Establishing a Provincial Registry for Recurrent Prostate Cancer: Providing Access to PSMA PET/CT in Ontario, Canada

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.

Intraductal Prostate Cancer Affinity for Lymphatic-Predominant Metastases Through 18 F-DCFPyL‒Prostate-Specific Membrane Antigen‒Positron Emission Tomography/CT Scans in Pretreatment Prostate Cancer Patients

“…PSMA-PET/CT was performed at the treating physician's discretion. Our study was part of a research project where all patients were prospectively registered via a registrydthe PSMA-PET for Recurrent Prostate Cancer (PREP) registry 12 dthat was enacted in Ontario to provide access to the PSMA-PET technology, while also to gather information around utilization to guide future access in the Province. As part of the registry requirements all patients were required to have a negative conventional bone scan and CT scan before PSMA-PET.…”

Mesorectal nodal metastasis with seminal vesicle invasion in biochemically recurrent prostate cancer

“…PSMA-PET/CT was performed at the discretion of the treating physician. The study patients were prospectively enrolled in the PSMA-PET for Recurrent Prostate Cancer (PREP) provincial registry [2,5,13]. All lesions were assessed using the PROMISE classification.…”

Prostate-Specific Membrane Antigen PET-CT Imaging for the Staging of Prostate Cancer in Canada

“…60 As well, the production yield of cyclotron-produced 18F is higher than that of a 68Ga generator, 6 allowing for around 25 PET-CT exams a day. 34 While centralized production of PSMA radiopharmaceuticals using cyclotrons may provide greater production efficiency and cost-effectiveness when compared to generator-produced radiopharmaceuticals, 61 for provinces with PET-CT that rely on a single cyclotron (which is the case in 6 provinces), unplanned downtime due to technical problems or unanticipated maintenance can create a "single point of failure," which results in the cancellation of patient appointments. 18 Generators allow sites that do not have access to cyclotrons to have a supply of 68Ga PSMA.…”