PSMA PET required for LU PSMA therapy? - Advanced Prostate...

Advanced Prostate Cancer

13,940 members17,068 posts

PSMA PET required for LU PSMA therapy?

Javelin18 profile image

I'm getting a PSMA PET scan at UCLA next week, so I can see if Lu PSMA therapy will be effective. My understanding is that this is a theranostic treatment, the scan confirms PSMA expression, which confirms that the Lu PSMA will have a site to bind to. I thought that the PSMA PET scan was a required step prior to treatment. Posts on the site talk about local doctors, and other countries administering Lu PSMA treatment, seemingly without scans.

There are two tracer drugs available for the PSMA PET scan, Ga 68 PSMA-11 and Pylarify (piflufolastat F 18). Ga 68 PSMA-11 was approved last December only for use at UCLA and UCSF. Pylarify was approved in May for other sites, and should be more widely distributed due to the longer half life of F 18.

Are those of you that are getting Lu PSMA therapy at other locations required to get PSMA PET scans? What I read of the treatments in Germany, they used scintography to measure the update of LU PSMA, not PET SCANS with a radioactive tracer prior to treatment.

37 Replies

A PSMA PET/CT study is the first step to get therapy with Lu 177 PSMA. They do not treat if there are not visible mets (larger than 4 mm) which express PSMA. Ga 68 PSMA or 18 F Pylarify PET/CTs are acceptable tests for evaluating if Lu 177 PSMA therapy can be done.

The good news is that both PET/CTs are covered by Medicare now. This is a recent event. If one has had one or more of the following procedures :prostatectomy, radiation or chemo and PSA is progressing, the test will be covered by Medicare.

I thought PSMA scans were approved by FDA at the two California institutions, and we were all awaiting Medicare approval of them for certain indications.

( and we are awaiting FDA approval of the other type of PSMA scan, which then will be considered by Medicare for coverage in many other locations

If There is more recent info, can you share a link, please?

Ga 68 PSMA and 18 F DCFPyl (PYLARIFY) PET/CTs are covered by Medicare, if the patient has PC, and has an increase in tbe PSA after prostatectomy, radiotherapy or chemotherapy. I talked directly with UCLA and with the company making the Pylarify. Just call UCLA 310-794-1005.

Here is a link to the FDA announcement of the approval of 18 F DCFPyl (PYLARIFY) , fda.gov/drugs/news-events-h....

Page 8 of this document shows the update in medicare billing code for Ga 68 PSMA, cms.gov/files/document/mm12... . I don't understand medicare billing speak, but my understanding of the billing code change is that it makes it now billable.

Thanks for links. Billable vs definitely payable. They will establish coverage guidelines.

“listing of the radiopharmaceutical agent and procedure code do not imply coverage. All of the procedure codes are subject to Medicare rules and regulations, applicable Local Coverage Determinations (LCDs), and medical necessity. The radiopharmaceutical agents may be subject to CCI (Corrective Coding Initiative) editing and hospital outpatient prospective payment system rules. ”

I recently had an Axumin scan, which was equivocal after a continued rise in PSA to 0.72. My MO stated that they (Dana Farber Cancer Institute in Boston) now have /offer a PSMA test. I don’t know which contrast agent they use.

He said he wanted another PSA test in three months before pulling the trigger on a PSMA test, as insurance - according to him - will only cover the cost once, and he wanted it to be used with a better chance of success in locating where the PSA is coming from.

Good luck to us all!

This is the link to the document from Medicare. Search for Ga 68 PSMA PET CT and Pylarify I believe in pages 53 , 57 and 62 of the pdf format of the document (group 10 and Group 16).

cms.gov/medicare-coverage-d...

Most helpful. Right now I am just finding these are now covered by Medicare instead of a bone scan or after an inconclusive bone scan for initial diagnosis. I Will read more. Thank you so much. I assumed we’d see it in the press first.

It took me several days to find this information. The local cancer center started doing the Pylarify PET/CT, mi doctor order one and I called them to make the appointment and inquire about the coverage.

they were not sure if Medicare will cover it since I was going to be patient 1 for this test for them. I asked how much will be if Medicare does not covered it?. They said $ 21,700.00.

I did not want to risk it and I made an appointment with UCLA. UCLA told me that it will be covered by Medicare and I did not have to pay the $ 3,300.00 like in previous occasions. They did not know anything about Pylarify coverage.

Eventually getting in touch with Lantheus the company making Pylarify and using some of the codes for billing they sent me I could find the document from Medicare which is very recently, I believe from this week.,

The good news is that people with Medicare part B will have to pay around $ 1,000 (20% of the $ 5,000 to 6,000) that Medicare will pay for these PSMA tests. People with Medicare Advantage or supplementary insurances for part B, will have to pay nothing, or $ 200 to $300 . Big difference.

Yes, one place that my husband goes for specialty care said it might be $17,000…they were just pricing it.

If Medicare doesn’t cover it for a man’s specific situation, I believe he will be liable for the entire amount. “Any use and all uses of PET scans that are not specifically listed in the NCD are non-covered. Providers are encouraged to review the entire CMS NCD for PET Scans at: Medicare National Coverage Determination Manual, Chapter 1, Part 4 on the CMS Web site for further details and clarification of coverage. Providers are to bill G0235 for non-covered indications. ”

That document you so kindly shared was not a National one but one developed by one of the Medicare contractors for a specific geographic area including California.

Men need to be financially careful right now…like you were…they don’t need financial bad news on top of their cancer.

That is good news about UCLA!

Again, Thanks so much for sharing.

You should perhaps read a few of my post on my profile. I had an PSMA a pet scan and showed activity and was in a trial and after my first dose of LU 177 Almost died because of what it did to my bone marrow. I platelets dropped dramatically my hemoglobin dropped a medically and I’ve been doing platelet transfusion and for blood transfusion since my first injection and of course will be my last injection because my PS I kept going up after doing LU 177. The more important scan I found out afterward is the scan to see how much cancer you have that is not PSMA avid. This is what causes problems with some people like myself. Good luck with everything

John

Javelin18 profile image
Javelin18 in reply to greatjohn

greatjohn,

Thanks for the reply. I'm sorry to hear about your very bad reaction to the treatment. I will look up your posts.

I've been told that I will be removed from the program if I develop anemia. My red blood count hasn't full recovered from the docetaxel, so I am concerned about it. It is at the low end of the normal range. I'm trying to build red blood cells by making sure I get enough dietary sources of protein and iron, while supplementing with B complex vitamins.

My oncologist also said that they had a patient that died after a single Lu PSMA treatment. The thing is, I don't know of another therapy that would be better. I've discussed it with several UCLA doctors and one at City of Hope. The consensus is that Lu PSMA has progressed the furthest of new treatments, so is probably my best option at this point. I've also reached out to MD Anderson to talk to them about other trials. I understand that there is risk to the treatment, but know the outcome from not treating.

How are you doing with your treatments. Have you found a therapy that is providing relief?

Javelin18 profile image
Javelin18 in reply to Javelin18

I have also had a recent Axumin PET scan, which will be compared with the PSMA PET scan. Thanks for you advice on that.

greatjohn profile image
greatjohn in reply to Javelin18

The pet scan that tall Allen mentions below is what I was talking about to make sure they LU 177 will not cause more harm than good.I have been speaking with Dr. Gary Onik Who is actually located in Fort Lauderdale Florida and does some out of the box type treatment using immunotherapy . Not covered by any insurance, but that has worked for some people. All the best to you on the journey. Just let me know if there any other questions you have about him or my past treatment.

greatjohn profile image
greatjohn in reply to Javelin18

I am talking now to doctor Gary Onik Who does out-of-the-box non-standard of care treatments and is located in Fort Lauderdale where I live. If you Google him he’s rather famous. I am talking to him about doing a personalized immunotherapy. He’s quoted me approximately $60,000. The price interrogative this can be pretty much without bad side effects or death rate quicker. I haven’t had by an office visit with him I have only spoken to him on the phone and given him my case history. That is something you might want to think about looking into as well. We don’t have a lot of choices left it seems, prayers my help so I pray every day mostly a prayer of gratitude for the time I’ve had. I also pray I can be around to help with my partner because once I’m gone he’ll have to go into memory care and for a little puppy Sparky who is now only turning eight years old on the same day I found out I had cancer January 14. I worry about him when I’m gone. He’s really been my only Caregiver and friend and confidant from start to finish with my cancer journey.

joeguy profile image
joeguy in reply to greatjohn

Sorry to hear about the negative impact the LU177 treatment had on your bone marrow. Did they give you an idea of how likely bone marrow damage was before you received the treatment? I am considering applying for an LU177 trial that is treating people like myself that are taxane chemo naive. I am Mcrpc with only lymph node Mets ( no bone yet), and have read of great success of LU177 on others like me. I am however slightly terrified of killing my bone marrow with the treatment.

greatjohn profile image
greatjohn in reply to joeguy

I think it would be worth the risk on the one treatment. If there is a lot of bone marrow issue and low hemoglobin and platelets after that treatment, I would be very leery of going further. But I think I learned in a treatment trial you can stop at any time. The doctor running the trial wanted me to try and stay and do another. I’m pretty sure I would’ve been dead by now if I had. So you have to make your own judgment. This is a journey with lots of turns and hills and valleys and scary places, but with also vistas that people who don’t understand this will never see. I have become a much more spiritually aware and thankful person because of the issues I’ve gone through. I loved my life and I still love it with all the hardships I am bearing. As I say “Life is Beautiful Now”gJohn

Olivia007 profile image
Olivia007 in reply to greatjohn

Thanks for letting us know my dad is 83 and doctor wants him to try it my dad is current weak from the Xtandi and other meds he takes I can’t imagine what will happen to him if he tries this

You are always required to get a PSMA PET scan before LuPSMA treatment. IMO you should also get an FDG PET scan (although it is controversial). You can call Pylarify to find the nearest site to you:

1-800-964-0446 (8:30am-8PM EST)

GoBucks profile image
GoBucks in reply to Tall_Allen

What will an FDG PET scan do and why get it?

Tall_Allen profile image
Tall_Allen in reply to GoBucks

It will show how much of the cancer is not PSMA-avid. There is no point in getting PSMA therapy if it only selects for the non-PSMA-avid cancer, which is more virulent.

prostatecancer.news/2019/12...

Javelin18 profile image
Javelin18 in reply to Tall_Allen

Thank you Tall_Allen,

I understood the problem of tumor heterogeneity, but the article helped to frame the information in a good. way.

I have had a recent Axumin PET scan, which sounds very much like FDG PET, since both use a radioactive tracer tied to glucose ( hard to tell from my limited research if FDG and Axumin are the same tracer).

I understand that if PSMA isn't expressed highly, that most of tumors won't have a place for the LU PSMA ligand to attach. This would imply that the treatment would not be effective, and not worth the risk.

However, I'm not convinced that it better to not treat highly PSMA avid cancer, fearing that the remaining non-PSMA expressing cells will repopulate. It seems that any therapy leaves unaffected tumor cells which then repopulate.

The unfortunate truth is that no treatment kills all cancer cells. The alternative to treating the highly PSMA avid tumors would be to do nothing, and have the PSMA avid cells continue to grow. Since more aggressive forms of the cancer expresses PSMA more highly, it seems wise to treat those cells, and use other treatment regimens for the non-PSMA expressing cells. With this in mind, I will be switching from aberaterone, which showed little benefit, to enzalutamide just after my PSMA PET scan. My oncologist and I are both hoping that the enzalutamide will be effective against the non-PSMA expressing cells during the Lu PSMA treatment.

To "cure" the cancer, all heterogeneous forms of the cancer need to be killed, and dormant cells, not yet vascularized, need to be kept from accessing a blood supply. I don't expect to go into remission following the Lu PSMA, but rather expect to have to keep playing wack-a-mole for years to come.

With that in mind, I've reached out to MD Anderson to discuss what trials might benefit me. It may be that there is a trial that would be more effective against all forms of the cancer, but I haven't seen it yet. PT-112 and Veyonda look promising, since they both show an abscopal effect killing cancer remote from the treatment site.

The article you cited said that PSMA is most highly expressed early in metastatic disease. This is another reason to strike while the iron is hot, and treat the PSMA expressing cancer now.

The article didn't provide a reference for the assertion of when PSMA is most highly expressed. I had seen this in another article that provided references for everything but that assertion. When I asked the research doctor at UCLA about it, he said they still did not know the answer of how best to time PSMA ligand based therapies. Do you know of a reference for the paragraph that discusses the timing of PSMA expression?

Tall_Allen profile image
Tall_Allen in reply to Javelin18

Axumin≠FDG. 2 completely different metabolic scans.

Javelin18 profile image
Javelin18 in reply to Tall_Allen

Thanks,

But do they show the same thing?

It looks like both use F 18 tied to glucose, so would both show cancer cells that consume glucose rapidly along with other cells that are consuming glucose rapidly. It seems that either would be useful as a comparison to PSMA PET to judge PSMA avidity.

Tall_Allen profile image
Tall_Allen in reply to Javelin18

No, they do not show the same thing. FDG uses F18 tied to glucose. Fluciclovine uses an amino acid, not glucose, with F18. Glucose is usually only metabolized by PCa later in progression.

Javelin18 profile image
Javelin18 in reply to Tall_Allen

Thanks for clarifying that.

slpdvmmd profile image
slpdvmmd in reply to Javelin18

First let me preface that I am not a radiologist but my understanding is FDG PET is based on FDG being an analog of glucose and uptake is enhance by increased glycolysis in tumor cells. Conversely in brain imaging deficient areas of uptake can have importance regarding brain metabolism which correlate with injury. My read on the role of FDG PET in prostate cancer is that it is at best controversial with reported sensitivity of 1% to 80%. When I tried to sort through this in deciding what direction to go for myself it appeared there was some improvement in sensitivity for detecting/staging in prostate cancer with higher baseline Gleason Scores and higher PSA values. In initial trials in Germany with 177-Lutetium often FDG and PSMA PET/CT were both performed however PSMA PET/CT has now largely supplanted FDG PET (which has a very distinct role in Breast and Colon Cancer) outside the research front. This was substantiated when I was in Heidelberg where I posed this very question. And yes you need a PSMA PET/CT prior to Lutetium. The post dosing scintigraphy is to confirm uptake at the area(s) defined by the PSMA PET/CT.

I was in the vision study. They flew me to Encocyte in Houston, had my scan, put me up in a hotel, and flew me home the next day. Never saw the scan results but was accepted into the study. It would have been good to see the results especially if I had been planning to seek treatment overseas on my own dime. Good Luck!

I’m in Munich having Lu177. I was required to send a PSMA scan in advance. I had Pylarify.

I AM GETTING MY PSMA PET scan END OF OCTOBER IN UCLA, I TRIED TO MAKE APPOINTMENT IN UCSF BUT COST WAS $18K OUT OF MY POCKET, WAS TO EXPENSIVE FOR MY, FINALLY I CONTACT UCLA AND THE TEST COST $3,300 OUT OF POCKET IN CASE INSURANCE DOES NOT KICK IN, I LIVE IN ARIZONA AND MY INSURANCE ONLY COVER INSIDE STATE LINE, TRYING TO APPEAL BECAUSE ONLY OFFER IT IN CALIFORNIA. STILL WAITING BUT I HAVE MY DATE ALREADY FOR APPOINTMENT FOR THE PSMA PET SCAN, IT IS A BIG WAITING TIME TO GET IT DONE, CALL AHEAD IF YOU WANT TO GET ONE, I HOPE AFTER THIS SCAN I WILL BE ABLE TO GET THE PSMA Ga 68 PSMA THERAPY. I WILL KEEP YOU POST AFTER MY TEXT.

Javelin18 profile image
Javelin18 in reply to luis85715

Thanks luis85715,

It was a 6 week wait from the time I made my appointment at UCLA, until my upcoming October 15 scan. Nerve racking to wait that long.

Hopefully your insurance will cover it now that medicare is covering it. The benefits coordinator at UCLA is working with my insurance to try and get coverage.

RCOG2000 profile image
RCOG2000 in reply to luis85715

Psma pet isAvailable in Arizona I had one a month ago at Simon med imaging and the Phoenix Metro area covered 100% by Medicare

BruceSF profile image
BruceSF in reply to RCOG2000

The PSMA PET at Simon Med is the Pylarify scan (F-18 DcfPYL) which was FDA approved in May 2021. It’s just as good as the GA-68 PSMA PET scan (maybe even a little better) and is available at more places than GA-68 (the FDA approved GA-68 PSMA PET only at UCSF and UCLA, but placed no such restriction on Pylarify).

Hey Javelin, It sounds like we are on similar paths re. PSMA scans & doctors. I have doctors at both at UCLA and COH helping to manage my metastatic prostate cancer. I’m scheduled for a pyl scan next Wednesday at the VA in Westwood. I’d like to compare notes with you if you’re open it. LMKThanks, Phil

I have just done with my third LU 177 infusion...You will need to Ga68 PSMA scan before the radiologist and the oncologist will agree to proceed with the LU 177 treatment. Hope this helps.God bless

CAMPSOUPS profile image
CAMPSOUPS in reply to bellyhappy

Any consideration for health of bone marrow prior to treatment other than standard blood tests ?Anything that can be done to better prepare the marrow ?

I got my PSMA scan at UCLA yesterday. With my fatigue I usually fall asleep during scans or radiation treatment, and I did again. Glad that I didn’t jerk awake this time.

I felt tired afterwards and napped for an hour. It could be from the procedure, or relief from the stress of waiting 6 weeks for the scan, or something else. It’s easy to ascribe every symptom to the cancer, but I’ve learned that many times the cause is something simpler.

UCLA had applied to Blue Cross for coverage, but it was still in process. I decided to pay for it rather then getting in the back of the line for a new appointment. I’ll need to deal with Blue Cross directly to get reimbursed. My oncologist is communicating with them, to provide the medical justification for the scan.

You may also like...