PSMA PET scans using 18F-DCFPyL were approved by the FDA on May 27, 2021. Commercial production commenced shortly thereafter and several PET scan facilities such as PET Imaging Institute of South Florida have been performing PSMA PET scans ever since.
PSMA PET Scan FAQ
Who should consider PSMA PET Scan?
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.
Where can I get a PSMA PET Scan?
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: email@example.com. We look forward to hearing from you!
How good is a PSMA PET Scan with Pylarify at finding Prostate Cancer?
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.
Has PSMA been approved by the FDA?
What does “PSMA” stand for?
PSMA means “prostate-specific membrane antigen” and refers to a transmembrane protein that is expressed in all prostatic tissues, including prostate cancer tissues (prostate carcinoma). PSMA may rarely also be expressed in other cancers as well. PSMA PET scans have therefore been shown to be highly accurate in detecting prostate cancer recurrence and in detecting metastatic disease in newly diagnosed men with high-risk disease.
How do I prepare for a PSMA PET Scan?
Unlike other types of PET scans, there are no special preparation instructions for PSMA PET Scans. There is no need to fast, no need to avoid any specific food types, and no special need to drink ‘extra’ water to prepare for your scan. There is also no need to delay or refrain from taking your medications (take all your medications as per your normal routine). If you are diabetic, there are no special precautions needed. Take your diabetic medications and maintain your normal dietary patterns as per your doctor’s instructions.
Do I need to fast for my PSMA PET Scan?
No. There is no need to fast for your PSMA PET Scan. Please see our question above for a full description about PSMA PET Scan preparation. Greater than 99% of all 'regular' PET scans are performed using something called "FDG" which looks to the body much like regular sugar. Therefore, fasting and other special preparation instruction must be followed for that type of PET Scan, but not for PSMA Pet Scans. Pylarify, the PSMA agent used for your PSMA PET Scan, does not require any fasting or special preparation instructions.
Do medications interfere with a PSMA PET Scan?
No. You should continue your normal medication routine and instructions as per your treating physician. Antibiotics also do not interfere with PSMA PET Scans. Of course, if you have any acute respiratory illness, either COVID or non-COVID related, please contact our office and we can reschedule your PSMA PET Scan after you have recovered.
PSMA vs. Axumin: How is PSMA PET imaging different from current prostate cancer imaging?
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 has been FDA approved since 2016 but for only for restaging of prostate cancer. 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.
At what PSA level should I get a PSMA PET Scan?
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.
Does the order/prescription for a PSMA PET Scan need to be from a Florida licensed physician?
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 firstname.lastname@example.org.
Can international patients have a PSMA PET Scan at your facility?
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 email@example.com.
What happens during a PSMA PET Scan?
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.
Can a PSMA PET Scan be used establish the diagnosis of prostate cancer?
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.
How long does a PSMA PET Scan take?
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.
Does the Pylarify PSMA PET scan that you perform qualify me for 177 Lu-PSMA radioligand therapy (RLT)?
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.
Is my PSMA PET Scan covered by insurance?
As of January 1, 2022, CMS provided PSMA PET Scan (Pylarify) with a dedicated billing code, which in turn facilitated Medicare creating a consistent reimbursement schedule, making PSMA PET Scan reimbursable. Other major third-party insurance companies, who tend to follow Medicare, have also added Pylarify to their formulary. However, determination of insurance coverage is specific to your individual history, needs, coverage, and insurance plan. Contact us at our PSMA Fax Hotline: (954) 607-6757 or email to: firstname.lastname@example.org for further details.
What’s the difference between a PSMA scan at UCLA/UCSF vs PET Imaging Institute of South Florida?
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 have been made available in locations around the country. Eventually, there will be much greater availability and access to the many patients in need of this test. In order to produce the Pylarify agent, a facility needs to be approved by the FDA, but as of March 2022, there is a significant delay in the FDA’s ability (and has been for some time) to visit, review, and approve these facilities. The good news is that once the FDA approves a facility, it is Fluorine-based and can be produced easily, which will markedly improve access to this exciting new PSMA PET Scan for Prostate Cancer.
Why might Axumin be covered by my insurance company but PSMA PET Scans (Pylarify) are not?
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, and insurance plan. As of January 1, 2022, CMS and Medicare provided PSMA PET Scan (Pylarify) with dedicated billing code, which in turn facilitated Medicare creating a consistent reimbursement schedule, making PSMA PET Scan reimbursable. Other major third-party insurance companies, who tend to follow Medicare, have also added Pylarify to their formulary. Over time, we believe PSMA PET Scans (Pylarify) will catch-up to (and perhaps surpass) Axumin insurance acceptance.