Hello all, For the last eight or nine years I have participated in this forum dispensing what little information I could to various participants. After nine years and four months on Zoladex (goserelin) and the last five years on Xtandi (enzalutamide) plus Zoladex my PSA has started to slowly climb. It is still very low (2.6) but my oncologist wants to move to the next stage before my PSA gets much higher. With his help, I have recently been offered a spot on the SPLASH clinical trial involving Lutetium/PNT 2002 PSMA therapy . No previous requirement for chemotherapy. Two thirds of the participants get the LU-177 and one third get the best SOC. In my case, this would mean coming off Xtandi and going onto Zytiga (abiraterone). Health Canada has not approved the use of Lutetium 177-PNT2002 for metastatic prostate cancer but has allowed its use in this study. Supposedly, approximately 390 participants will take part in this study with roughly 10 from my part of the country. Any advice from members who might know of, or be participants in, this trial? Also what is the difference between the sponsor of this trial POINT BioPharma and Novartis the makers of Pluvicto (Lutetium-177)?
My Turn to Ask a Question: Hello all... - Advanced Prostate...
My Turn to Ask a Question
I Am sorry about this uptick ,RyderLake2! ….but ,by all standards 1 4 yrs before castrate resistance is dammed good .Although , I’m sure thats not what you want to hear? I’ve followed you for years . I’ve been under the radar myself for over 7 yrs.. I recon that it’s just the Eye of the storm for me .. Good luck in this round Sir! 🍀🙏
Thank you so much Lulu,
It has actually been nine years and four months since diagnosis (the end of May 2013) with many twists and turns along the way. I have always tried to help people battle this damn disease by providing what little help I could but now I need a little help myself. A four leaf clover and prayers, it doesn't get much better than that!😊
Just two years before my dx . I had pc in me for years my uro said ….Compassion is what separates us from wild hyenas ... Prayer works in different way . We’ve got to stick together in this mud.. ❤️🍀🙏
I've thought about that. I might have got some freeby, freeby extra time on mother earth walking around unknowingly with my PC for a few years before diagnosis. I've thought about adding that estimated time to my time after diagnosis. Gives me more years alive with this to celebrate lol.
For what its worth I think your next therapy would be chemo, and not another 2nd line hormonal? Something to ask about.
Hello,
The Zytiga (abiraterone) is the SOC arm. What I am hoping to get is the Lutetium which is a PSMA directed radioligand therapy. It has been on my radar for a number of years and what I like about this trial is participants on the Lutetium arm receive it prior to chemotherapy. That gives me one additional step.
I understand but if you get randomized into zytiga you then are doing two 2nd line hormonals in a row. Everything I have read on this board indicates its better to do chemo in between 2nd line hormonals. That is what I was trying to point out.
But i do hope you get into the arm you want to be in and it wipes out as many of the critters as possible.
but if you do get on the SOC arm you can always quit. that is what i plan to do. there is a similar trial in California that doesn't require chemo. if i get on the SOC arm my plan is t start chemo so i can then qualify for LU 177. i don't know about the study you mention in Canada but the one that i am after uses a different ligand than puvicto (Lutetium-177-PSMA-I&T)and it is suggested that being a smaller molecule it can reach more cancer cells? I think (?) that Lutetium 177-PNT2002 might be the same
but it appears this study has crossover so he wouldn’t need to quit. I saw this in the link TA provided.
the study i am looking forward to also has crossover but it says "may be eligible" or something like that, it is not definite.
When I read crossover descriptions with “may be eligible”, I interpret that literally: “may” means “you have permission”. While, if it was “might be eligible”, that sounds like “it depends on …x, y, z”.
I’ve been meaning to ask my MO about this, but I’d think she’d say “it depends on the trial” … sigh. So, when I have to cross over that bridge (get it?), I’ll ask the trial contacts upfront.
let us know what you find out. i asked the study contact person and she was as vague as the description. something like "may choose to" would be a lot better. does anyone speak English aymore?
Hello,
That is one of the big reasons that attracted me to this trial. Also I was told by the Cancer Agency that this study was limited to only 390 participants with only 10 from the province I live in. If that is the case, I am very, very grateful. I still don't know which arm I am in but hope to find out in the next few days.
Hi Spencoid2,
I think you are right Lutetium-177 PSMA I and T and Lutetium 177 PNT2002 are one and the same. Perhaps one of our knowledgeable contributors can correct us if we are wrong.
Though you might be interested in this:
urotoday.com/video-lectures...
Thanks so much Tall Allen,
This is EXACTLY what I was looking for. I was hoping you could pull something up from your extensive library of resources.
ryder
I am in the Splash trial. Just took 2nd round of 4 LU shots. Very well tolerated for me. Only side effect has been fatigue that starts right after injection and lasts about 7 days. After 7 days I feel great
I am in the SPLASH trial in Dallas. Have scans lined up in a couple weeks, and I should be randomized after that. Like Ryder, I am hoping to be in the LU177 arm, but will do the Zytiga arm if I get unlucky. My PSA doubling time has accelerated to about 3 weeks now, so I am anxious to get started. Just curious, but what was your PSA at when you started the trial? I have heard that the more of a cancer load you have at the time of infusion, the less likely the LU177 will affect things like the saliva glands.
Thanks so much,
Thee of several things that attracted me to this trial are: One It is randomized not blind so you know whether you are getting the Lutetium or not. Two The randomization is two to one with 2/3 getting the Lutetium. I like those odds. Finally Three If you are on the Zytiga (abiraterone)/Xtandi (enzalutamide) or SOC arm they will switch you to the Lutetium arm if the comparison treatment starts to fail. I like that as well. As for my PSA, it is currently at 2.6. My oncologist (who tends to be very conservative) wanted to make a move as soon as it topped 2.0. He watches me like a hawk with monthly PSA tests. As an example, I have had over one hundred PSA and testosterone blood tests since diagnosis nine years and four months ago.
my PSA was doubling in about 4 weeks. Last number I saw was 22. During the trial, they do not share the psa, even with your MO. Dont understand why…. But the LU is making me feel better at least.
Very minor dry mouth for a couple days after each injection but seems to resolve itself. Still have 2 more rounds to complete ahead of me. Hope no serious side effects show up
good to hear that your side effects have been mild. From what I’ve heard the fatigue and dry mouth are the most common. They claim it doesn’t happen often, but apparently if we are very unlucky, it can give you permanent dry mouth.
Hello,
Good to hear. This is the kind of information I need. I am well acquainted with fatigue after five years on Xtandi. As I tell my drinking buddies "happy hour" these days is a nap. 😊
hey Rider
I was on xtandi for almost 2 years. The LU fatigue is worse (for me anyway) for the first few days. After about 7 days I feel better than I have for a long time.
Hi Fightinghard,
I think we should stay in touch. I was told only 390 participants on this trial world-wide. If true, and those on the trial are randomized 2/3 (Arm A-260) to 1/3 (Arm B-130) then there is not a lot of us out there. I am totally familiar with the fatigue brought on by five years on Xtandi (enzalutamide). Fingers crossed I am on the Lutetium arm. I should find out in a few days which arm they are going to place me on. BTW, I like the acronym SPLASH.
Fightinghard,
I have a couple of questions for you. How are you getting around the safety requirement to stay at least seven feet away from others for the three days after treatment? How about avoiding prolonged car trips with others? Also avoiding using mass transit (bus, train, etc)? Are you sleeping alone in a separate bed seven feet away from others? I have been told all these requirements are for the three days after treatment. I know these instructions are to limit radiation exposure to others. However it might mean I have to move into the basement bedroom. Already I am starting to feel like a potential "lab rat" that glows in the dark!😊
ryder
I try to be extra cautious to protect family
I stay at a hotel for first 2 nights then sleep in spare bedroom for 7 days. Use seperate bathroom too. Throw away underwear for first 3 days. Urine has highest concentration. Stay 6’ away for first 4 days around the house. Keep all dirty clothes in bag out in garage far away from everyone for 10 days before laundering all of them separately from others clothes
Yes it might be extreem but makes me feel better
Good luck with your LU
I hope I have the good luck on Xtandi that you have had. Going on four years , so far. Im looking forward to you getting that Luteum 177 pnt 2002 or similar , that’s it works a good long time for you ….so we all can look towards something that might bring us along further as well. Crossing my fingers and sending out positive vibes( order of merit board ) for you too. Can’t hurt.
❤️❤️❤️
Thanks so much Kaliber,
I have followed you for many years!
❤️❤️❤️
You, brother Kal and others here with high PSA at dx have been on my radar here on the forum since my first days poking around here. My high PSA, volume of PC caused me to seek out you guys. Keep on doing well!
Thanks so much,
Not sure I should be on the same level as Nalakrats and others (or even close) but I have had a hell of a run. Nine years and four months with metastatic prostate cancer that had spread extensively to my bones (from my knees to my neck) before initial diagnosis. In our town, I am recognized as the "poster boy" for advanced PCa. I have counselled a lot of men over the nine plus years, unfortunately many of whom have passed away. Damn! However, I knew some day it would come to an end. I am just hoping this clinical trial buys me a little more time. It does provide one extra step between Xtandi (enzalutamide) and chemotherapy (docetaxol). When I found out there were only 390 men enrolled in this trial world-wide and only ten spots offered to men in my province I am extraordinarily grateful. Thanks again for your support!
Excellent for you it seems this trial.
I too had and now progressing so still have to some degree mets from skull to shins.
Zytiga efficiency wore off about a month ago and I am in preliminary approval process for the Dora trial.
I need chemo again (had chemo at dx 3 years ago) to tamp down my extensive mets and hopefully resensitize my PC cells so that Xtandi or other treatment may work. The trial is chemo and possibly Ra-223 which would be beneficial to my bone mets. Unblinded trial so I will know if I get the Ra-223 with the chemo.
kaliber
4 years on xtandi is very good. Hang in there my friend
❤️
Hey Ryder,
I have just started the SPLASH trial in Dallas. Im in Oklahoma so its a bit of a commute for treatment. Like you, I am hoping I get into the LU177 arm of the trial. I have scans lined up on the 19th and 20th, so I should find out which arm Im in sometime after that. I have agreed to do the Zytiga arm of the trial if I get unlucky, mostly because its about the last hormonal drug I havent already tried. The doctor leading the trial tells me that once you fail one of the next gen hormonals (in my case currently failing Darolutimide with Orgovyx), there is only about a 10% chance one of the others will work, so it may be a short run on Zytiga.....
Hi Joe,
I think we should stay in touch. You are one of the few people who has responded who is potentially on this trial. I have been told I will find out in the next few days which arm I will be on. I suppose if I am scheduled for a PET scan then I will know for sure that I am on the Lutetium arm. I don't think the Cancer Agency is not going to waste their money giving me a PET scan if all they are going to do is switch me from Xtandi (enzalutamide) to Zytiga (abiraterone). I should know more by this time next week.
I agree, we should keep each other posted. They are requiring 3 different scans for me coming up on the 18th and 19th of Oct. Looks like Im doing a PSMA scan on the 18th, then they will do a CT with contrast dye, and some sort of PET on the 19th. I am told I will be "randomized" shortly after the scans and will be told which arm I am in at that point. Im not sure how they do this randomizing, but I hope its a big wheel I get to spin and see what it lands on !
Hi Joe,
As stated before, they are not going to give you all those scans to put you on Arm B so you must be going onto Arm A (the Lutetium Arm) unless of course you are not PSMA avid. Good luck and stay in touch.
rider
They gave me all the scans prior to randomization. The scans provide them with PSMA avidity plus a baseline to measure against
my husband got all the scans and then was told what arm. He ended up on control arm. The scans are for what fightinghard mentions below. Now that he is in trial he is getting scans every 3 month.
You are correct. As you know, THERANOSTICS is a personalized approach that brings together THERApy and diagNOSTICS. Since your PCa must be confirmed to be prostate specific membrane antigen (PSMA) positive (and only about 80% of prostate cancer is PSMA positive), obviously your diagnosis has to come before your therapy. A positive PSMA scan confirms the presence of PSMA. I was told at our initial briefing at the Cancer Agency that they would be in touch with us in 2-3 weeks. Well we are over two weeks since that meeting and next week we hit three so I think we will be called imminently. Good luck getting the drug company pay for your trial!
Hi Joe,
I have a couple of questions for you. You indicated that you live in Oklahoma and you are getting your treatments in Dallas. Making the assumption you can't drive yourself and a family member has to drive you back to Oklahoma then how do you get around the safety requirement to stay at least 7 feet away from others for the three days after treatment? I also remember being told to avoid prolonged car trips with others and to avoid using mass transit (bus, train, etc.) on trips that are 4 hours or longer. The last two requirements are also for the three days after treatment and are designed to limit radiation exposure. Thanks for your reply and stay in touch.
I have heard that the warnings about radiation exposure after treatment are a little over blown and they primarily only apply to pregnant women and infants . My wife will be traveling with me, so if they think there is a risk being in the car together, I guess we can stay an extra day or two in the hotel before driving home.
looks like a great opportunity for you to get Lu-PSMA treatment as you have developed castrate resistance. Presume tha if you are in the 1/3 on placebo you will be offered the treatment when they unblind it. In the meantime the switch to abiraterone makes sense now anyway with enzalutamide failing. I would go for it.
Thanks Mateo,
I am going to go for it although I have yet to find out which arm I am going to be on. This is not a blind trial but a randomized trial so I will know from the get-go whether I am getting the Lutetium-PSMA treatment or not. If I am on Arm B, and if I am eligible as determined by my study doctor, my treatment with Zytiga (abiraterone) will end and my treatment may be switched to Lutetium-177 PNT2002 (Arm A). This crossover option allows me to start a new Cycle 1, Visit 1 and continue for four cycles. As mentioned before this trial does not require prior chemotherapy which I can look at if I am not PSMA avid.
hi…my husband started the splash trial in Aug. We are in Philadelphia area. He got the control arm and was switched from abiraterone to Xtandi. We were happy he got in but not so happy he got the control arm. However, he seems to be doing really well (pending upcoming scans and blood work) on Xtandi. Problem for us is that this trial is now costing us
a lot more money. The out of pocket cost of Xtandi will be approx $11,000 next year vs a much much lower cost for zytiga. Before opting for trial we were given 3 options with the understanding neither was better then the other and he would eventually hit all 3. We chose the trial because of the hope to get on LU177 and the availability of crossover. However we did not expect the trial to be such a large monetary burden. Abiterone was much cheaper. So he may drop out pending a response from clinical trial folks. His concern now is what is this trial doing for him other then increased # of scans which he is not crazy about.
Hello,
I am really amazed that by volunteering for a clinical trial it is costing you money. That doesn’t seem quite right to me. I pay nothing for my participation in the SPLASH trial and even get $70 to offset travel expenses every time I drive to the Cancer Agency site to receive treatment. At least that is what I have been told. I haven’t started treatment yet nor have I found out which arm I am in. I should find out next week. If I am placed in the non-Lutetium arm I will be switching from Xtandi (enzalutamide) to Zytiga (abiraterone). Good luck!
hi..yes if you get the control arm, that is not covered by trial rather insurance. Unfortunately he went from a zytiga to Xtandi per trial rules. But no one explained the monetary impact of that if you are on Medicare. I raised this issue with trial folks and they were “surprised”. Apparently they are looking into. Seems to me these drug companies should cover cost if participants are forced to use their drug. There should be no financial burden placed on participants.
Not what you're looking for?
You may also like...
Is there hope? I’m dreading asking the question of “how long”…
What life extending questions would you ask the top oncologist. If you were me.
Questions to ask Oncologist at first appt to review scans/talk treatment
Ask for advice on my progress, mCRPC Cabazitaxel
My Second Lutetium-177 Treatment in New Delhi
In need of advise for my father
Questions about medicare/insurance - turning 65
Can anyone answer my question?
After Xtandi, 177Lu-PSMA-617 or BAT?
Asking for my dad!!
