New Lu177 trials in Australia

[GP24]

I looked through the slides of Prof. Hofman which he presented at the APCCC 2019 conference in Basel. In Australia they are starting a lot of interesting trials using Lu177, now that the well known VISION trial has been closed for new patients. Maybe some of our Australian members are interested to take part in these trials.

The question these trial try to answer is whether the Lu177 therapy can be used earlier than after all conventional treatments failed. Prof. Hofman und colleagues apparently think that is the case.

up.picr.de/37234858cp.png

There is the #LuTectomy trial for patients presenting with lymph node metastases before surgery has been done. These patients will get one to two cycles of Lu177 therapy followed by surgery with extended lymph node dissection. up.picr.de/37234863ge.png

The #UpFrontPSMA trial is treating hormone-naive patients presenting with high volume metastatic disease with two to three cycles of Lu177 therapy followed by ADT and Docetaxel chemo: up.picr.de/37234873ob.png

The PRINCE trial is combining the Lu177 therapy with Immunotherapy (Pembroluzimab): up.picr.de/37234878hz.png

Then there is the LuPARP trial combining Lu177 therapy with Olaparib: up.picr.de/37234881vy.png

The slides of his entire presentation can be found here:

apccc.org/fileadmin/files/2... and a video of his presentation is here:

urotoday.com/center-of-exce...

[GreenStreet]

Very interesting. Thanks for posting these links. An area that is well worth keeping an eye on and potentially showing a lot of promise.

[Fairwind]

I find it amazing that these trials are taking place in Australia and not the U.S. Are these trials being conducted by the Australian Health Service or are they sponsored by a private corporation that's trying to get a patent on the treatment? There is a LOT going on backstage with LU-177. Lots of wheeling and dealing..

In the States, a small biotech company, Endocyte, started the Vision trial and got into problems keeping the control group enrolled in the trial as there was really nothing there for them. Then Novartis, a huge Swiss pharmaceutical company purchased Endocyte for 2.7 Billion dollars and had little choice but to continue the poorly designed Vision trial. They did close the trial to new applicants..With very few participants in the control group, the original goals of the trial will have to be modified in hopes of still getting FDA approval based on the results achieved by the group getting the LU-177 compound..

Meanwhile overseas hospitals and research labs are and have been using Lu-177 to treat patients if they test positive for PSMA and they have the cash...... A strange situation indeed...

[GP24 in reply to Fairwind]

Fairwind,

this are phase I and II trials which do not cost as much as a trial to get a new drug FDA approved. The sponsors are mentioned on the images I linked and are different for each study. Mentioned are Movember, Endocyte, Merck, AstraZeneca, Prostate Cancer Foundation and more.

[Chask in reply to Fairwind]

These are private trials, BUT, the Australian government has made available $12M to assist with these trials, see au.movember.com/story/view/...

[GP24 in reply to Chask]

Thank you for the link. However, the Movember article mentions a trial by Prof. Emmett combining Lu177 and enzalutamide and a trial by Dr. Corcoran for PCa prognosis and treatment. These do not seem to be the trials I provided links for.

[Fairwind]

These trials / studies are very small and usually held at just one location. The system used by countries with nationalized healthcare is somewhat different than our private for profit system ....

[GP24]

The #UpFrontPSMA trial will be offered at 11 clinics in Australia, the #LuTectomy trial will be offered even at the Atlanta VA Health Care System, USA: twitter.com/DrewMoghanaki/s...

I think the #LuTectomy trial could show the future of standard of care for prostate cancer. You will have a PSMA PET/CT before surgery and many patients, I guess about 30%, will show lymph node mets with this sensitive imaging technology. Then these patients will be treated with Lu177 to zap these mets and shrink the tumor in the prostate followed by surgery. This will result in much fewer or later recurrences than currently.

[immunity1]

Thanks for sharing GP24. Interesting trials. If I was to turn back the clock it would be early intervention with Lu177.

[Fairwind]

I'm a Vet and I get much of my treatment through the VA healthcare system..But clinical trials and experimental drugs and treatments ? I don't think so.. If it's not the approved "Best Standard of Care" they don't do it..

Whatever they do in Atlanta, they would do in ALL VA medical centers..

I was under the impression that Novaris held the patent on Lu-177 / PSMA617 at least in the United States. Until the FDA approves it (2 years if we are lucky) you won't get this treatment in the States unless it's part of a recognized trial..

[GP24]

Drew Moghanaki is associate professor at the Department of Radiation Oncology, Emory School of Medicine, Winship Cancer Institute and section chief, Department of Radiation Oncology, Atlanta VA Medical Center. So I assumed he meant what he was writing.

A few VA Healthcare Systems did take part in the VISION trial.

[marnieg46]

I'd like to add my thanks to your post. We found it very interesting to watch the presentation and we're pleased that so much research is going on especially in our own country as there's no doubt it is only by trials such as those discussed that this condition will be overcome.

[Bangkok]

Yes. I'm living proof. I had 3 treatments in Bangkok after only two weeks of hormones. Here is a copy of my bloodwork starting in Dec to August 2020. the four months missing are the time in Bangkok receiving three treatments.

Interior Health Portal .ca

Result History

Prostate Specific Antigen Total

Results

20/08/20 8:40 am0.10 ug/L

13/07/20 8:32 am0.16 ug/L

15/06/20 8:29 am0.14 ug/L

06/01/20 1:56 pm889.76 ug/LH

11/12/19 11:16 am985.49 ug/LH

02/12/19 3:23 pm993.29 ug/LH

[u302000]

GP24,

Would you consider sharing your path to LU-177 treapment?

healthunlocked.com/advanced...

Cheers,

Buddy