Abstract：
BACKGROUND: The use of clinical parameters, including prebiopsy magnetic resonance imaging (MRI), to decide between active surveillance (AS) and active therapy for prostate cancer (PCa) leads to imperfect selection. Additional prostate-specific membrane antigen (PSMA) positron emission tomography/computed tomography (PET/CT) imaging may improve risk stratification.
OBJECTIVE: To study risk stratification and patient selection for AS with the addition of PSMA PET/CT to standard practice.
METHODS: A single-centre prospective cohort study (NL69880.100.19) enrolled patients recently diagnosed with PCa who started AS. At diagnosis, all participants had undergone prebiopsy MRI and targeted biopsy for visualised lesions. Patients underwent an additional [68Ga]-PSMA PET/CT and targeted biopsy of all PSMA lesions with a maximum standardised uptake value (SUVmax) of ≥4 not covered by previous biopsies.
METHODS: The primary outcome was the number needed to scan (NNS) to detect one patient with upgrading. The study was powered to detect an NNS of 10. Regarding secondary outcomes, univariate logistic regressions analyses were performed on all patients and on the patients who received additional PSMA targeted biopsies on the likelihood of upgrading.
CONCLUSIONS: A total of 141 patients were included. Additional PSMA targeted biopsies were performed in 45 (32%) patients. In 13 (9%) patients, upgrading was detected: nine grade group (GG) 2, two GG 3, one GG 4, and one GG 5. The NNS was 11 (95% confidence interval 6-18). Of all participants, PSMA PET/CT and targeted biopsies yielded upgrading most frequently in patients with negative MRI (Prostate Imaging Reporting and Data System [PI-RADS] 1-2). Of patients who received additional PSMA targeted biopsies, upgrading was most frequently found in those with higher prostate-specific antigen density and negative MRI. Limitations included the lack of comparison with standard repeat biopsy, no central review of MRI, and possibility of biopsy sampling error.
CONCLUSIONS: PSMA PET/CT can further improve PCa risk stratification and selection for AS patients diagnosed after MRI and targeted biopsies.
RESULTS: Prostate-specific membrane antigen positron emission tomography/computed tomography and additional targeted prostate biopsies can identify more aggressive prostate cancer cases previously missed in patients recently started with expectant management for favourable-risk prostate cancer.
OBJECTIVE: To study risk stratification and patient selection for AS with the addition of PSMA PET/CT to standard practice.
METHODS: A single-centre prospective cohort study (NL69880.100.19) enrolled patients recently diagnosed with PCa who started AS. At diagnosis, all participants had undergone prebiopsy MRI and targeted biopsy for visualised lesions. Patients underwent an additional [68Ga]-PSMA PET/CT and targeted biopsy of all PSMA lesions with a maximum standardised uptake value (SUVmax) of ≥4 not covered by previous biopsies.
METHODS: The primary outcome was the number needed to scan (NNS) to detect one patient with upgrading. The study was powered to detect an NNS of 10. Regarding secondary outcomes, univariate logistic regressions analyses were performed on all patients and on the patients who received additional PSMA targeted biopsies on the likelihood of upgrading.
CONCLUSIONS: A total of 141 patients were included. Additional PSMA targeted biopsies were performed in 45 (32%) patients. In 13 (9%) patients, upgrading was detected: nine grade group (GG) 2, two GG 3, one GG 4, and one GG 5. The NNS was 11 (95% confidence interval 6-18). Of all participants, PSMA PET/CT and targeted biopsies yielded upgrading most frequently in patients with negative MRI (Prostate Imaging Reporting and Data System [PI-RADS] 1-2). Of patients who received additional PSMA targeted biopsies, upgrading was most frequently found in those with higher prostate-specific antigen density and negative MRI. Limitations included the lack of comparison with standard repeat biopsy, no central review of MRI, and possibility of biopsy sampling error.
CONCLUSIONS: PSMA PET/CT can further improve PCa risk stratification and selection for AS patients diagnosed after MRI and targeted biopsies.
RESULTS: Prostate-specific membrane antigen positron emission tomography/computed tomography and additional targeted prostate biopsies can identify more aggressive prostate cancer cases previously missed in patients recently started with expectant management for favourable-risk prostate cancer.
摘要：
背景：临床参数的使用，包括活检前磁共振成像（MRI），在主动监测（AS）和主动治疗前列腺癌（PCa）之间做出决定会导致选择不完善。额外的前列腺特异性膜抗原（PSMA）正电子发射断层扫描/计算机断层扫描（PET/CT）成像可以改善风险分层。
目的：在标准实践中增加PSMAPET/CT，研究AS的风险分层和患者选择。
方法：一项单中心前瞻性队列研究（NL69880.100.19）纳入了最近诊断为PCa并开始AS的患者。诊断时,所有参与者均接受了活检前MRI和可视化病灶的靶向活检.患者接受了额外的[68Ga]-PSMAPET/CT，并对所有PSMA病变进行了靶向活检，最大标准化摄取值（SUVmax）≥4，以前的活检未涵盖。
方法：主要结果是需要扫描的人数（NNS）来检测一名升级患者。该研究有能力检测NNS为10。关于次要结果，我们对所有患者和接受额外PSMA靶向活检的患者进行了单变量逻辑回归分析,以确定升级的可能性.
结论：共纳入141例患者。在45例（32％）患者中进行了额外的PSMA靶向活检。在13名（9%）患者中，检测到升级：九级组（GG）2，两个GG3，一个GG4和一个GG5。NNS为11(95%置信区间6-18)。在所有参与者中，PSMAPET/CT和靶向活检在MRI阴性的患者中最常见（前列腺成像报告和数据系统[PI-RADS]1-2）。在接受额外PSMA靶向活检的患者中，升级最常见于前列腺特异性抗原密度较高且MRI阴性的患者.局限性包括缺乏与标准重复活检的比较，没有磁共振成像的中央检查，和活检抽样误差的可能性。
结论：PSMAPET/CT可进一步改善经MRI和靶向活检诊断的AS患者的PCa风险分层和选择。
结果：前列腺特异性膜抗原正电子发射断层扫描/计算机断层扫描和额外的靶向前列腺活检可以识别更多的侵袭性前列腺癌病例，这些病例以前在最近开始对有利风险前列腺癌进行预期管理的患者中错过。
目的：在标准实践中增加PSMAPET/CT，研究AS的风险分层和患者选择。
方法：一项单中心前瞻性队列研究（NL69880.100.19）纳入了最近诊断为PCa并开始AS的患者。诊断时,所有参与者均接受了活检前MRI和可视化病灶的靶向活检.患者接受了额外的[68Ga]-PSMAPET/CT，并对所有PSMA病变进行了靶向活检，最大标准化摄取值（SUVmax）≥4，以前的活检未涵盖。
方法：主要结果是需要扫描的人数（NNS）来检测一名升级患者。该研究有能力检测NNS为10。关于次要结果，我们对所有患者和接受额外PSMA靶向活检的患者进行了单变量逻辑回归分析,以确定升级的可能性.
结论：共纳入141例患者。在45例（32％）患者中进行了额外的PSMA靶向活检。在13名（9%）患者中，检测到升级：九级组（GG）2，两个GG3，一个GG4和一个GG5。NNS为11(95%置信区间6-18)。在所有参与者中，PSMAPET/CT和靶向活检在MRI阴性的患者中最常见（前列腺成像报告和数据系统[PI-RADS]1-2）。在接受额外PSMA靶向活检的患者中，升级最常见于前列腺特异性抗原密度较高且MRI阴性的患者.局限性包括缺乏与标准重复活检的比较，没有磁共振成像的中央检查，和活检抽样误差的可能性。
结论：PSMAPET/CT可进一步改善经MRI和靶向活检诊断的AS患者的PCa风险分层和选择。
结果：前列腺特异性膜抗原正电子发射断层扫描/计算机断层扫描和额外的靶向前列腺活检可以识别更多的侵袭性前列腺癌病例，这些病例以前在最近开始对有利风险前列腺癌进行预期管理的患者中错过。
