We had previously reported on a presentation by Calais et al. earlier this year. That study had suggested that 68Ga PSMA PET/CT scanning may be a better option than 18F-fluciclovine PET/CT scanning for men who appear to have disease recurrence and progression after first-line therapy for their prostate cancer.
The original presentation by Calais et al. has now been published as a paper in Lancet Oncology along with an editorial by Fossati et al. Unfortunately, only the abstract of the paper and the first paragraph of the editorial are available on line to non-subscribers to Lancet Oncology. However, there is a detailed report on the paper and the associated editorial on the MedPage Today web site for those who are interested in more information. This detailed report is available at no cost.
We would repeat the fact that while 18F-fluciclovine (Axumin) has been approved here in the USA for use as an imaging agent in men with recurrent prostate cancer, it is going to be some time before we see 68Ga PSMA approved here for such a use. It is also a fact that many payers here in the USA are not going to be willing to cover the costs of this type of imaging test for men with early-stage recurrence of localized prostate cancer (unless the patient and his doctor are determined to fight for such coverage). Medicare, however, will cover at least some of the costs associated with Axumin-enhanced PET/CT scans.
Filed under: Living with Prostate Cancer, Management | Tagged: Axumin, fluciclovine, fluorine-18, gallium-68, imaging, PET/CT, PSMA, scan |
THE "NEW" PROSTATE CANCER INFOLINK 
From my experience, for an Axumin scan, Medicare pays its normal 80% and a Medigap plan covers the other 20% like all Part B costs.
Just an FYI. I had the Axumin scan a few weeks ago in Florida. No fight with my private insurer for coverage. The provider billed my insurer $34,000.00 for the scan. The insurer cut that cost to $11,000.00, of which I have to pay $1,100.00, only a few hundred more than a previous Na18F PET/CT in 2018. A real bargain and I will definitely go back for more!
:-)
Best regards,
Richard
Richard, for comparison …
If you were a fly-in, fly-out visitor to Australia (i.e., not covered by any local insurance or our universal healthcare) your unsubsidised out of pocket cost for a Ga-68 PSMA PET scan would be around US$1,200, which makes $34,000 look like the pick a number, rubbish list cost it is. As a taxpayer, my only outlay is the Ga-68 infusion at around USS400. About to have my fourth scan in 30 months, as these scans are both accurate at PSA > 0.2 and guide my treatment choices.
A couple of additional points: The two scans performed equally well at detecting recurrence in the prostate bed (14% for PSMA vs 18% for Axumin — not statistically different), but the PSMA PET scan was able to detect more cancerous pelvic lymph nodes (38% vs 8%) and non-regional metastases (16% vs 0%). The surprising result is that more recurrences are attributable to pelvic lymph nodes (stage N1) or to extra-pelvic metastases (stage M) than to cancer in the prostate bed. If this is true of all recurrent men, it indicates that salvage whole pelvic radiation is usually preferred over salvage prostate bed radiation. We saw (see this link) that salvage whole pelvic radiation improved progression-free survival compared to salvage prostate bed-only radiation. But in that SPPORT trial, the authors noted that the improvement did not hold up at low PSAs.
Even the best PSMA PET/MRI has a tumor size detection limit of about 4 mm. If cancer in the pelvic lymph nodes is still curable, it may be necessary to treat cancer while it is still undetectable.
Dr Czernin told me that they will be submitting a new drug application to the FDA within the next few days, and if all goes well, FDA approval can be expected in about 9 months. The CONDOR trial of DCFPyL has completed recruitment and has a primary completion date of January 2020, so we may have both PSMA-based PET scans approved within a year.
Sitemaster:
Doesn’t that infer that SRT should always be to both prostate bed and whole pelvic lymph nodes as a precaution? And when should it be done: as soon as PSA starts to increase at all, when it exceeds 0.2, or when it’s high enough for the new CT/PET tracers to visualize?
Allen (or Sitemaster),
Could you please elaborate or comment on the Axumin scan’s ability to detect “non-regional metastasis”, with respect to the 0% detection statistic you cited. Is this 0% detection rate for non-regional lymph nodes, bone, and other sites of metastasis, or only non-regional lymph nodes? Does/can the Axumun scan detect regional bone metastasis and/or non-regional bone metastasis (at any PSA level)? Thank you.
Richard
Dear Bob:
In a general way, it is impossible to answer that question, because so much depends on the goals and desires of the individual patient and how his doctors believe he would respond to such therapy.
The larger the area that is radiated, the greater the risk for side effects and complications of SRT. So while some men may wish to go all out to eliminate the cancer and accept the risk for complications and side effects, other patients may have a very different perspective. On top of that, there is the question of exactly what each, individual patient’s risk/benefit profile might be.
The bottom line is that these decisions all have to be individualized after discussion with the patient and appropriately shared decision-making processes.
Richard:
Non-regional metastases include lymph nodes outside of the pelvis (Stage M1a), bone metastases (Stage M1b), and visceral metastases (Stage M1c). Yes, Axumin can and does detect bone metastases at higher PSAs. In other studies, both PSMA scans and Axumin detected metastases in almost all men whose PSA was ≥ 2 ng/ml. This study was specifically looking at men who were biochemically recurrent after prostatectomy while PSA was still low — most of them had PSA levels of 0.2 to 0.5 ng/ml.
Allen,
Thanks so much for your response about the Axumin scan’s ability to detect bone metastasis. It helped me conclude that the “impressions” from several previous NaF PET/CTs I had stating there is bone metastasis are probably not correct (more likely the scans detected degenerative disease given the relatively low max suv). No bone metastasis was detected by the Axumin scan when my PSA was 37.8.
Best regards,
Richard