Increasing availability of the Axumin-enhanced PET scan


Back in May this year we reported that the US Food and Drug Administration had approved a new type of imaging agent known as [18F]fluciclovine (Axumin®) for use in association with PET scans in men with recurrent prostate cancer that might have spread to other parts of the body, but which was not evident on older forms of scan.

It has taken the UK-based developer a little while to be able to make this imaging agent widely available in the US, but we are now aware that it is available in parts of Florida and in the Chicago area too (see here), so it seems that the test is now becoming reasonably accessible in most of the highly populated areas of the county, and the imaging agent itself is being manufactured here in the US as well.

One problem that we assume that the manufacturer is working on as a priority is that the test is not yet covered by all regional Medicare Administrative Contractors or (probably) by the majority of commercial insurance companies, and so patients need to be aware that there may be a significant out-of-pocket cost associated with this test at this time. Some relevant information about reimbursement (primarily for physicians and hospitals) can be found on the product web site.

Another way to be able to get this test done would be by seeing if one was eligible for participation in this clinical trial, currently enrolling patients at nine different centers in the USA. A similar trial is enrolling patients at six centers in the UK as well.

At present Axumin is approved exclusively for “imaging in men with suspected prostate cancer recurrence based on elevated blood prostate specific antigen (PSA) levels following prior treatment”. However, it seems clear to The “New” Prostate Cancer InfoLink that a future potential use for this test will be among men believed to be at risk for positive lymph nodes and/or micrometastasis at the time of initial diagnosis. There is a significant likelihood that this test would be a great deal better at identifying such patients than older bone scans, CT scans, and probably even multiparametric MRI scans too. However, it may take a little while before the company is able to demonstrate the effectiveness of [18F]fluciclovine-enhanced PET scanning in the work-up of such patients.

Another, smaller trial, at Emory University in Atlanta is exploring the application of this type of imaging in men with biopsy-proven primary or recurrent castration-resistant prostate cancer with skeletal and/or nodal involvement who are being treated with chemotherapy as a way to evaluate the success of their treatment.

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