Abstract
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.
Highlights
Ontario has a publicly funded health care system with a proven track record in clinical trials, health services research and evidence-based medicine [1]
We describe the organization and deployment of the Prostate Specific Membrane Antigen (PSMA) positron emission tomography/computed tomography (PET/CT) (PREP) Registry throughout the province to provide access for men with
The protocol provided for investigation of PSMA positron emission tomography (PET)/CT across a variety of clinical scenarios in the setting of prostate cancer recurrence after primary therapy, after PET/CT directed therapy, or through an access cohort for PET/CT-assisted decision making in scenarios not covered by the other cohorts
Summary
Ontario has a publicly funded health care system with a proven track record in clinical trials, health services research and evidence-based medicine [1]. The registries facilitated real-world evaluation and evidence-building in the Ontario context for specific clinical indications, enabling access to PET scanning for patients while collecting a minimum dataset (such as pre- and post-PET stage, pre- and post-scan intended treatment) that could be linked to provincial administrative databases to determine a change in management decisions, actual treatment delivered, and patient outcomes after the provision of PET [3]. While praised as an evidence-based approach to ensure funded interventions demonstrate clear benefits to patients, this model has been criticized by others as perhaps too rigorous (unreasonable to expect diagnostic tests to show impact on clinical outcomes where downstream management strategies might diverge quickly confounding the influence of imaging on outcomes) and that the time it takes to acquire high-level evidence may limit patient access to new PET technologies [2]
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