Loeff Cato C, van Gemert Willemijn, Privé Bastiaan M, van Oort Inge M, Hermsen Rick, Somford Diederik M, Nagarajah James, Heijmen Linda, Janssen Marcel J R
Department of Radiology and Nuclear Medicine, Radboud University Medical Center, Radboud Institute for Health Sciences, PO Box 9101, 6500 HB, Nijmegen, The Netherlands.
Department of Radiation Oncology, Erasmus Medical Center, Cancer Institute, Rotterdam, The Netherlands.
EJNMMI Rep. 2024 Nov 27;8(1):38. doi: 10.1186/s41824-024-00228-2.
The objective of this study was to compare the detection rates of [F]PSMA-1007 and [F]Fluciclovine in early biochemical recurrence (BCR) of prostate cancer, i.e. with low prostate-specific antigen (PSA) levels (0.2-5.0 µg/L).
This was a prospective, single-center (Radboudumc; Nijmegen, The Netherlands), comparative phase II diagnostic imaging study (NCT04239742). The main inclusion criteria were histologically proven adenocarcinoma of the prostate, BCR after radical treatment with two consecutive (rising) PSA values (0.2-5.0 µg/L). Patients underwent both [F]PSMA-1007 PET/CT and [F]Fluciclovine PET/CT within two weeks. Both scans were blindly scored by three independent nuclear medicine physicians. Hereafter, a result per scan and region was generated by consensus. The primary outcome was to compare the detection rate on a patient and region level. Secondary objectives were to determine detection rate stratified for PSA value, inter-reader agreement, and SUV measurements. For lesion confirmation a composite reference score was established using follow-up data.
Data of fifty patients were included, median age of 71 (IQR: 67-74) years and median PSA value of 0.38 (IQR: 0.30-1.55) µg/L. Detection rates were 68% (34/50) for [F]PSMA-1007 and 42% (21/50) for [F]Fluciclovine on a patient level (p < 0.001). Detection rates stratified for PSA value of [F]PSMA-1007 in comparison with [F]Fluciclovine were for PSA 0.2-0.5 µg/L; 60.7% versus 25.0% (p = 0.002); and for PSA ≥ 0.5 µg/L; 77.3% versus 63.6% (p = 0.250). There was a trend for higher inter-reader agreement with [F]PSMA-1007. SUV (p < 0.001) was significantly higher for [F]PSMA-1007 in comparison to [F]Fluciclovine.
In patients with early BCR of prostate cancer after radical surgery or radiotherapy, [F]PSMA-1007 demonstrated a significantly higher detection rate than [F]Fluciclovine. This is particularly relevant since earlier and more accurate detection of a BCR can guide salvage therapy into a tailored strategy which may improve outcomes.
ClinicalTrials.gov, NCT04239742. Registered 02 January 2020, https://clinicaltrials.gov/study/NCT04239742 .
本研究的目的是比较[F]PSMA - 1007和[F]氟西洛维在前列腺癌早期生化复发（BCR）中的检出率，即前列腺特异性抗原（PSA）水平较低（0.2 - 5.0μg/L）时的检出率。
这是一项前瞻性、单中心（拉德堡德大学医学中心；荷兰奈梅亨）的比较性II期诊断成像研究（NCT04239742）。主要纳入标准为经组织学证实的前列腺腺癌，根治性治疗后出现BCR且连续两次（上升）PSA值（0.2 - 5.0μg/L）。患者在两周内接受了[F]PSMA - 1007 PET/CT和[F]氟西洛维PET/CT检查。两位扫描均由三位独立的核医学医生进行盲法评分。此后，通过共识得出每次扫描和每个区域的结果。主要结局是比较患者和区域层面的检出率。次要目标是确定按PSA值分层的检出率、阅片者间的一致性以及SUV测量值。为了进行病变确认，使用随访数据建立了综合参考评分。
纳入了50例患者的数据，中位年龄为71岁（四分位间距：67 - 74岁），中位PSA值为0.38μg/L（四分位间距：0.30 - 1.55μg/L）。在患者层面，[F]PSMA - 1007的检出率为68%（34/50），[F]氟西洛维的检出率为42%（21/50）（p < 0.001）。与[F]氟西洛维相比，[F]PSMA - 1007按PSA值分层的检出率为：PSA 0.2 - 0.5μg/L时，分别为60.7%和25.0%（p = 0.002）；PSA≥0.5μg/L时，分别为77.3%和63.6%（p = 0.250）。[F]PSMA - 1007的阅片者间一致性有更高的趋势。与[F]氟西洛维相比，[F]PSMA - 1007的SUV（p < 0.001）显著更高。
在根治性手术或放疗后前列腺癌早期BCR患者中，[F]PSMA - 1007的检出率显著高于[F]氟西洛维。这一点尤为重要，因为更早、更准确地检测BCR可以指导挽救性治疗制定个性化策略，从而可能改善治疗结果。
ClinicalTrials.gov，NCT04239742。于2020年1月2日注册，https://clinicaltrials.gov/study/NCT04239742 。
