Novartis announced a new international Phase 3 clinical trial slated to begin 3/5/21 for men with metastatic hormone-sensitive PC. There will be a crossover after SOC failure, so everyone will get the drug. They haven't announced the sites yet, but with a sample size of 1126, I expect it will be the same as the VISION trial.
They had previously announced a new trial for men who are castration-resistant and have failed one second-line hormonal agent, but have not yet used chemo:
Thanks TA for posting this. I am on a clinical trial at MSK and taking ADT(Firmagon) and HS, do you think I can apply for this one? Will MSK agree? Thank you.
Wow, I just questioned recently why there are so few trials with hormone sensitive guys. Couple of quick questions: Did I read correctly that if you are currently on Lupron you don't qualify? So for me I'd have to stop for 12 months to qualify. Is it the same for Zytiga/AA?
They want relatively newly diagnosed, so they only allow 45 days of ADT. They allow up to 45 days of Zytiga too. Because they require evidence of PSMA avidity, they don't want it hidden by long-term ADT use.
Of course, makes sense. My PSA is currently <0.01 so a scan would show nothing. But if LU-177 works it is great to see this trial done earlier. So many seem to wait too long.
In December 2019, I was diagnosed with mPC. Initial PSA was 46 and Gleason 8/9. Positive in the lymph nodes but no mets in bones. I have been on ADT for 13 months and Xtandi for 9 months. I had radiation treatments last Spring. Currently, my PSA is < 0.1.
Please explain the statement, "There will be a crossover after SOC failure, so everyone will get the drug".
Given my current good state, is this something I should consider at this point in time or hold off for a later date?
They do allow adjuvant ADT for up to 2 years; however,they allow LN metastases if they are non-pelvic (stage M1a) and at least 1.5 cm and they are present 28 days before you start the trial, so I doubt you'd qualify.
The crossover means that those patients who are randomized to get standard-of-care will get the Lu-177-PSMA-617 treatment anyway after they show signs of progression.
I am showing my lack of knowledge but have to ask - is this a major game changer for men with APC ? Using the over- used analogy of horse out of the barn , would this stop every horse that left? 🤷🏻♀️
I've grown to hate that phrase. Every time I see it used, it seems to be about a development that adds, at months to survival rather than a longer indefinite period.
hi Tall_Allen, I have just before Xmas been diagnosed, and i am about to undergo Eligard, SC inj. 22.5....3 monthly inj. plus RT, EBRT therapy after six months of eligard, in my case Gleason (4+3) 7, slight seminal ves, involvement, iliac node, and pelvic side wall node, 25 samples, with 24 pos, Psa 138, DtRe-3 pi-rads 5, psma pet-ct, but no iodine contrast for ct, just the radio dye for pet, mri showed prostate 55cmm, some neural involvement, treatment palliative eligard 22.5, 3 month, locally advanced prostate, i have read up on side affects and am a little worried as i have just been diagnosed with type 2 diabetes at the same time as prostate cancer, and just started taking metformin modified release, 500.
I am 72 years old and worked all my life as an electrician and security installer, now i have retired, my mum and dad died at age 58 with myocardial infarction, and my sister had her first minor heart attack at age 62, but no prostate cancer, in my Family history that i am aware of, is there any side effects that you, or any of your colleagues may have experienced, using Eligard, or lupron, in their follow up treatments, and have you heard of alternate therapies such as...Aloe-Emodin, ....ganoderma-(reishi mushroom), Essiac, coupled with Cbd oil, and thank you again for any help you may offer, as i am a new member to this site, and best regards for now.
Yes, I have heard of those alternate therapies. They do not work. You will die more quickly if you use them instead of Eligard. If you want to take those in addition to the therapies that are known to be beneficial, it may improve your peace of mind.
The only way to slow down death is to add other therapies to Eligard, either docetaxel or one of the second-line hormone therapies (Zytiga, Xtandi, or Erleada) that have been proven to increase survival in men with your diagnosis.
TA- you are the bomb 💣 for your research and support. 🙏. May you be safe, happy, healthy and live with ease
Although my MO disagreed with my assessment, that mHSPC patients seemingly must wait until the disease progresses, and sometime that the second line hormonal therapy fail, in order to qualify for some of these trials, it's appears as that's exactly what they do. It's unfortunate for those of us currently fighting...
I'm newly diagnosed as mHSPC... And my question during my last consult with him discussed this very point. How chosing a path, potentially excludes you from other later. Big difference with low grade, low burden disease patients is the luxury of time!
These trials, should include a separate arm, tracking patients outside the protocol, if anything to see if there are hypothesis being overlooked! The standard of these drugs being used in late stage care, then slowly brought in to earlier phases of progression is a slow and exhausting paradigm! We are reacting to studies started a decade ago and those patients numbers and tracking being formulated today. And yes, they are allowing for great inroads for patients to use drugs unavailable to their staging just a year or two ago.
Arrrrgh... I know I'm spitting in the wind here, just rambling now, apologies
Thanks for posting, is interesting and certainly good to keep an eye on.
They always start with the sickest patients first because (1) it is most ethical and (2) it takes less time to get results and approval. Novartis is starting these trials even before FDA approval. That is a risk for them, but hints at good results to come from the VISION trial. The good news is that the FDA is now allowing median radiographic progression-free survival as the primary endpoint, considerably speeding up the process.
TA, seems like 45 days of ADT is very narrow, almost like you would have to be in that short window of time where you were diagnosed with metastatic disease and considering ADT as a next step but have either not started it or just started. Most guys are just trying to manage SOC and next steps, let alone considering a clinical trial at this point. Do the folks who are running these trials just hand pick who they want and reach out to them via their MOs? I'm curious how this works. My husband has had 65 days so wouldn't qualify even it was available an something to consider.
They are really trying to get newly diagnosed patients. They are trying to prove that Lu-177-PSMA-617 is as good as a first therapy as chemo, Zytiga, Xtandi or Erleada. Once they can prove that, it would take its place as a new standard of care.
Just finished my third and final cycle of Lu-177. All mets are gone( with one exception) and PSA 0.62 just before third infusion. I did have one met on scapula which was the largest and it is barely seen on PSMA scan. Dr. Sen feels strongly that it will not require external beam radiation. The third infusion dosage was reduced. Until other therapeutic modalities surface this looks like a game changer when coupled up with PSMA scanning which is now becoming available. The three metrics that is considered. 1. Clinical picture...Pain...In my case it was gone 30 hours after first infusion with multiple mets, spine, humerus ,scapula, pelvis and one node). 2. Blood chemistry to include PSA ( my PSA started to drop and never bounced ). 3. Scans continued to show tumor reduction.
I feel that if we can get the PSMA scans early it will give everyone a more clear choice as to their treatment plan. Charlie and I chose this path because our options were shrinking and Patrick Turner had a big impression on my OC whom was involved in the VISION trial. This was a doable choice but it takes some determination. It will become easier once a Covid vaccine is here for travel but still doable today. Now that PSMA scanning is here I would encourage one to stay on top of it and if you are early in treatment ,consider checking on the trail that Tagawa has underway. I would have loved to been included but did not qualify because finally my mets showed up on standard scans....Blue Skies and Tailwind always
I posted this here since Lu-177 is getting to be a hot topic .
I agree with you Pilot about the PSMA PET scan helping us if done as SOC like it is over there. When I had my first PSMA PET scan over there in March, 2017 it made me really fell I was doing the right thing in regards to treatment. Just wish they were the same price here or even half the price. I paid between $300-550USD for the five I had in Delhi. If and when my PSA goes up, and I am inclined to say when it goes up the very first thing I plan on doing is flying to see Dr. Sen to see if I am PSMA avid and hist it hard immediately to hopefully give me some more quality time. Never thought I’d be here 6 1/2 years after dx’d with a PSA of 212 and Gleason 9. I also want to try stem cell treatment that they have there for diabetes. After I had the tumors melt I had it in Ahmedabad, India for my knees. It actually made a big difference in my knees.
Great news to hear that they are starting this now as it will likely lead to approval (hopefully) for earlier HS disease where it can likely be even more effective. Wish they had done that with Provenge way back when.
This sounds promising for those that haven’t done more than the 45 days of ADT. After the conversation last week about the guys that went to Delhi for it sure makes a lot of sense to try this in a trial. Best of luck for anyone able to access this trial.
Yeah, I know Denmark is also participating in the VISION... I will ask my MO.. Even though it will most likely not make sense for me (I am still hormone sensitive but have been on ADT for 14 months)..
India and Isreal accepted me for Lu-177. I am chemo naive and had a PSMA scan to submit. If you do not have access to PSMA scan they will do one on site. These are not clinical trials but actual therapy...It is a simple 5 step process to go to India and if you follow the steps it can be accomplished easily with in a 4 week time period. Charlie and I got it done it less than 10 days but it is a whirlwind process....just allow yourself some time we can help...Blue Skies Sky King and Penny (woof) Todays check...Charlie PSA 0.00 mine down to 0.42....and dropping
Thanks for sharing. I can get PSMA PET/CT scans in Denmark where I live for free... It is just difficult to get them. As for Lu177, fortunately I can get them several places in Europe within 1,5 hours flight (e.g. Finland, Germany, UK, Austria) if I pay the whole things myself. But so far, I have un-detectable PSA (<0.10) and not very much PSMA showing on scans, and that is what Lu177 need, so at this point I don't think Lu177 is the way to go. I have a follow-up PSMA PET/CT in 3 weeks, so we will see how it looks.
Thanks for you information. How did you determine which facility is best for you? What are initial steps in making contacts and planning for the treatment. Thanks so much!
There are many questions that need to be addressed. India is currently a no-go due to Covid. They are now locked down...please message me if you are actually going to seek Lu-177. I need to know what home work you have done . I do not want to repeat what you may already know. Blue Skies.
I read through the qualifications for this trial, they mention ADT and ARDT in standard of care but do not mention radiation treatments
As I understand Lu177( very limited knowledge so far) it inserts a radioactive isotope into cancer cels that have PSMA receptors and kills them. IMRT kills cancer cells with external radiation.
Do you see a way that LU 177 could eventually be used early in cancer treatment as an alternative to IMRT?
You still didn't answer my question: radiation to WHAT? to metastases? to the prostate? I assume you mean to metastases since SOC currently includes prostate radiation for oligometastatic patients. If so, radiation will probably still be used palliatively on the larger metastases just as it is with Xofigo. I doubt that will change.
Thanks for jumping in, sometimes I am not clear.MY question is: At some point could LU177 be used instead of external radiation in newly diagnosed men.
I ask this because it sounds like LU177 goes after all cancer cells where as Xofigo only goes after cancer in the bones.
Is this why Novartis is opening a trial for hormone sensitive men
Well my pea brain will struggle to put an answer into words. Hopefully you can direct that to TA.One thing Lu 177 enters tumors to a certain depth so external is sometimes still needed.
Also it might be only anecdotal but it seems actually to work better on lymph nodes.
Exactly, so are they thinking that LU 177 could be effective against all cancer cells in newly diagnosed men? hence, eventually replacing external radiation therapies?
Newly diagnosed METASTATIC men. I don't understand why you won't answer the question - radiation to WHAT exactly? I have no idea what you are asking because you refuse to clarify your question.
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