Saperstein Lawrence, Rowe Steven P, Gorin Michael A, Pienta Kenneth J, Siegel Barry A, Morris Michael J, Baskaran Saradha, Stambler Nancy, DiPippo Vincent A, Denes Bela S
Department of Radiology and Biomedical Imaging, Yale School of Medicine, Connecticut, USA.
Department of Radiology, University of North Carolina School of Medicine, Chapel Hill, North Carolina, USA.
Prostate. 2025 Aug;85(11):1005-1015. doi: 10.1002/pros.24909. Epub 2025 May 4.
This study investigates the impact of hormone therapy (HT) on the diagnostic performance of F-piflufolastat PET/CT in OSPREY (NCT02981368) cohort B patients with recurrent or metastatic prostate cancer.
F-piflufolastat PET/CT was evaluated in OSPREY cohort B patients (n = 117 men) with elevated prostate-specific antigen (PSA) levels and suspected local recurrence or metastatic disease on baseline conventional imaging. Patients were stratified based on HT status, and sensitivity and positive predictive value (PPV) were determined for the subset of 93 patients with evaluable pathology. Baseline serum PSA and testosterone levels were determined within 30 days before dosing using standardized laboratory methods.
In OSPREY cohort B, 34.4% of patients (32/93) were on at least one concomitant HT with a median exposure duration of 15.5 months. The median baseline PSA and testosterone levels for patients on concurrent HT (n = 32) were 31.6 ng/mL and 9 ng/dL, respectively. For patients not on concurrent therapy (n = 61), median PSA and testosterone levels were 6.1 ng/mL and 317.35 ng/dL, respectively. The median sensitivity of F-piflufolastat PET/CT across three readers was 96.4% (95%CI: 80.8%-100%) in patients receiving concurrent HT and 95.4% (95%CI: 83.7%-99.6%) in patients not receiving concurrent HT. A modest increase in median PPV was observed in patients receiving concomitant HT (median of three readers: 90.0% [95%CI: 73.6, 97.3]) compared to patients not receiving concomitant therapy (median of three readers: 77.4% [95%CI: 66.1, 88.6]).
The diagnostic performance of F-piflufolastat PET/CT was unaffected by concomitant HT in OSPREY cohort B patients with recurrent and/or metastatic prostate cancer.
本研究调查了激素疗法（HT）对OSPREY（NCT02981368）队列B中复发或转移性前列腺癌患者F-匹氟唑他PET/CT诊断性能的影响。
对OSPREY队列B中前列腺特异性抗原（PSA）水平升高且基线传统影像学检查怀疑局部复发或转移性疾病的患者（n = 117名男性）进行F-匹氟唑他PET/CT评估。根据HT状态对患者进行分层，并对93例具有可评估病理学结果的患者亚组确定敏感性和阳性预测值（PPV）。在给药前30天内使用标准化实验室方法测定基线血清PSA和睾酮水平。
在OSPREY队列B中，34.4%的患者（32/93）正在接受至少一种联合HT治疗，中位暴露持续时间为15.5个月。接受联合HT治疗的患者（n = 32）的中位基线PSA和睾酮水平分别为31.6 ng/mL和9 ng/dL。未接受联合治疗的患者（n = 61）的中位PSA和睾酮水平分别为6.1 ng/mL和317.35 ng/dL。在接受联合HT治疗的患者中，三位阅片者的F-匹氟唑他PET/CT中位敏感性为96.4%（95%CI：80.8%-100%），在未接受联合HT治疗的患者中为95.4%（95%CI：83.7%-99.6%）。与未接受联合治疗的患者相比（三位阅片者的中位值：77.4% [95%CI：66.1, 88.6]），接受联合HT治疗的患者中位PPV有适度增加（三位阅片者的中位值：90.0% [95%CI：73.6, 97.3]）。
在OSPREY队列B中复发和/或转移性前列腺癌患者中，联合HT不影响F-匹氟唑他PET/CT的诊断性能。
