Generally speaking, PSMA PET Scans are performed on patients for initial staging (after recent diagnosis) or for restaging (after therapy if recurrence is clinically suspected). For patients recently diagnosed with prostate cancer, PSMA PET Scans are typically used for those patients deemed to be intermediate or high risk. Your doctor will make that determination based upon many factors. Similarly, those patients who have had prostate cancer and been treated sometimes show clinical signs of recurrence. Those patients also were or are in intermediate to high-risk categories and if your doctor feels you have a recurrence, a PSMA PET Scan is often requested in order to identify sites of recurrence.
PET Imaging Institute of South Florida is currently one of the few commercial providers of PSMA PET Scans and has performed more commercial PSMA PET scans than any other facility in the United States. If you would like to visit us for your PSMA PET scan, click here to provide your information. A valid prescription from your treating healthcare provider is necessary in order to perform your PSMA PET Scan. You may send it to our PSMA Fax Hotline at: (954) 607-6757 or email it to: firstname.lastname@example.org. We look forward to hearing from you!
Of all available conventional and advanced imaging studies available today, PSMA PET Scans with Pylarify (18F-DCFPyL) have been found to identify more prostate cancer lesions than any other imaging study. If you or someone you love has prostate cancer, you may have had CT scans, bone scans, MRI scans, or other PET studies such as FDG PET Scans. While each of these studies has its pros and cons, only PSMA PET Scans have the overall power to sensitively detect prostate cancer -and- specifically, characterize these findings as prostate cancer. Some tests, such as bone scans, are very sensitive and can detect many findings in the skeleton. However, bone scans are not specific, and many non-cancerous sources of uptake such as arthritis or prior injury can “light up” on a bone scan. While MRI is excellent at evaluating the prostate gland itself, it does not evaluate the whole body like PSMA PET scans do. PSMA PET Scans can not only detect many prostate cancer lesions, but when positive, it has a very high likelihood of representing prostate cancer as well.
Yes. PSMA PET scans using 18F-DCFPyL were approved on May 27, 2021. Commercial production is underway and several PET scan facilities such as PET Imaging Institute of South Florida have been performing PSMA PET Scans for several weeks now.
While challenging to outline all the differences between the two studies, here are some of the points related to patient-focused questions we have recently encountered on this subject. PSMA PET scans are FDA approved for -both- initial staging of prostate cancer for men recently diagnosed with certain types of (higher risk) prostate cancers as well as for restaging of men with suspected recurrent prostate cancer.
Axumin is only FDA-approved for restaging of prostate cancer. Axumin has been FDA approved since 2016, and therefore has insurance billing codes available and is usually covered by insurance (if properly indicated), whereas Pylarify does not yet have billable codes from insurance companies and is often self-pay at this point.
The statistical performance of PSMA PET scans seem to indicate that it performs better in most important aspects of diagnoses such as sensitivity (ability to detect findings) and specificity (once detected, the likelihood those findings are truly related to underlying prostate cancer).
Regarding availability, once again Axumin has an advantage as it has been FDA approved for many years now. PSMA PET Scans, only recently FDA approved, have to go through a ‘ramp up process’ where more and more places will make PSMA, and then more PET scan facilities will be able to perform these scans worldwide.
PSA level alone is not necessarily the sole data point for deciding whether or not to get a PSMA PET Scan. Many factors are involved in determining your risk of metastatic disease (if PSMA being performed for initial staging) or prostate cancer recurrence (if PSMA being performed for restaging). Many other factors will be evaluated by your ordering physician and will likely include your Gleason Score, other findings at the time of biopsy and/or prostatectomy, history of previous therapy, rate of rise of your PSA, doubling times, etc.
Your treating physician will make a determination as to whether or not PSMA PET Scanning is indicated. One of those factors is the PSA level. Generally speaking, PSMA PET Scans using Pylarify (18F-DCFPyL) have been shown to be effective at PSA levels above 0.2ng/mL. Also generally speaking, the higher the PSA level (when restaging patients), the more likely a PSMA PET Scan is to detect and identify recurrent prostate cancer.
Again, these are general guidelines, and it’s important to remember that a “negative” PSMA PET Scan does not necessarily 100% exclude the presence of prostate cancer. However, of all available conventional and advanced imaging techniques available today, PSMA PET Scans show the most promise in being able to identify metastatic disease and/or prostate cancer recurrence and guide further management.
Any valid order/prescription for a PSMA PET Scan is acceptable to proceed. This includes licensed physicians as well as any licensed healthcare practitioner legally permitted to write orders for diagnostic imaging studies in the United States or internationally. Valid orders/scripts may be faxed to our PSMA Fax Hotline at (954) 607-6757 or emailed to email@example.com.
Yes, any international patient with a valid order/prescription can have their PSMA PET Scan at PET Imaging Institute of South Florida. Valid orders/scripts may be faxed to our PSMA Fax Hotline at (954) 607-6757 or emailed to firstname.lastname@example.org.
Soon after your arrival at our office and following a brief patient interview to gather history, an intravenous line is started and the PSMA “Pylarify” agent is injected into your vein. After allowing approximately 60 minutes for the PSMA to distribute throughout your body, you will then be asked to use the restroom to empty your bladder. You will then be brought into the scan room for your PET scan. Following your scan, you will receive a disc containing your original full data set from your scan. You are then free to go about the rest of your day. The total process in and out of the office typically lasts about 1.5 hours.
Here is a short video our company made to go over this process in more detail: CLICK HERE.
PSMA PET scans have -not- been shown to be of significant value in first establishing the diagnosis of prostate cancer. Traditional diagnosis via clinical evaluation, imaging studies, serum markers such as PSA, and biopsy is still the proven method of establishing the diagnosis of prostate cancer. Once the diagnosis is established, your doctor will use several factors (in addition to the above) to establish a risk profile. Depending on that risk profile, PSMA PET scans may then be of value in initial staging. Following treatment, PSMA PET scans can also be of value in detecting and localizing prostate cancer recurrence.
Total scan time will vary greatly based upon the type of PET scanner at your chosen facility. At PET Imaging Institute of South Florida, we frequently upgrade our equipment to latest state-of-the-art technology. Our typical scan times for most PSMA PET Scan patients have been 10-12 minutes (depending on patient height). We ask patients to expect to spend about 1.5 hours total in our center from arrival to departure.
Here is a short video our company made to go over this process in more detail: CLICK HERE.
Yes, PSMA PET Scans with Pylarify can be used to qualify patients for 177 Lu-PSMA radioligand therapy. However, the criteria for qualifying for 177 Lu-PSMA radioligand therapy are many, and may differ depending on the institution offering that therapy, or the clinical trial qualifiers for such therapeutic options. A PSMA PET scan is not a single indicator or qualifier for such therapeutic options. However, for those that do otherwise qualify, a positive diagnostic PSMA PET Scan is typically required in order to demonstrate that the patient’s recurrent prostate cancer is “PSMA Avid”. Once a positive PSMA PET scan is obtained and demonstrates the extent of disease, this serves as an additional criterion necessary prior to 177 Lu-PSMA radioligand therapy.
Many of you have questions regarding insurance coverage. To date, insurance companies have not yet established reimbursement for Pylarify PSMA PET Scans. Some patients have reported that their insurance company will “authorize” the PSMA PET Scan. However, authorization is not a guarantee of payment. Therefore, at this time and until those billing codes and reimbursement schedules are established, PET Imaging Institute of South Florida is offering PSMA PET Scans only on a self-pay basis. Patients may choose to pursue reimbursement from their insurance companies as they see fit, but any necessary pre-authorization would be the responsibility of the patient or their physician to obtain.
Not all “PSMA PET Scans” are the same. There two main ‘variants’ of PSMA PET Scans currently in use in the United States. UCLA and UCSF use a specific agent called 68Ga-PSMA-11.
This is a specific agent that uses a “Gallium-based” type of radioactivity and is manufactured on-site at those locations, and -only- for those locations. Based upon feedback from our patients, there is often a long waitlist and extensive travel involved in order to obtain your scan there, as a result of limited availability.
Pylarify PSMA PET Scans were only recently FDA approved but have been made available in locations around the country, offering much greater availability and access to the many patients in need of this test. Also, Pylarify, Piflufolastat F-18, is Fluorine-based and can be produced almost anywhere in the country, markedly improving access to this exciting new PSMA PET Scan for Prostate Cancer.
Axumin was FDA approved in 2016, many years have passed and insurance companies have established specific billing codes for these exams. Even with those codes, many patients have reported to us that their insurance companies sometimes do not cover them. Coverage is specific to your individual history, needs, coverage and plans. However, we fully expect that PSMA PET Scans with Pylarify will eventually (hopefully soon!) “catch up” to Axumin in this regard. Just as soon as we receive those billable codes, all members of our PSMA Priority List will be immediately notified.
In December 2020, the FDA gave special FDA approval to perform a specific kind of PSMA scan only at two specific locations . At UCLA and UCSF, the radioactive component is different (Gallium-68 vs. Fluorine-18) and in addition the ‘pharmaceutical’ component is also a different ‘agent’. Since approved in December 2020, UCLA and UCSF had a 6 month ‘head start’ in working with insurance companies to provide coverage. We are hopeful that the F-18 PSMA Agent, Pylarify, will quickly be covered by your insurance companies. Not all PSMA PET Scans use the same “radiopharmaceutical” (the material injected into the vein for the study). Therefore, protocols and availability vary. As the new PSMA Agent, Pylarify ramps up production, it should be much more widely available throughout the country, rather than available only at two universities on the West coast with rather long wait lists.