Young Sympascho, Metser Ur, Sistani Golmehr, Langer Deanna L, Bauman Glenn
London Regional Cancer Program, Department of Oncology, Western University and London Health Sciences Centre, London, ON, Canada.
Joint Department of Medical Imaging, Princess Margaret Hospital, University Health Network, Mount Sinai Hospital, Women's College Hospital and University of Toronto, Toronto, ON, Canada.
Front Oncol. 2021 Aug 2;11:722430. doi: 10.3389/fonc.2021.722430. eCollection 2021.
Prostate Specific Membrane Antigen (PSMA) positron emission tomography/computed tomography (PET/CT) is becoming established as a standard of care for the (re)staging of high-risk primary and prostate cancer recurrence after primary therapy. Despite the favorable performance of this imaging modality with high accuracy in disease detection, the availability of PSMA PET/CT varies across jurisdictions worldwide due to variability in the selection of PSMA PET/CT agent, regulatory approvals and funding. In Canada, PSMA based radiopharmaceuticals are still considered investigational new drug (IND), creating limitations in the deployment of these promising imaging agents. While regulatory approval rests with Health Canada, as a single payer health system, funding for Health Canada approved drugs and devices is decided by Provincial Health Ministries. Ontario Health (Cancer Care Ontario) (OH-CCO) is the agency of the Ministry of Health (MOH) in Ontario responsible for making recommendations to the MOH around the organization and funding of cancer services within Ontario (population of 15 million), and the PET Steering Committee of OH-CCO is responsible for providing recommendations on the introduction of new PET radiopharmaceuticals and indications. For Health Canada approved PET radiopharmaceuticals like 18F-FDG, OH-CCO (on behalf of the MOH) provides coverage based on levels of evidence and specific PET Registries are established to aid in real-world evidence collection to inform OH-CCO regarding emerging PET applications. In the case of PSMA PET/CT, adapting this model to an IND PSMA PET/CT agent, 18F-DCFPyL, necessitated the creation of a hybrid Registry-Study model to leverage the existing OH-CCO Registry structure while respecting the need for a Health Canada Clinical Trials Application (CTA) for the deployment of this agent in the province. Within the first 2 years of the registry, over 1700 men have been imaged resulting in a change in management (compared to pre-PET management plans) in over half of the men imaged. In this article, we describe the organization and deployment of the PSMA PET/CT (PREP) Registry throughout the province to provide access for men with suspected prostate cancer recurrence along with key stakeholder perspectives and preliminary results.
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）正逐渐成为高危原发性前列腺癌及原发治疗后前列腺癌复发（再）分期的护理标准。尽管这种成像方式在疾病检测方面具有较高的准确性，表现良好，但由于PSMA PET/CT剂的选择、监管批准和资金等方面存在差异，PSMA PET/CT在全球各司法管辖区的可及性各不相同。在加拿大，基于PSMA的放射性药物仍被视为研究性新药（IND），这限制了这些有前景的成像剂的应用。虽然监管批准由加拿大卫生部负责，但作为单一支付方的医疗系统，加拿大卫生部批准的药品和设备的资金由省级卫生部决定。安大略省卫生厅（安大略癌症护理厅）（OH-CCO）是安大略省卫生部（MOH）的机构，负责就安大略省（1500万人口）癌症服务的组织和资金向卫生部提出建议，OH-CCO的PET指导委员会负责就新PET放射性药物的引入和适应症提供建议。对于加拿大卫生部批准的PET放射性药物，如18F-FDG，OH-CCO（代表卫生部）根据证据水平提供覆盖范围，并建立了特定的PET登记处，以协助收集真实世界的证据，为OH-CCO提供有关新兴PET应用的信息。对于PSMA PET/CT，将该模式应用于IND的PSMA PET/CT剂18F-DCFPyL时，需要创建一种混合登记-研究模式，以利用现有的OH-CCO登记结构，同时尊重在该省部署该剂需要加拿大卫生部临床试验申请（CTA）这一需求。在登记的头两年内，超过1700名男性接受了成像检查，超过一半接受成像检查的男性的治疗管理（与PET检查前的管理计划相比）发生了变化。在本文中，我们描述了全省PSMA PET/CT（PREP）登记处的组织和部署情况，以便为疑似前列腺癌复发的男性提供检查机会，同时介绍关键利益相关者的观点和初步结果。
