Leeds Teaching Hospitals NHS Trust, Leeds, United Kingdom; University of Leeds, Leeds, United Kingdom.
Leeds Teaching Hospitals NHS Trust, Leeds, United Kingdom.
Int J Radiat Oncol Biol Phys. 2020 Jun 1;107(2):316-324. doi: 10.1016/j.ijrobp.2020.01.050. Epub 2020 Feb 14.
Early and accurate localization of lesions in patients with biochemical recurrence (BCR) of prostate cancer may guide salvage therapy decisions. The present study, F-Fluciclovine PET/CT in biochemicAL reCurrence Of Prostate caNcer (FALCON; NCT02578940), aimed to evaluate the effect of F-fluciclovine on management of men with BCR of prostate cancer.
Men with a first episode of BCR after curative-intent primary therapy were enrolled at 6 UK sites. Patients underwent F-fluciclovine positron emission tomography/computed tomography (PET/CT) according to standardized procedures. Clinicians documented management plans before and after scanning, recording changes to treatment modality as major and changes within a modality as other. The primary outcome measure was record of a revised management plan postscan. Secondary endpoints were evaluation of optimal prostate specific antigen (PSA) threshold for detection, salvage treatment outcome assessment based on F-fluciclovine-involvement, and safety.
F-Fluciclovine was well tolerated in the 104 scanned patients (median PSA = 0.79 ng/mL). Lesions were detected in 58 out of 104 (56%) patients. Detection was broadly proportional to PSA level; ≤1 ng/mL, 1 out of 3 of scans were positive, and 93% scans were positive at PSA >2.0 ng/mL. Sixty-six (64%) patients had a postscan management change (80% after a positive result). Major changes (43 out of 66; 65%) were salvage or systemic therapy to watchful waiting (16 out of 66; 24%); salvage therapy to systemic therapy (16 out of 66; 24%); and alternative changes to treatment modality (11 out of 66, 17%). The remaining 23 out of 66 (35%) management changes were modifications of the prescan plan: most (22 out of 66; 33%) were adjustments to planned brachytherapy/radiation therapy to include a F-fluciclovine-guided boost. Where F-fluciclovine guided salvage therapy, the PSA response rate was higher than when F-fluciclovine was not involved (15 out of 17 [88%] vs 28 out of 39 [72%]).
F-Fluciclovine PET/CT located recurrence in the majority of men with BCR, frequently resulting in major management plan changes. Incorporating F-fluciclovine PET/CT into treatment planning may optimize targeting of recurrence sites and avoid futile salvage therapy.
早期、准确地定位生化复发（BCR）前列腺癌患者的病灶，可能有助于指导挽救性治疗决策。本研究（F-氟替曲沙 PET/CT 在前列腺癌生化复发中的应用（FALCON；NCT02578940）旨在评估 F-氟替曲沙在治疗 BCR 前列腺癌患者中的作用。
在英国的 6 个地点，纳入首次发生 BCR 的根治性治疗后患者。患者按照标准程序进行 F-氟替曲沙正电子发射断层扫描/计算机断层扫描（PET/CT）。临床医生在扫描前和扫描后记录管理计划，记录治疗方式的改变为主要改变，同一治疗方式内的改变为其他改变。主要终点是记录扫描后修改的管理计划。次要终点是评估最佳前列腺特异性抗原（PSA）检测阈值，基于 F-氟替曲沙参与评估挽救性治疗结果，以及安全性。
104 例接受扫描的患者中，F-氟替曲沙耐受良好（中位 PSA=0.79ng/ml）。58 例（56%）患者的病变得到了检测。检测与 PSA 水平呈广泛比例关系；PSA≤1ng/ml，3 次扫描中只有 1 次为阳性，PSA>2.0ng/ml 的扫描中 93%为阳性。66 例（64%）患者在扫描后发生了管理变化（阳性结果后 80%）。主要变化（66 例中有 43 例；65%）为挽救性或全身治疗观察等待（66 例中有 16 例；24%）；挽救性治疗转为全身治疗（66 例中有 16 例；24%）；治疗方式的替代变化（66 例中有 11 例；17%）。其余 23 例（35%）管理变化是对预先计划的修改：大多数（66 例中有 22 例；33%）是调整计划的近距离放疗/放疗，包括 F-氟替曲沙指导的增敏。在 F-氟替曲沙指导的挽救性治疗中，PSA 缓解率高于不涉及 F-氟替曲沙的情况（17 例中有 15 例[88%] vs.39 例中有 28 例[72%]）。
F-氟替曲沙 PET/CT 定位了大多数 BCR 患者的复发，常导致主要管理计划的改变。将 F-氟替曲沙 PET/CT 纳入治疗计划可能有助于优化复发部位的靶向治疗，并避免无效的挽救性治疗。
