PSMA Scan to be approved in USA by FD... - Advanced Prostate...

Advanced Prostate Cancer

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PSMA Scan to be approved in USA by FDA at end of 2020?

dagreer
dagreer

Hi all,

My oncologist down at Sloan mentioned he thought that the PSMA Scan to be approved by FDA at end of 2020. Has anybody heard any rumors as well?

55 Replies
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Rumors for over a year---we will not know, unless we can get some real inside info. IMO, being driven by Insurance Industry/Medicare---that is why something so important is being delayed. Follow the money! [This does not need the same process of Double blind 3 phase trial proofs--used for drugs]Nalakrats

LearnAll
LearnAll in reply to Nalakrats

Agree..Nalakrats. The delay is deliberate by status quo folks ! PSAMA scan is a game changer because it gives a lot of power in the hands of patient as he can see clearly where and how many cancer cells are there. It has potential to knock down lot of unnecessary, toxic treatments being imposed on patients by scaring them to death. Truly, consumer empowering technology !

lewicki
lewicki in reply to LearnAll

Criminal !

6357axbz
6357axbz in reply to Nalakrats

The lead doc at UCLA (Dr. Czernin) told me in June when I was there for a scan that the FDA review of their data was complete and the FDA was totally satisfied with that. The second part of approval they were waiting on was for the FDA to come onsite to approve UCLA’s process for producing GA68. That, he said, was delayed due to Covid.

It sounds like approval, when it comes, will be granted on a facility by facility basis.

Unless your oncologist knows the people on the relevant panel at the FDA, he is just guessing. They were supposed to have reviewed it by now, but shit happens.

dagreer
dagreer in reply to Tall_Allen

He is the chair of the Genitourinary Committee of the National Cancer Institute’s cooperative group Alliance for Clinical Trials in Oncology. Not sure if that means more inside info or less.

Tall_Allen
Tall_Allen in reply to dagreer

Not really. FDA has to keep this all secret. It affects stock prices.

Schwah
Schwah in reply to Tall_Allen

I spoke to Dr. Czernin at UCLA. I believe he runs the program there. I have done 3 PSMA tests there and was told that I can do no more until FDA approval Even if I pay. Dr. Czernin specifically told me not to worry because FDA approval would occur before year end or very shortly there after. We shall see if he was correct.

Schwah

Tall_Allen
Tall_Allen in reply to Schwah

It has been 12 months since approval was asked for, and 9 months is the shortest - so unless they need more data, it should be soon.

Schwah
Schwah in reply to Tall_Allen

TA, based upon your many contacts in the PC world, what is the consensus on the efficacy of this new imaging? Is it pretty well established to be far superior to the current SOC?

Schwah

Tall_Allen
Tall_Allen in reply to Schwah

Yes - it detects more metastases at lower PSA. prostatecancer.news/2016/12...

lewicki
lewicki in reply to Schwah

I tried To pay $5000 asking price at the University of Michigan but was refused because I still Have a prostate. Criminal!!

dhccpa
dhccpa in reply to Tall_Allen

I have heard of it but that's all. Is it really that much better than, say, a PET scan?

Tall_Allen
Tall_Allen in reply to dhccpa

It is a PET scan

dhccpa
dhccpa in reply to Tall_Allen

Thanks! I believe I brought it up six months ago to my RO and he said not available for a while.

Seems to me that of the holdup is on site approval of Ga58 generator and handling, then DCFPyL scans using F18 would simplify that since most nuclear imaging centers already have F18 scans in place. ( FDG for example)

I don't think the generator has to be on site, as with C-11. The halflife of Ge68 (which decays to Ga68) is 271 days.

LearnAll
LearnAll in reply to Tall_Allen

That's accurate...the long half life of Gallium68 does allow facilities to procure it from distant sites. However, the dose sold of Ga68 comes in a pair of 2..so the facility needs minimum 2 patients to scan once they break the seal of the Ga68 packaging.

Tall_Allen
Tall_Allen in reply to LearnAll

No, Gallium 68 has a short half-life - just 68 minutes. So they obtain Germanium 68 instead, which has a half-life of 271 days. Ge68 decays into Ga 68, so they use chromatography to separate out the Ga 68. They then easily chelate it to the PSMA ligand.

LearnAll
LearnAll in reply to Tall_Allen

The technician told me that once they open a package..they have to have 2 scans on same day. I was told that if the other patient does not show up or cancels, I will have to bear the cost of remaining isotope...then, PSMA Ga68 scan will cost me $600 in stead of $450. This price is from a top hospital in New Delhi.

Soon I will know a lot more about this scan..I am booking this scan every 6 months starting mid -2021 to monitor my Intermittent treatment.

lewicki
lewicki in reply to LearnAll

I am at the beginning of going off ADT. Am seeking all information I can get to do this. My doctors in my area so far are not really up to snuff .Can you tell me your Plans?Thanks

I think the guidelines have to be changed to tell physicians what to do with these new images. You cannot use the recommendations for standard imaging i.e. CT/bone scan with the results of a PSMA scan.

If you have surgery and they find positive nodes they put an N1 into the report but that's about it.

If you detect positive nodes with a PSMA scan you are metastastic and your oncologist will start ADT right away and not consider any different treatment for you, except adding Docetaxel or Zytiga maybe.

Will you be able to get Darolutamide? If you are non-metastatic castration-resistent and get a PSMA scan - most of the time they will detect at least positive nodes. So Darolutamide is not indicated any more.

tango65
tango65 in reply to GP24

If metastases are detected only by PSMA PET/CT and they are not detected by bone and CT scans, the cancers are not considered metastatic and the insurance companies usually pay for darolutamide.

GP24
GP24 in reply to tango65

That's how it should be. My observation is that doctors are not sure that you can declare the situation non-metastatic when you see the mets with a PSMA PET/CT.

6357axbz
6357axbz in reply to GP24

Once FDA approves PSMA Pet/Ct scan I think mets found with this new scan will define metastatic.

GP24
GP24 in reply to 6357axbz

All the existing trials are based on CT/bone scan. You cannot use their results for mets detect with PSMA PET/CT. You will make the wrong decisions when you base the treatment on these trials but use the results of a PSMA PET/CT for that.

6357axbz
6357axbz in reply to GP24

Treatments on Dx differ dramatically if it’s determined that the cancer has escaped the prostate to a distant location. I think FDA approval will confirm these mets are really mets, even if they don’t show up on traditional scans.

LearnAll
LearnAll in reply to 6357axbz

Yes...Mets are mets whether they show up on CT or MRI or PSMA scan. So Consumers will want all possible treatments whereas Insurance companies will want restrictions on PSMA determined mets to save money. There will be lot of competing interest as profits are supreme in a capitalist society. Big Pharma will like to sell most expensive medicines BUT if some one shows that on PSMA scan his mets have disappeared just with a generic bicalutamide (cost $17 a month) consumers will resist buying Darolutamide (cost $13000 a month)

This PSMA scan is a technology which has tremendous potential to cause serious disruption to the existing system.

WHAT IF ..a man can demonstrate on PSMA .. that his mets totally disappeared with a $ 5 a month herb or spice. Big Pharma revenues and profits can come under pressure. What about legal chaos.. patients coming after doctors for unnecessarily diagnosing them as metastatic or not diagnosing them properly when mets are visible on PSMA. Or somebody only had prostatitis but given chemo and Radiation but no evidence of cancer on PSMA scan.

And the best gift for consumers...take a bus to Tijuana Mexico in 2027 and buy one get one free PSMA scan just for $ 150. Present a coupon and get $10 off at the top.

Schwah
Schwah in reply to GP24

The consensus seems to be among virtually all of the top medical oncologist dealing with PC that the PSMA scan is without doubt the best and most advanced Imaging available today.

Schwah

tango65
tango65 in reply to 6357axbz

I agree, but they will need to do new RCT to determine which treatments will be beneficial. There is a huge difference in the tumor load between positive mets in PSMA PET/CTs and mets diagnosed by bone and CT scans. If you consider PSA in hormone sensitive cancer to be a rough estimator of tumor load, then there is a 30 or 50 times less cancer in a positive PSMA PET/CT if the mets were detected with a PSA of 0.2 instead of 6 to 10.

Tall_Allen
Tall_Allen in reply to GP24

AJCC defines staging criteria (and their recommendations are picked up in Canada and Europe. Their current (2018) criteria for N1 is based only on PLND (pN1) or enlargement seen on CT or MRI (cN1). They do not include PET staging of lymph nodes, and my guess is that they won't for some time. As it was explained to me by its author, they want the official staging to reflect what can be done by all doctors, not just the ones in top facilities. (That's why mpMRI is not officially used to stage clinical T stages.) What we might see change sooner is an expansion of what is called a regional lymph node (to include the common iliacs).prostatecancer.news/2017/03...

But unofficially, doctors who have it will certainly use it to base their treatment decisions on. This raises many unanswerable questions because all of the clinical trials to date, and those that we will have for some time, use bone scan/CT. So, for example, CHAARTED and STAMPEDE both found that men with newly diagnosed metastatic PC (M1 on bone scan/CT) benefited from early use of docetaxel - can one expect the same (or less or more) benefit if distant metastases are only detected on a PSMA PET scan? Will insurance cover such treatments? Darolutamide is currently only approved for non-metastatic (on a bone scan/CT) CRPC, so as long as it doesn't show up on a bone scan/CT, it will be approved.

I agree that there will be a steep learning curve for many radiologists. What usually happens (e.g., mpMRI) is that adoption exceeds expertise, and many patients will be misdiagnosed. Unfortunately, there is no required oversight in the US for this sort of thing. I expect that there will be training classes and manuals (like PIRADS) written, but there will be a great deal of interobserver variability. Fortunately, there are a few centers of expertise (e.g., UCLA and Johns Hopkins) for second opinions.

GP24
GP24 in reply to Tall_Allen

"I agree that there will be a steep learning curve for many radiologists."

The result of my biopsy five years ago showed prostate cancer and my urologist ordered a CT/bone scan. I thought, crap, I get a PSMA PET/CT instead of the bone scan, this is more sensitive. This PET reported several lymph node mets in the pelvis. Then I tried to get a treatment:

- the urologist said, you can not trust this imaging, let me do surgery this is the best you can do

- the RO said, if you have mets I do not want to radiate you, start with ADT

- the proton beam clinic said, we decided not treat patients who already have mets

- the Cyberknife clinic said we are not allowed to treat high risk patients who have mets.

So you better get a bone scan and keep the PSMA PET/CT under wraps.

lewicki
lewicki in reply to Tall_Allen

The Germans have been doing this for some time. So much for the great U.S. medical system.

Tall_Allen
Tall_Allen in reply to lewicki

PSMA theranostics started in Germany. Ra-223 for skeletal metastases was first developed in Norway. Taxotere was first made in Israel. Etc. That does not at all diminish achievements made in the US or anywhere else. Good ideas can come from anywhere.

lewicki
lewicki in reply to Tall_Allen

You are correct. Still all should be available for us to choose. Here in the US I was refused the PSMA scan even if I would pay $5000 ( 900 euros in Germany ) at the University of Michigan. Reason I still have a prostate gland. ???

Proflac
Proflac in reply to Tall_Allen

sorry my reply went without finishing. this looks like a useful review paper on theranostics practiceupdate.com/C/109315...

Proflac
Proflac in reply to Tall_Allen

Thanks. This looks like a good review of the use of these new the

Yes, and low tumor load, like oligometestatic condition, is the subject of a lot of trials and discussions in our medical community.

LearnAll
LearnAll in reply to 6357axbz

Researchers are going to have real good time coming up with what food items, what herbs, what spices, what minerals, what kind of fasting, what kind of water, what kind of life style...reduces tumor load and IT ALL CAN BE SEEN On PSMA Scan....And the proof. .printouts of PSMA scans will be all over pubmed...so no body can counter by saying "Yes..it lowers PSA BUT it is masking cancer" "Duh ...Show me the cancer ..Dude on the PSMA Scan. I just can't wait ! Nothing is masking nothing.. Bro ! I can see it now.

FDA won't be able to block this technology in other nations as they reeling under Covid 19 recession will like to cut down their medical budgets and will be funding research for cheaper but equally effective older meds and/or supplements etc.

Power of the "ScareCrows" will dwindle too..as patients and families themselves ..can see the extent of their tumor load on THE scans.

GP24
GP24 in reply to LearnAll

I had nine PSMA PETs by now. The smallest mets you will be able to detect are 4 mm in size, sometimes you see even smaller ones. But you have to expect that there are even smaller mets in your body you do not see and the single cancer cells in your blood you cannot see as well.

You will not be able to see any effect of herbs (except taxanes) or supplements on the size of these mets.

LearnAll
LearnAll in reply to GP24

Are these super tiny mets relevant at all ? Human Physiology textbook writes that there are millions of cancer cells circulating and present in organs in every human body at every moment. They are being destroyed constantly by immune system in form of Macrophages, Natural Killer cells and other phagocytes. In order to be threat to a person, there has to be a certain amount of cancer cells organized and growing after overwhelming the immune system.

So the new criteria will likely say " UpTo 2 mm mets on PSMA scans are considered "undetectable" as they harmless to the patient."

The bigger ones becoming smaller will be evidence of effective intervention, though.

GP24
GP24 in reply to LearnAll

These small mets will not kill you while they are that small. But if they are not killed by ADT, they will grow to a visible size. Then you can see these lymph node and bone mets. Also mets can seed further mets, one reason to destroy them.

I think you do not gain a lot when ADT makes mets shrink. Eventually the tumor becomes resistant and the same mets will grow again. So you just gained a shrinked met for some time. Is there a value in that? I don't think so. Better destroy the met with radiation, then it cannot grow again. It even cannot develop resistant cells. Different mets, which are not radiated, will grow though.

LearnAll
LearnAll in reply to GP24

IMO the real solution to these tiny mets is boosting immune capacity and having robust general health. Isn't that what kept us cancer free for decades of our life. ADT, Radiation, Chemo are all suppressing the mets while a weakened immune system keeps on allowing them to arise again and again. Many of these treatments do weaken immune system and therefore, we are left with no choice but to keep chasing these small mets with same type of treatments for rest of our lives. We are forced to become repeat customers.

Ultimate solution is going to be in Immune interventions...sometime in the future hopefully.

lewicki
lewicki in reply to LearnAll

Doesn't AC-225 and LU-177 kill all cells ?

LearnAll
LearnAll in reply to lewicki

Yes .They do. But the goal is not to let weakened body keep creating more and more cancerous cells. ..If we really want to win.

GP24
GP24 in reply to lewicki

No they do not kill all PCa cells. They kill what can be seen on a PSMA PET/CT. Smaller mets and single cells do not express enough PSMA for the Lu177 treatment.

GP24
GP24 in reply to 6357axbz

There are no randomized controlled phase III trials available yet how to treat an oligometastatic situation. Results regarding overall survival will be available maybe in 15 years from now. So the guidelines will not make any recommendations how to treat oligometastases any time soon. Except to treat them with ADT.

I get my mets zapped with SBRT because there is no randomized controlled trial yet to prove that it is beneficial to keep them.🙂

dhccpa
dhccpa in reply to GP24

You zap your own mets? Or those of others?

LearnAll
LearnAll in reply to dhccpa

Great Question ! In other words.. Buyer or seller ?

As far as delays for approval of Ga68 isotope production, if they approved PSMA scans with DCFPyL that uses F18 which most nuclear imaging facilities already have for other scans such as FDG and others.

My oncologist at Sloan said earlier in the year that by year’s end they thought it would be FDA approved but last month reversed himself and thought that would not happen it that timeframe- so who knows!!??

The doc who did my husband's PSMA Scan at UCLA on Oct. 27th said they expect it to be approved in December, but that it would probably take insurance 6 months to cover. Who knows? I really hope it does get approved so the next time my husband needs a scan for follow-up we can compare apples to apples instead of apples to oranges.

lewicki
lewicki in reply to mrssnappy

Time for FDA to sharpen up and get with what is going on in the rest of the world. I understand that the Germans have been doing this test for some time.

There is definitely something in the wind at the FDA. I have a Ga68 PET/CT scheduled at UCLA in about 2 weeks and they just made contact with me that I need to talk to the Doctor and 'consent me' prior to me going to get the scan. By the time I get the scan it may or may not be covered by insurance/medicare. Worst case I pay the $2800.

lewicki
lewicki in reply to cwu1974

$2800. Amazing. At University of Heidelberg it is 900 Euros or 900 x's 1.15 approx $1000 US Dollars. HMMM

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