New Trial for Stage 4 PC

The trial number is NCTO3511664, the "Vision" trial. Similar to Radium 223 but it SEEMS to work much better..The radio isotope involved is Lutetium 177. In Australia where a trial is underway, results have been spectacular, like Zytiga was when it first came out..There are stunning scan photos in the second link posted..


/clinicaltrials.gov/ct2/show/NCT03511664

www.snmmi.org/NewsPublications/NewsDetail.aspx?ItemNumber=29483

Those pictures are worth......well they're priceless.

German researchers have been working with LU177 for several years and they presently use it for palliative care. It still holds lots of promise in becoming a huge tool in the fight against prostate cancer. Stay tuned.

Woody

Just a note about this trial; I had inquired about a Phase II trial on this drug just before this Phase III came out- same people running both trials- I asked about cost to patient- patient was expected to absorb the cost of the PSMA-Gallium 68 scan (to see if your tumors had the PSMA marker) at $7000 AND the cost of the isotope at $10,000 per injection- I do not know if this holds in the Phase III trial just announced-

Now, is your insurance gonna cover that? probably not, unless it is Medicare- next year for me maybe, but then what if you get randomized to non-treatment? Ouch- take one for the team?

there is a new Phase I/II trial of PSMA-Lutetium177-R2 (the R2 is a different molecule than the 617 just a bit, but both target the PSMA receptor)- this is running in Phoenix AZ, and costs are absorbed by the drug company- when my Zytiga fails, I hope to try and get into this one-


careful on this drug though- it targets anything that has PSMA on the surface, and that includes kidneys and salivary glands- dry mouth (xerostomia) can be a side effect....


rf

Rockyfords posted that this trial had some heavy expenses that would be charged to the participant but I contacted the trials sponsor, Endocyte, and they are covering the costs of the trial 100% including any scans...

Here is a recent press release from the company:
Endocyte intends to use the net proceeds from the proposed offering, if
completed, to fund the continued clinical development of its pipeline products
and preparation for the commercial launch of ^177Lu-PSMA-617, if approved, as
well as for working capital and general corporate purposes.

Good news on the cost to patient. Keeping my eye on this one.

George, did you open the second link in the opening post ?? Yes, I suppose researchers can be expected to put their best foot forward..The study you quoted seems to be European in origin, German mainly..These "studies" are run a lot looser than the clinical trials used in this country..Your article pointed out some serious toxicities that I have not seen elsewhere..

Post Edited (Fairwind) : 9/13/2018 3:31:41 PM (GMT-6)

Fairwind said...
These "studies" are run a lot looser than the clinical trials used in this country

How did you determine that? Are there any US trials published which are "tighter"?

Fairwind said...
Your article pointed out some serious toxicities that I have not seen elsewhere

Which articles did you read that reported fewer toxicities?

George

In Germany the PSMA treatment is done after Zytiga or Xtandi have failed and the patient had a Chemo already. If the patient refuses Chemo, he can get the treatment after Zytiga or Xtandi have failed. This is outside clinical trials. Many patients refuse the Chemo since they expect better results and fewer side effects from the PSMA therapy.

I looked at the side effects mentioned in the review by Awang which I provided a link for above. Side effects mainly occur when the treatment is repeated. So patients usually report side effects from the third cycle onwards.

The most common side effect is a dry mouth since the salivary glands get a hit. This can also occur with the lachrymal glands but the patient usually will not notice that. Some patients try to avoid a dry mouth by getting the glands to produce a lot of saliva using lemon and chewing gum.
The kidneys also accumulate a lot of the drug. But side effects from that do not occur that often and are a temporary side effect.
Finally myelosuppression. In the review they mention two studies for that. The study by Ahmadzadehfar did not report this side effect. The second study by Rahbar reports this side effect in 12% of the patient group. However, they also mention: „Although the patients in our study were heavily pre-treated and received 177Lu-PSMA-617 RLT as the last therapeutic option....“ So I think this may be caused in part by e.g. Radium 223 treatments these patients had received before the PSMA therapy. Rahbar et.al. mention: „The present study shows significantly lower hematotoxicity when compared to results of second line chemotherapy or radiolabeled antibody therapy“

If you progress on Zytiga/Xtandi, the subsequent treatments all have significant side effects. My understanding is that the PSMA therapy has the fewest side effects of these.

George

Fairwind,

maybe you can sign up and already get the staging PSMA PET/CT done already. You may also be able to start the treatment at some location and then move to Denver for additional cycles when they are ready.

This is what I expect they will do:
- initial meeting discussing the treatment
- lab test and PSMA PET/CT for staging - wait up to two weeks for written report
- first shot (cycle) of Lu177 PSMA including a few days in hospital for observation
- lab test after three weeks
- second shot after six weeks
- and so forth
- new PSMA PET/CT after four cycles

Or you are randomized into the control group and don't get the treatment.

Or choose a different study without a control group.

Here is a link to a review comparing SOC third-line treatments with PSMA therapy.

George

Post Edited (George_) : 9/16/2018 2:22:18 AM (GMT-6)