nadir level after radiotherapy or brachytherapy. Patients underwent evaluation with PET/CT 60 minutes following intravenous administration of 160±30 MBq of Ga-THP PSMA. Safety was assessed by means including vital signs, cardiovascular profile, serum haematology, biochemistry, urinalysis, PSA, and Adverse Events (AEs). A change in management was reported when the predefined clinical management of the patient altered as a result of Ga-THP PSMA PET/CT findings. Forty-nine patients were evaluated with PET/CT; 20 in Group A, 21 in Group B and 8 in Group C. No patients experienced serious AEs discontinued the study due to AEs, or died during the study. Two patients had Treatment Emergent AEs attributed to Ga-THP-PSMA (pruritus in one patient and intravenous catheter site rash in another). Management change secondary to PET/CT occurred in 42.9% of all patients; 30% in Group A, 42.9% in Group B and 75% in Group C. Ga-THP PSMA was safe to use with no serious AE and no AE resulting in withdrawal from the study. Ga-THP PSMA PET/CT changed the management of patients in 42.9% of the study population, comparable to studies using other PSMA tracers. These data form the basis of a planned Phase III study of Ga-THP PSMA in patients with prostate cancer.
评估一种基于试剂盒的新型镓-THP PSMA正电子发射断层扫描/计算机断层扫描（PET/CT）制剂在用于指导前列腺癌（PCa）患者管理时的安全性和临床影响。患者被前瞻性纳入以下其中一组：A组：高危未经治疗的前列腺癌； Gleason评分>4+3，或PSA>20 ng/mL或临床分期>T2c。B组：生化复发（BCR），在根治性前列腺切除术后符合挽救治疗条件，前列腺特异性抗原（PSA）连续两次升高，两次检测间隔三个月，且最终PSA>0.1 ng/mL或PSA水平>0.5 ng/mL。C组：在入组前至少三个月接受过根治性放疗或近距离放疗的BCR患者，放疗或近距离放疗后PSA水平较最低点升高>2.0 ng/mL。患者在静脉注射160±30 MBq镓-THP PSMA后60分钟接受PET/CT评估。通过生命体征、心血管状况、血清血液学、生物化学、尿液分析、PSA和不良事件（AE）等手段评估安全性。当患者的预定义临床管理因镓-THP PSMA PET/CT检查结果而改变时，报告管理变化情况。49例患者接受了PET/CT评估；A组20例，B组21例，C组8例。没有患者因严重AE停止研究，也没有患者在研究期间死亡。两名患者出现了归因于镓-THP-PSMA的治疗中出现的AE（一名患者出现瘙痒，另一名患者出现静脉导管部位皮疹）。PET/CT导致的管理变化在所有患者中占42.9%；A组为30%，B组为42.9%，C组为75%。镓-THP PSMA使用安全，无严重AE，也没有AE导致退出研究。镓-THP PSMA PET/CT在42.9%的研究人群中改变了患者的管理，与使用其他PSMA示踪剂的研究相当。这些数据构成了一项关于镓-THP PSMA在前列腺癌患者中的计划中的III期研究的基础。
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