An Approach to New Oncologic PET Agent Development

Objectives: Review the development pathway for oncologic PET agents. Discuss regulations, clinical trial design and good clinical practices. Provide ¹⁸F-DCFPyL as an example.

Methods: Review of existing literature in the field.

Results: The use of PET for staging and subsequent treatment strategy has been validated and established in many cancers. Indeed, it has been incorporated into clinical guidelines and has a recognized role in selecting appropriate treatment. However, the strength of PET lies in our ability to design agents that are capable of identifying disease specific targets. Our ability to bring these agents into clinical practice, particularly in today’s resource constrained environment, is key if patient care and outcomes are to be improved. Knowledge of the process a new PET agent follows to go from bench to bedside is helpful, both for members of our scientific and medical community as well as for our patients and regulators. The process followed for ¹⁸F-DCFPyL to go from inception to imaging in men with prostate cancer will serve as an illustration. Although our focus will be on Canadian regulations, we will compare this with current practice in America.

Conclusion: The pathway followed for oncologic PET agent development is complex. Ultimately, if we wish to expedite the process, we must first understand it. Research Support: