Outcome of the TheraP Trial - So Much... - Fight Prostate Ca...

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Outcome of the TheraP Trial - So Much More than Overall Survival

marnieg46 profile image
22 Replies

Readers of this forum who found cujoe’s post of interest might find the podcast discussion with Michael Hoffman (see link below) interesting and helpful in providing a background and explaining some of the intricacies of the TheraP trial and why comparing the use of Carbazitaxel and Lu-PSMA-617 just can’t be reduced to a finite number or definitive answer about overall survival.  Many other factors need to be considered - not least of all quality of life.   

Prompted by cujoe’s post, I watched for a second time and was struck once again by the nuggets of wisdom, the considered discussion, the various nuances and clear explanations.    

If you prefer to miss the intro and ozzie chatter the 3 minute mark would be a good place to start.

    youtube.com/watch?v=vsCrZul...

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marnieg46 profile image
marnieg46
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cujoe profile image
cujoe

Ms. M, Thanks for PeterMac Podcast as a follow-up to the earlier MedPage Today post. Declan and Renu are fine podcast hosts and present the sort of joyful pleasantness that would make either of them a doc we would all like to see on a regular basis.

Lead researcher Michael Hofman calls attention to one of my current favorite topics for clinical research, Outliers. He discusses the short-comings of using Kaplan-Meier statistical modeling in regards to outliers. As something of a 2 x outlier myself, that resonates strongly with me and correlates with Siddhartha Mukherjee's Second of his (3) Laws of Medicine, from the book by the same name:

“Normals” teach us rules; “outliers” teach us laws.

Having had a PSMA scan earlier this year, one of the interesting discussion points was Dr. Michael Hofman's enthusiastic comment on the PSMA scan analytics presented by Dr. Andrew Armstrong from Duke. (@ ~16:20) In general, it seems Duke is using analytical software that evaluates PSMA results and provides information that can be used to guide treatment options (and outcomes) using a "SUV-mean" (average of all tumor SUVs) rating schedule. In the video, Michael discusses how the technique is done and the advantage of adding this measure of total tumor intensity to individual SUV values.

Michael's description of the manufacturing, supply, distribution, and handling issue with Lutetium agents is also very enlightening. especially in view of PSMA diagnostics and theranostics becoming more widely used. And lastly, Renu bringing up the cost for Lutetium treatments shines a light on the absolute cost and disparity between the per cycle cost of $6-7k in AU vs $50k in the US - and shows how irrational medical costs are around the world.

Good patient info on a developing treatment option that looks to be proving effective.

Hope all is well In the land of noisy kookaburras. I'll stick with my local Laughing Gulls.

Ciao - K9

d3is4me profile image
d3is4me in reply to cujoe

cujoe A great reply

cujoe profile image
cujoe in reply to d3is4me

Thanks - you do pretty well yourself 👍

GeorgeGlass profile image
GeorgeGlass in reply to cujoe

what kind of treatment options does this help with? Armstrong was my doctor for a few years.

cujoe profile image
cujoe in reply to GeorgeGlass

George - Have you had a PSMA scan? And are you still hormone sensitive or CR? Metastatic?

Currently in US Pluvicto (Lu 177) is approved for mCRPC patients who have been treated with ADT + chemo ONLY. Hormone sensitive people are treated in one or more current clinical trials ONLY.

Here is the FDA notice from earlier this year:

fda.gov/drugs/resources-inf...

PSMA scans were approved by FDA last year and are now widely available at major cancer centers in the US. Depending on your current status, a PSMA scan would be a first order priority.

Good Luck,

Ciao, Capt'n K9

lokibear0803 profile image
lokibear0803 in reply to cujoe

Hi cujoe — listening just now to that section about costs, I’m wanting to make sure we’re talking apple to apples. What I heard is this:

out of pocket self-funding in AUS is $6-7K/cycle, whereas reimbursement in the US is $50K.

So the self-funding thing I understand, but what exactly does he mean by “reimbursement”? Is that some accounting stuff that’s done when insurance is involved, and wouldn’t really concern me? All I really care about is my out of pocket…btw, I’m Medicare if that makes a diff.

Thanks!

cujoe profile image
cujoe in reply to lokibear0803

Loki- A good question - for which I do not have an answer. If Pluvicto treatment progresses like PSMA scan reimbursement, once the FDA approves a procedure, Medicare and other insurance companies will start covering the cost. There is always some lag time and I have not seen that Pluvicto is yet covered by Medicare, but I haven't been looking either. (So that might already be the case - for previously chemo + ADT patients only, of course.) I am mHS, so I haven't yet had reason to look at coverage.

Good Luck - Ciao - K9

MateoBeach profile image
MateoBeach in reply to cujoe

”Tan me hide when I’m dead, Fred. tan me hide when I’m dead.MOs So they tanned me hide when I died and that’s it hangin on the shed.”

Perhaps on the shed (many years from now) with the caption “ Glad I got Lu-PSMA early on (low burden, HSPC) when my Overall Survival could not even be estimated. And for that, among other reasons, I lived a happy long time” .

Just saying: get it if it’s a good fit. Earlier rather than saving it for later when more advanced. Just one opinion.

cujoe profile image
cujoe in reply to MateoBeach

I'm not quite there, Señor Mula - but that Lutetium stuff is a very bright light shining in my direction. Maybe Ms. M will adopt me and take me back to AU with her when she comes to visit in 2023?

marnieg46 profile image
marnieg46 in reply to MateoBeach

Think those at the cutting edge at Peter Mac and St Vincents here... and many others in this field around the world too... would agree with you Paul. Earlier rather than later will be SOC some day... just like its use prior to surgery (now being trialled).

I note the response to you from The Captain, gives the impression he might need little encouragement when the time is right. Won't be Firedoor for him though will it? I'll have to check out someplaces more suited to his preferences.

Thought some might miss your reference to the song lyrics from this iconic ozzie tune...and in the spirit of political correctness...have chosen a link with a video that mostly avoids visuals of the songs writer...

youtu.be/H1FbAsFX8sA

NPfisherman profile image
NPfisherman in reply to MateoBeach

Pabilito,

One of the factors in regards to success with PSMA tx is the SUV scores on scans prior to tx, and the level of success based on those scores. As discussed in the video, PSMA provides a high QOL tx vs cabazitaxel.

As the K9 Terror says, " Give me QOL over quantity", which is another reason I do not advise chemo in low volume disease. Posters that advise early chemo in low volume disease do not consider the SE's with chemo.

I look forward to your continued updates on your journey post tx.

D1 

MateoBeach profile image
MateoBeach in reply to NPfisherman

Dangeous 1, sorry I’m slow to get back to you on this.

The high PSMA SUVs of 10 or higher predicting more likely good responses are specific to Pluvicto (Lu-PSMA-617). These and similar small-molecule ligands do not have high and persistent binding to PC cells expressing PSMA. They are loosely held, which is why 2/3 of the isotope is gone from the body by 24 hours (or so). So high SUV improves the odds of them decaying on PC cells before they are washed away by the kidneys.

In contrast, monoclonal antibody ligands bind strongly and persistently to the PSMA embrace protein. So they can have more effect on small micromets with low SUVs and perhaps even circulating cancer cells. My own SUVs on sub centimeter LNs were all less than 2, And I had a good response with a 65-70% drop in PSA from my 2 injections of Lu-J591. Weill Cornell who developed that ligand kept rights to it for use with Ac225. Currently enrolling phase 1 dosing trial with it. (Wish I qualified for it but only for mCRPC.) Bayer is working on their own PSMA monoclonal antibody ligand I understand.

Agree completely with you regarding chemotherapy in low volume disease. Pablito

NPfisherman profile image
NPfisherman in reply to MateoBeach

Pablo,

Thanks for the clarification. I wish I had known of Lu-J591 when I did SBRT the last time, and had time to plan for it. Oh well, I'll keep it on file...

Have a great weekend,

Dave

NPfisherman profile image
NPfisherman in reply to MateoBeach

Pablo,

My one lesion was SUV of about5 as I recall prior to SBRT. I will watch Lu-J591 for treatment possibilities. You planned your tx well, and hopefully will reap solid rewards from your approach.

Fish

marnieg46 profile image
marnieg46 in reply to cujoe

I think Declan and Renu are simply delightful. So down to earth with a touch of fun.

Of course I knew that Michael's points would have a resonance with your own thinking and views. How good to hear experts in their field openly and seriously explore considerations outside the normal SOC.

d3is4me profile image
d3is4me

Thanks Marnie A Great Video many very interesting valid points that are important to all with PC. I find your reply to Paul 14 days ago "astounding and definitely outrageous that in a country were some of the leading research in pc is conducted and globally acknowledged "so appropriate when many oncologists and urologists are not up to date with the latest treatments and trials and costs effect the treatment we receive

Ross

marnieg46 profile image
marnieg46 in reply to d3is4me

Yes Ross it's amazing isn't it. I think a urologist once explained it to me that made sense and reflected our experience. He said that some urologist, once they start treating a patient don't like giving them up. Not for any financial benefit but it's a sort of 'ownership' mentality and they've developed this relationship with you and they think they know what's best for you. And you're definitely right... and I think this might have come up in the video... that many urologist really aren't properly across the best treatments because basically it's not their area of expertise. I'll also PM you later.. hope all goes well in the State of Sunshine

d3is4me profile image
d3is4me in reply to marnieg46

Hi Marnie,

Along with many interesting points the discussion on the toxicity of chemo and QOL is very important also believe Michael does a more comprehensive assessment of potential LU patients than any other oncologist.

I think we all need to learn from other forum members and professionals like Declan and Michael to enable us to decide on your treatment and QOL best suited to ourselves.

Marnie as you have previously said find and oncologist that is conductive to your request.

For interest I have attached a small portion of my MO's patient care statement

Ross

Black White text
marnieg46 profile image
marnieg46 in reply to d3is4me

Ross, he sounds like just the MO you were seeking...makes such a difference when you have confidence that the treating doctor will at least listen and take your opinion into account.

d3is4me profile image
d3is4me in reply to marnieg46

Marnie

You are correct he is a great guy

Ross

NPfisherman profile image
NPfisherman

HI Marnie,

Thanks for posting another Peter Mac video with Declan and Renu. They are entertaining and informative. Sorry I haven't written lately, but the push is on for the Victorian project getting painted before winter. The painter can't hold on to employees. I have been trying to hire people/ contract to help fix some issues, but that is no good. Today, I finished framing and replacing a window. More work tomorrow. I may be the painter's apprentice in the morning...lol. Repairing the porch in the afternoon.

Dangerous Dave

marnieg46 profile image
marnieg46 in reply to NPfisherman

Glad you're getting all the hard outside work done before the real cold sets in. Keep at it and you'll be finished in no time. Fortunate the Victorian isn't located in Sydney or you'd never get the painting done..it never seems to stop raining for long enough to do much outside...certainly not external painting.

Yes I really like listening to Declan and Renu and as you know Declan has helped us smooth out some tricky treatment issues and Ron not even his patient!

No doubt we'll 'talk' soon because I'll update you via PM on a few developments...you always have the best medical information...when I'm unsure...

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