Rais-Bahrami Soroush, Fleming Mark, Gartrell Benjamin, Lavely William C, Chau Albert, Davis Phillip, Schuster David M
Department of Urology, University of Alabama at Birmingham Heersink School of Medicine, Birmingham, Alabama.
Department of Radiology, University of Alabama at Birmingham Heersink School of Medicine, Birmingham, Alabama.
Adv Radiat Oncol. 2024 Jul 14;9(9):101571. doi: 10.1016/j.adro.2024.101571. eCollection 2024 Sep.
Although African American (AA) patients are disproportionately affected by prostate cancer, they are often underrepresented in oncology clinical trials. The SPOTLIGHT study (NCT04186845) assessed the novel diagnostic positron emission tomography radiopharmaceutical, F-flotufolastat (F-rhPSMA-7.3), in patients with recurrent prostate cancer. The proportion of AA patients enrolled in SPOTLIGHT (17%) was greater than typically enrolled in oncology trials (8.5%) and was representative of the US population (14%). This post hoc analysis of SPOTLIGHT evaluates the diagnostic performance of F-flotufolastat in AA patients.
Patients underwent positron emission tomography/computed tomography 50 to 70 minutes after intravenous administration of 296 MBq F-flotufolastat. Three blinded readers evaluated all images, with the majority read (agreement of ≥2 readers) result reported here. Standard of truth (SoT) was established with histopathology or correlative imaging. Data from AA patients were evaluated to determine the F-flotufolastat overall detection rate (DR), positive predictive value (PPV), and verified DR (VDR). VDR (SoT-verified) is equivalent to DR × PPV.
In total, 61 of 366 (17%) patients were AAs. Although baseline characteristics were broadly similar, fewer AA patients (56%) had undergone prostatectomy than non-AA patients (82%). The patient-level DR was 93% (57/61) in AA patients, increasing from 67% at prostate-specific antigen <0.5 ng/mL to 100% at prostate-specific antigen ≥10 ng/mL. Patient-level DR was marginally lower in all other patients (87%, 264/305). However, when stratifying by prior treatment, DRs were similar across ethnic groups in postprostatectomy patients, but in patients with intact prostates, AA patients had higher prostate DR than non-AA patients. SoT-verification (predominantly with conventional imaging [79%]) gave a VDR of 64% and PPV of 68% in AA patients, versus 55% and 64%, respectively, in all other patients.
F-Flotufolastat DRs were marginally higher in AA patients than in all other patients enrolled in SPOTLIGHT. High VDR and PPV were also achieved in AA patients from across all participating centers, indicating the broad applicability of newly US Food and Drug Administration-approved F-flotufolastat to the US population as a whole.
尽管非裔美国（AA）患者受前列腺癌的影响尤为严重，但他们在肿瘤学临床试验中的代表性往往不足。SPOTLIGHT研究（NCT04186845）评估了新型诊断性正电子发射断层扫描放射性药物F-氟托法司他（F-rhPSMA-7.3）在复发性前列腺癌患者中的应用。参与SPOTLIGHT研究的AA患者比例（17%）高于肿瘤学试验中的典型比例（8.5%），且代表了美国人群（14%）。这项SPOTLIGHT研究的事后分析评估了F-氟托法司他在AA患者中的诊断性能。
患者在静脉注射296 MBq F-氟托法司他后50至70分钟接受正电子发射断层扫描/计算机断层扫描。三位盲法阅片者评估所有图像，此处报告的是多数阅片结果（≥2位阅片者达成一致）。通过组织病理学或相关影像学检查确定真值标准（SoT）。对AA患者的数据进行评估，以确定F-氟托法司他的总体检测率（DR）、阳性预测值（PPV）和验证后的DR（VDR）。VDR（经SoT验证）等于DR×PPV。
366例患者中共有61例（17%）为AA患者。尽管基线特征大致相似，但接受前列腺切除术的AA患者（56%）少于非AA患者（82%）。AA患者的患者层面DR为93%（57/61），在前列腺特异性抗原<0.5 ng/mL时为67%，在前列腺特异性抗原≥10 ng/mL时增至100%。所有其他患者的患者层面DR略低（87%，264/305）。然而，按既往治疗分层时，前列腺切除术后患者各种族间的DR相似，但在前列腺完整的患者中，AA患者的前列腺DR高于非AA患者。SoT验证（主要采用传统影像学检查[79%]）显示，AA患者的VDR为64%，PPV为68%，而所有其他患者的VDR和PPV分别为55%和64%。
在参与SPOTLIGHT研究的患者中，AA患者F-氟托法司他的DR略高于所有其他患者。所有参与中心的AA患者均实现了较高的VDR和PPV，表明美国食品药品监督管理局新批准的F-氟托法司他对美国全体人群具有广泛适用性。
