Because the new imaging agent known as [18F]fluciclovine (Axumin®) is the only such imaging agent approved for use in the US — other than the [11C]choline imaging agent (use of which is limited to the Mayo Clinic) — we have been monitoring access to this new agent with some interest.
Whenever any new agent — whether an imaging agent or a new drug — is approved by the US Food and Drug Administration (FDA), the next step for the manufacturer to ensure that they can meet demand for the product, and work hard to make it widely available throughout 50 states and thousands of cities. This is no small task.
Blue Earth (the manufacturer) has partnered with Siemens’ PETNET Solutions (as the distributor) to make Axumin as widely available as possible as fast as this can be managed at PET scanning centers across America. However, this is an ongoing process and availability will continue to evolve over the next 6 to 12 months or so.
For patients interested in access to this type of imaging, at present, your best resource for finding an Axumin PET scan location near you is to contact the manufacturer’s medical information line at (855) 298-6461, and then dial 3 on the automated information system. They are open from 9:00 a.m. to 5:00 p.m. Eastern time, except for holidays.
With respect to insurance reimbursement, we understand that:
- Medicare is paying for this scan in men with recurrent prostate cancer and you can get more relevant information if you click here.
- For frequently asked questions about reimbursement for the Axumin PET scan, you can try clicking here.
- This test is not approved for newly diagnosed prostate cancer patients, and so neither Medicare nor commercial insurers will pay for this test in such patients because it hasn’t been studied in newly diagnosed patients.
- You can always check with the manufacturer’s medical information line (see above) to see if they have information about your particular insurance provider and whether they are covering the costs of this test yet, because that may be changing over time.
To be precise, the Axumin-enhanced PET scan is currently indicated by the FDA exclusively for “positron emission tomography (PET) imaging in men with suspected prostate cancer recurrence based on elevated blood prostate specific antigen (PSA) levels following prior treatment” (click here to get the details). Although it may be possible to use the Axumin scan to identify other types of cancer, it is not currently approved for any other use except recurrent prostate cancer, so if you have another type of cancer as well as recurrent prostate cancer, you should make sure that your doctors understand this if/when you get such a scan.
Patients should also be aware that experience in the use of the Axumin-enhanced PET scan can be important with respect to image quality and the interpretation of such images. At this point in time it is almost certainly wise to ask about the number of Axumin-enhanced PET scans that any particular center has done to date and the experience of the relevant radiologist or nuclear medicine specialist in the interpretation of such scan results.
Note: This commentary has been written for The “New” Prostate Cancer InfoLink by Jan Manarite, the Executive Vice President of Prostate Cancer International.
Filed under: Living with Prostate Cancer, Uncategorized | Tagged: Axumin, imaging, PET, scan, [18F]fluciclovine |
THE "NEW" PROSTATE CANCER INFOLINK 
OK, so you get an [11C]choline- or an Axumin-enhanced PET scan. You find one or a few positive lymph nodes.
— Your first treatment was radiation; good chance you no longer can get a lymph node dissection because of the prior treatment.
— Your first treatment was surgery. You have the lymph node(s) removed. Now what? the cancer has already spread; it is beyond the lymph node(s) you just removed. You are just delaying further progression by a few months.
At this point, a cure no longer is possible, correct?
Wolfram:
Ummm … Not exactly correct. No.
(1) If you were originally treated with radiation to the prostate, it is still very possible that a pelvic lymphadenectomy could be carried out relatively easily.
(2) If you were originally treated surgically, you could have a pelvic lymphadenecomy and radiation therapy (potentially along with a defined course of ADT for 18 months to 3 years).
(3) While the chances of a “cure” are probably not high, some very long-term remissions have certainly been achieved in many node-positive patients.
(4) If either the [11C]choline- or the Axumin-enhanced PET scan showed the presence of oligometastatic cancer beyond the lymph nodes to one or even two metastatic sites, it has also proved possible to induce long-term remissions in some of those patients too. Jim Waldenfels is a case in point, and I am sure Jim would want to believe he was cured.
As usual, this would all depend on the unique characteristics of the individual patient.
A lymphadenectomy is much more involved than a robotic prostatectomy.
(1) If most surgeons will refuse to operate for hemorrhoids and similar operations after radiation treatments for prostate cancer, why would they operate on a lymph node away from the prostate bed?
(2) Sure, but that is not the issue.
(3) That’s the answer I am looking for (not for me, just general info), thanks
Dear Wolfram:
I wouldn’t go near “most surgeons” for a radical prostatectomy of any type. In the same way, I wouldn’t go near “most surgeons” for a laparoscopic lymphadenectomy. These are specialized operations that one should have done by people who pretty much do operations like this and not much else.