Scans 16 weeks into Lu 177 (2 infusions)

[noahware]

Began Novartis Pluvicto trial in early April after failing ADT+abi at about 6 mos (following failed tE2 attempt which saw ALP soar to over 1000, w/ rapid progression of extensive bone mets).

The first straying from the trial protocol came with the production delay of Pluvicto, so my second infusion was pushed to 8 weeks rather than 6. The second straying from protocol came with me getting COVID, so third infusion was also pushed to 8 weeks (Aug 1) rather than 6 weeks.

Labs some time after the first infusion initially showed PSA dropping from about 25 to 2.4, but rising by the time of second infusion to 14 and now, at time of third infusion, to 33. ALP went from mid-300s to 187, now back up to 308. Nothing else of note in blood markers.

Bone scan eight weeks after infusion #1 showed "new focal area of uptake involving the left aspect of L2 [with other] increased confluence of radiotracer avid lesions. Several areas of uptake appear slightly less intense on today's study... [compared to scan done on 2/23/22]"

Latest scan at infusion #3, eight weeks after the scan above at infusion #2, is now showing "[new] focal uptake within the occipital bone... Otherwise essentially unchanged multifocal osseous metastatic disease."

My MO says the new spot is "tiny." (Hey, the skull is just another bone, right? What's one more?) He had no reservations, unlike me, about moving forward. True, things are not getting better YET. But?

So number 3 is in the books. On top of my slow COVID recovery, it provided a miserable week of nausea and fatigue. Is there any indication or hope that things may still turn around here?

Obviously it's time to think about next steps, but should I be considering the initiation of a different treatment even before the next infusion is due in mid-September? There will no scans prior to that, and I'd think I'd have to see some pretty sweet PSA and ALP numbers over the next five weeks to give me any confidence in remaining in this trial. Thoughts?

[Still no pain associated with these osteoblastic lesions.]

[Tall_Allen]

Have you had Provenge? There may be a synergy with Pluvicto.

[noahware in reply to Tall_Allen]

Interesting. I have not had Provenge, but I am sure that would not be within the trial protocol. I could always get my 4th infusion, and the go try Provenge a few days later (with a different MO, lol).

Is it reasonable for my MO to seem fairly confident that I should carry on with the trial for now? He seems far less worried about the new skull met(s?) than I am!

My impression going into this was that one often needs to go at least three sessions to know for sure. Obviously I'm not getting the low-percentage home run on the first pitch, that I was of course hoping for, but nor does the treatment appear to be killing me outright... but killing me softly?

[Tall_Allen in reply to noahware]

Provenge has been successfully combined with Xofigo, so it probably has a similar synergistic effect with Pluvicto:

ncbi.nlm.nih.gov/pmc/articl...

But you are right that it doesn't conform to a SOC protocol, so you will probably have to wait until Pluvicto is done.

The occipital met was PSMA-avid, so maybe Pluvicto will get it too.

When Pluvicto is done, you can also start Xofigo (+Provenge).

[noahware in reply to Tall_Allen]

The scans being used in the trial to monitor progression are just normal bone scans, so how would we know the occipital met is PSMA-avid?

This was in the back of my mind going into this trial, that I might not know much beyond the simple fact that I begin by knowing I have enough PSMA-avid cancer to get an admission ticket. From there on, is it all in the dark for me? (And for them too, lol?)

Not that my kinda crappy insurance would help me enough to pay to monitor the ongoing nature of my mets with FDG scans and PSMA scans as I proceed through the trial, but it would be kind of weird to get those done at Dana Farber even as I was in their trial that was NOT providing them.

It has occurred to me to say to my trial contacts, hey, I would feel a lot better about going forward with the second half of the trial only after getting these additional scans, and since my and insurer and I don't really want to pay for them, would Novartis mind handing a little more cash to Dana Farber to cover them?

[Tall_Allen in reply to noahware]

Well, I guess you will know if it shrinks it is PSMA avid.

[tango65]

Did you have FDG PET/CT? What was the highest SUV in any metastasis? I ask because you can get an idea how the response to LU177 PSMA treatment is going to be using this information.

Consider requesting a biopsy to do histological, IHC, and genetic studies of the cancer. It could help to plan further therapies.

[noahware in reply to tango65]

Thanks. I did speak to my MO about going forward with genetic testing of the mets.

Because this was a trial, no FDG scan was offered and the specific results of the qualifying PSMA scan were not revealed to me. (There certainly is no incentive for Novartis to push men away from trying Lu-177 on the basis of FDG discordance.) So I am in the dark about that.

Is it reasonable to assume that even though I had plenty of PSMA-avid cancer, to qualify for the trial, I must have plenty that is not? It is frustrating to debate moving forward without a compelling data-based case for or against.

[tango65 in reply to noahware]

If your insurance pays for a FDG PET/CT and a PSMA PET/CT you could get them even when you are in a clinical trial.

Since you are not changing any treatment you do not have to inform them.

Using the results of the studies you and your oncologist could make the decision of dropping from the trial and doing other treatments.

I dropped from a clinical trial after having problems and consulting with a MO and an expert in immunology.

[noahware in reply to tango65]

I do not have the best coverage. Already feeling close to being in the poor-house, anyway.

[KocoPr]

I sincerely wish I could give you advice but this way out of my knowledge base for now until i fail my ADT. I wish you hopeful news on your upcoming infusion.

[noahware in reply to KocoPr]

Thanks!

[Metaldraft]

Wishing you the best the more data the more of future directions ….did or do you want to challenge the second and third opinions arena?

[noahware in reply to Metaldraft]

Thanks. Do you mean, to consult another MO regarding how things look? I think he/we would need more data, per the scans tango65 mentioned.

[Metaldraft in reply to noahware]

Yes just to make sure everything or everyone are looking at that in concert and interesting how some docs visualize a diagnosis and treatment …..you are your best advocate for future results and treatments

[noahware]

Under MO supervision, we began with something approximating a PATCH protocol and kept adding more patches when T failed to get low enough. Even with very high measured E2 levels, after well over two months T never got below 80 or so.

In the meantime, ALP soared. My suspicion is, the high E2 and low-but-not-castrate levels of T combined to be a super-promoter of the growth of osteoblastic bone mets, which are now extensive.

[Ramp7]

Last month I completed the 6 infusion trial at Dana Farber conducted by Novartis. They used a Cat Scan with contrast along with Bone scans to monitor disease progression. PSA went from 8.1 to 0.19. Then slowly crept up to 0.5. One new hot spot on tail bone picked up. Radiation scheduled Nov. 14 to this one spot. It is believed that is responsible for slight uptick.