PSMA -- Isn't it hard to obtain in th... - Advanced Prostate...

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PSMA -- Isn't it hard to obtain in the US?

LifeQuality profile image
LifeQuality

I just watched Darryl's interview of Dr. Martin from Australia. Am I missing something, or didn't he say that PSMA Pet scans are considered SOC -- implying that they are commonplace or easily available? The FDA approval in the USA was only 5 months ago, right? And there are very few places offering it--in Calif, it's only at UCLA and UCSF, and very hard to obtain. Are we talking about the same thing?

49 Replies

Hi LQ,

Nope. The doc is talking about Australia not the US. PSMA-PET has been available in most countries with socialized medicine for a long time. Not so in the US with its complicated interrelationship between government oversight and private business actually directing the game. We get drugs and procedures when the money says we can have them. The FDA, AMA and the privately owned hospitals aren’t ready for the old equipment to be declared obsolete and their staff forced to retrain. And then, the insurers need to determine how much they’ll reimburse to whom for what. Capitalistic medicine is complicated.

Jeff

Nalakrats profile image
Nalakrats in reply to ragnar2020

So well said--because what you said is true, true, true!

Nal

Hello Nalakrats. I was curious what you meant on the patrick turner post, you said you never seen anybody come back from radium 223, I have my 12th and final carboplatin and cabataxal infusion on the 20th, then the only thing the onc is suggesting is radium 223 is this a last resort? as I have heard multiple times. The doc did indicate we may be able to circle around to chemo again. What would you do, my psa has gone from 243 to 6 on chemo my recent c.t and bone scans show no new progression. Looking for options thankyou.

I do not think it is a last resort, just that I had 3 close friends not on HU, go down this path. The last cycles of Chemo, and then Radium 223, and then cycle back to chemo--they did not finish their last rounds----post 223. One was smart he went home and got in his favorite chair, said no more chemo, and enjoyed some time. So I am a bit jaded to this sequence. I believe, before doing 12 Chemo's I might have done something else. I will meet you on messenger.

For clarity, medicine in Australia is not ‘socialised’ in any meaningful sense - there is no dominant government provider, such as the NHS in the UK. There is, however, a degree of price control over diagnostic services (such as PSMA PET scans) and over drugs - but you’re still free to choose your doctors and negotiate price if you prefer to engage them privately.

And none of that has anything to do with why PSMA PET has been available in Australia since 2016.

The technology was first developed in Germany, and was quickly picked up on by Australian doctors. The main reason this happened more quickly in Australia than many other places is that nuclear medicine is more lightly regulated than most other first world jurisdictions.

Probably not as interesting as the ‘big pharma’ conspiracy theories that are regularly trotted out here - but just happens to be true.

rscic profile image
rscic in reply to ragnar2020

So much for the American excellence myth .... BTW Australian's live, on average, about 4 years longer vs those of us in the USA AND pay significantly less per capita for health care.

My understanding is that the psma pet in California uses Gallium which is very difficult to manage and they need special equipment on site to store it. My dr’s have been talking about PSMA PET/CT with PyL instead of gallium and they are expecting approval by years end. That flavor of psma pet/ct will not be hampered by the shortcomings of gallium and psma imaging will be more readily available. There are several ongoing clinical trials with PSMA PET/CT with PyL technology you may qualify for.

The PYL tracer is more stable and will allow for off-site production of the contrasting agent. This is why it is being pushed definitely because the scanning equipment used is standard CT's. That said, the PYL tracer does not have the same efficacy as the G68, it's close, but just not there. The study being used to promote it's use makes some notes as to the difference between the two, how much more PYL was used and allowed to saturate for a longer period of time in order to match the potential of the G68... Is funny how G68-PSMA-PET scanning is the measure by which all others are compared to lately, and there's a reason why. Personally, I suggest this scan only be obtained at a Major Cancer Center, especially one of Excellence to ensure its application and review are top notch! There going to be some serious learning curves going on at lessor institutions and local facilities trying to cash in.

Just some $.02, take it for what it's worth ;)

prostate.org.au/media/79042...

You probably know the information contained already. But thought I would share for those interested.

TJGuy profile image
TJGuy in reply to Aussiegu

What was the date of this study result?

Aussiegu profile image
Aussiegu in reply to TJGuy

From March 22. 2017 to November 02. 2018.

Many need a PSMA PET scan sooner (now) rather than later for treatment decisions. Mostly to 1) target oligometastatic disease with RT precisely, or to know that is futile. Or 2) to decide if travel to other countries (or enter trials in the US) to access Lu177-PSMA treatment may be worthwhile. For now that requires travel to UCLA or UCSF, or for veterans to the Greater LA Veterans Healthcare Center, where the scan is free for vets.

Cancer2x profile image
Cancer2x in reply to MateoBeach

Here’ s info from the VA Center in LA regarding PSMA recruiting for their clinical trial. More at their website, including numbers to call. Trial is running through 2023, and IS free to any Vet meeting the inclusion criteria, which I am posting below:

A) Participants with biochemical recurrence who are potential candidates for any salvage treatment. Biochemical recurrence is defined by rising PSA after definitive therapy with prostatectomy or radiation therapy, as any of the following:

Post radical prostatectomy (RP): PSA equals to or greater than 0.2 ng/mL measured more than 6 weeks after RP

Post-radiation therapy : Nadir + greater than or equal to 2 ng/mL rise in PSA B) Participants with known prostate cancer who undergo restaging because of new symptoms C) Participants with known metastatic prostate cancer who undergo restaging because of rising PSA with negative or inconclusive conventional imaging D) Participants with known prostate cancer who are treated medically or with RLT in whom response to treatment is assessed

Capability to provide written informed consent

Able to remain still for duration of each imaging procedure (about 30 minutes) * Participants may be reenrolled in the study, if 18F-DCFPyL PET/CT is performed for subsequent management decision.

FYI. Considering going there myself. Getting an Axumin scan next week, but it apparently is pretty inferior to the 68Gallium-PSMA-Pet.

PSMA PET scan available at the LA Veteran's Healthcare Center....really? Do you have more details, MateoBeach??

pete-ginger profile image
pete-ginger in reply to garyi

It’s ONLY FDA-approved for UCLA and UCSF in USA although there are some clinical trials underway elsewhere.

safari1 profile image
safari1 in reply to pete-ginger

clinicaltrials.gov/ct2/show...

Shooter1 profile image
Shooter1 in reply to garyi

Yea, please fill us in.

safari1 profile image
safari1 in reply to Shooter1

clinicaltrials.gov/ct2/show...

ragnar2020 profile image
ragnar2020 in reply to garyi

Dear Garyi,

Here's the information you need to pursue a PSMA-PET for no cost at the LA Veterans administration.

Gholam Reza Berenji, MD, FACNM

Co-Chair, Radiation Safety Committee

VA Greater Los Angeles Healthcare System

Clinical Professor of Radiology

David Geffen School of Medicine at UCLA

310 268 3547

Dr. Berenji will explain to you as he did me that if you're a veteran with PCa, you will need to register with the LA facility to become a patient. They will send you the forms to do this. Once you are registered, they will schedule you for the PSMA-PET scan. There will be no cost to you. The registration will confirm the details of your PCa.

Further, you need a referral from one of your attending physicians. Dr. Berenji told me that it could be your PCP, your urologist, RO, MO or any referring physician. You'll need to bring the signed form with you when you arrive for the scan.

There is a facility in LA called Fisher House that provides short term lodging for veterans getting care at the LA VA facility who have traveled to LA from more than fifty miles. Look up Fisher House on the internet and register with them for lodging during your stay when you schedule the scan.

Using the VA, your costs for the scan can be reduced to what it costs you to get to LA and return home.

The interesting point as far as I was concerned was a comment from Dr. Berenji. When I told him that my PSA was presently undetectable and that I'd read that the PSMA-PET wouldn't detect any micro-mets in men with a PSA of less than .4 to .8, he told me that wasn't true. He said that they have had patients with undetectable PSA who have had micro-mets revealed by the PSMA-PET scan.

I found this to be exceedingly interesting. For men with undetectable or low PSA scores but who have been diagnosed with high GS (mine is GS 9/10) we're told to wait until our undetectable PSA rises to above .4-.8 or we have a PSA doubling time (PSADT) of less than six months. But, if we rely on PSA alone to detect the presence of micro-mets within our bodies, we risk the chance that mets can be growing and getting a headstart on what will become our eventual systemic treatment plan.

I hope this information helps you with your treatment planning.

Jeff

flyguy profile image
flyguy in reply to ragnar2020

What is the Fisher House? Is it near the facility, is it free or discounted for Vets?

ragnar2020 profile image
ragnar2020 in reply to flyguy

Here’s the URL

losangeles.va.gov/fisherhouse/

flyguy profile image
flyguy in reply to ragnar2020

Thank you very much.

They should be SOC! My husband was denied last November by private insurance Anthem Blue Cross, and not only because it wasn't approved yet, they wouldn't even approve a standard PET scan "not medically necessary " So CT scan & bone scan, both clear! Now he's on Medicare and it was approved! He had it yesterday at UCSF and found one bone spot and a couple of suspicious extrapelvic lymphnodes ... so what good are those other scans? So frustrating, he should have had it in the first place!

The Mayo Clinic in Rochester, MN has started a study and is using Gallium PET/CT. The requirements are not very stringent. I checked with Medicare and they said they'd cover the PET/CT if the doctor said it was medically necessary. MAYO estimated the Gallium tracer would cost about $880. Instead of using a "gallium generator" they use their own cyclotron to create the gallium--much cheaper. I haven't seen the bill yet but it could be as low as $800 if medicare pays for the PET/CT.

Caution on the gallium. Be careful what you wish for...it's very sensitive for most men. I had a clean conventional CT but I lit up like a Christmas tree on the gallium scan.

--

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Bigdo58 profile image
Bigdo58 in reply to Gudgelm

I blew .61 in Oz but absolutely nothing lit up and that's GA 68! There u go!

When the attachment above says 'expensive' in Australia, I just had one and it is AUD $695.

Soo, what..$450-$500 US. Not terrible in my mind, for the peace of mind!

Available at a number of hospitals but also private imaging centres, not all, but specialised ones delivering the GA 68 version.

binati profile image
binati in reply to Bigdo58

In India it costs around USD 300 and has been available for 4 years.

Actually in Australia, if you were admitted as an in-patient to a hospital, public or privately run, and you had a PSMA-PET scan, it would be 100% covered, if public, by Medicare (Federal purse..taxpayers all levied for that on wages at 1.5% or more) or privately paid healthcare fund..costs AUD 5k + per year for a family, by the service user.

Blackpatch profile image
Blackpatch in reply to Bigdo58

Yep - but diagnostic services aren’t where the really big wins are in the Australian “socialist” system - it’s drugs.

Zytiga is Australia is A$ 40/month for any man when it is being prescribed in accordance with theSoC - which is the vast majority of men who are using it.

I used zytiga off-label during eSRT and even then, the free-market price was A$3.600 pm, or about US$2,800.

There is no govt subsidisation for off-label prescriptions in Australia, so this was the free market price. Prior to generic versions becoming available in the US, I’d heard of people being billed US$10,000 pm for zytiga. US drug pricing is insane - if a small country can negotiate zytiga down to US$2,800 pm, imagine what the US govt could achieve!!

Bigdo58 profile image
Bigdo58 in reply to Blackpatch

Ok...well I've done ADT, Zovigo..and that was free. Not gone deep down other chemo yet..but had advanced met pca for nearly a decade! Robotic prostatectomy then 5 years later 70gy rads, that is all. Only just BCR again.

Looks like some further costs await downstream!

Bigdo58 profile image
Bigdo58 in reply to Blackpatch

I actually still don't get you here... $40pm Soc ('Standard of Care' maybe?)? Or $2800 a month? Off label ..soo not prescribed by a GP or Specialist and bought online at prevailing rates? What are you saying?

Blackpatch profile image
Blackpatch in reply to Bigdo58

Sorry for the jargon. Zytiga costs A$39.90 pm on the Australian Pharmaceutical Benefits Scheme - so this is what you pay if you are prescribed zytiga by an oncologist to treat PCa under the prevailing Standard of Care.

I was using zytiga to turbo-charge ADT accompanying early salvage radiation - it was still prescribed by an oncologist, but it was being used “off label”, which means it was being used in a way that has not been approved as a recognised therapy. The PBS doesn’t control pricing of off label prescriptions, but they/ the government do exert some control over drug company pricing in Australia - I compared prices at half a dozen pharmacies ( representing all the major drug wholesalers) and the zytiga price varied by less than A$300 between them.

Australia’s medical system isn’t perfect, but it’s pretty damn good!!

Bigdo58 profile image
Bigdo58 in reply to Blackpatch

Okay, yes got you! But yeah we are not getting cheap drugs in general if deep in trouble in OZ, but pretty reasonable still by international standards if you can't get them on the PBS! The Feds are moving still on a number of expensive drugs continually...hoping for PARP's subsidised in the end or by Peter Mac trial say as I am BRCA 2.

Bigdo58 profile image
Bigdo58 in reply to Blackpatch

Shoulda asked Blackpatch, how did you go with the early salv + adt + zytiga..did the zytiga help do you think? How early was your salv?

Blackpatch profile image
Blackpatch in reply to Bigdo58

I’m still undetectable, two years post eSRT but who knows if zytiga made a difference? My PSMA PET scan showed nothing prior to eSRT, and a 2020 Australian study has since shown that ca. 82% of recurrent men with nothing visible on PSMA remain recurrence free at 36 months post- radiation with only six months of conventional ADT.

I did the zytiga because I have a very high Decipher score (0.91) and young kids to consider - but there’s no way of knowing if it made a difference. My pre-SRT PSA was 0.12.

Bigdo58 profile image
Bigdo58 in reply to Blackpatch

Okay, thanks for this, interesting, I am 4yrs now since EBRT with 6 months only ADT, nothing since..and at .61 now, but still nothing visible on PSMA. So, sort of marking time until maybe 1.2 and mets light up!

Could just be letting 'the genie' rip, not sure, but rolling the dice!

Bigdo58 profile image
Bigdo58 in reply to Blackpatch

I blew through 2nd BCR at about 36 months from EBRT, mid last year (was 5 yrs post Davinci RP at Epworth Melb, at EBRT point in 2017, so dx at Feb 2012) ..and been basically doubling then going slower for a bit or 'plateauing' as Onc calls it, since. Was surprised at .61 there was nothing 'lit'! Soo, all good from that angle.

Blackpatch profile image
Blackpatch in reply to Bigdo58

When you say you blew through second BCR, do you mean that’s when you went though 0.2? Were tou undetectable post-RRP, or post EBRT?

Not sure how I feel about waiting for something to show on PSMA... but I guess I’ll find out one of these days. I guess no one’s in a rush to start life long ADT. What’s your doubling time now?

Bigdo58 profile image
Bigdo58 in reply to Blackpatch

Never undetectable. Initially .12, 6 weeks after Davinci RP (so RP in May 2012), went down as low as .01 though (apoptosis..mother ship gone seems to be the reason they thought) and sat there for nearly two years. Gradually started climbing then and yes went through .2 Feb 2017... then EBRT + ADT for 6 mnths. ADT alone dropped me from .27 to .05, then EBRT took it down again to yes, you guessed it.. .01. Never zero. It has stayed below .2 since then including a 12-18 month period post EBRT of 'remission' as the Onc said he 'had to' label it. Went through .2 again May last year then .37 last November. I was getting back pain suddenly last month and pulled the trigger with the Onc on PSMA, also had standard X ray same time, nothing lit. Skeletal only..BUT still reading higher.. .61 now. So on 3 mnth checks now. So getting worried that climbing ever so higher and not locating mets! If I hit 1.2 likely within next 12 months and we go again and see nothing lit up, I am in trouble.

Sorry. What is a decipher score

Decipher is a genomic test you can have done on prostate biopsy or, post -RP, on prostate pathology specimens. Testing of biopsy specimens predicts pre-operatively the severity of the cancer present; post-op testing of pathology specimens gives a more detailed picture, including chances of eventual metastatic disease and PCa-related death. decipherbio.com/

I went into the RP expecting T2 and woke up to T3b, which worried me enough go have the test done.

Would be $40 a month if it was approved for the PrescribedBenefitsSchedule by the Feds!

But otherwise noo, and lots aren't approved unless you have PC political 'sway' like breast cancer does and its associated drugs! Not that is bad for our 'sisters' but it is what is happening in OZ at present.

My first G68-PSMA-PET scan in 2018 was provided by participating in a trial. My last one in 2020 was covered by my insurance and not at one of those approved institutions!

When your team knows, champions and fights for your medical necessity, insurance sometimes follows along! Just sayin... ;). So don't automatically assume you need to go to the approved FDA locations (2).

And quite frankly, I cannot understand how exactly that can happen as it lends to some serious thoughts on (FDA) impropriety!!! Like JH doesn't know how to do it right? Or MSK?... Yeah, oh, ok!

Our personal sense of urgency meets bureaucratic red tape. I wonder sometimes if it is solely money driven, or it is the group think of inefficiency performed in the name of public safety. Whatever the case, ultimately it becomes another prick of a thousand knifes as we continue our monthly waits for Godot.

Four years ago I went down to Melbourne, AU to have a Ga-68 PSMA PET/CT scan performed since it wasn't approved yet (however available at UCSF) in America. It was $2750 in CA and $600 in AU and no insurance would cover it. In retrospect I wouldn't have had the scan and the subsequent lymph node surgery if I knew then what I know now. The surgery decreased my PSA to about 50% for less than a year, but then started climbing again. I started applying tE2 gel three years ago as suggested by Richard Wassersug and my PSA has been staying well below 0.014 for the last two years with some gynecomastia as my only SE. It is currently 0.003.

I had my 1st 68Ga-PSMA-11 PET/CT scan 08/01/2019 at IU Neuroscience Research Center under IU School of Medicine Clinical study trial. That’s in downtown Indianapolis, USA. Successful Yes! It or the Gallium found my Met’s in Pelvis, lower abdomen. Lymph nodes and also lesser in my upper abdominal aortic lymph node areas.

That was 2019. How did i qualify? One of my 2 IU Health urologist recommended me due to my Biochemical PSA pCa recurrence 2nd time. I believe that trial is still active, was suprised that my super uro/oncologist put me in immediately. I even talked a bit to the Radiopharmocist scientist that actually “mixed the Gallium radio-isotope” before injection. Getting up close and personal with a nuclear medicine front line scientist, it doesn’t get any better than that.

Yes i’ve asked for a repeat 68Ga-PSMA-11 re-test in 2020, but my PSA is still too low(0.485) to qualify. PSA has to be > 3.0ng/ml to be PSMA PET detectable.

I’d love to due a repeat PSMA scan soon, but lets make that Scan readily available now. Good luck.

Doug

Blackpatch profile image
Blackpatch in reply to depotdoug

I guess every institution will have its own rules for making scans available, but to be clear, PSMA PET can detect PCa in as many as 65% of BCR men even when their PSA is only 0.5.

With the scans widely available, they are commonly run at these low PSAs in Australia because there is prognostic value in a negative result i.e. if the PSA is low and the scan shows nothing, then the scan result gives much greater assurance that recurrence is unlikely for the next 2 - 3 years. This approach is being used at Peter Mac in Melbourne and in Major PCa treatment centres in Sydney and Brisbane.

Greetings Y'all,

I enjoy reading posts such as this one. The respondents have knowledge and experience, and those are two very important factors when it comes to dealing with medical issues. Thanks for taking the time to read and then post your opinions and experiences. Everything expands the knowledge base.

Jeff

WOW--The many responses to my question have been very helpful and informative. This is, once again, a great forum! I have one followup question: Is the actual PET scan experience like an MRI, in terms of requiring the ability to withstand a potentially claustrophobic condition inside a tube? Or is it more like a conventional CT scan or bone scan that is in a relatively "open" machine?

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