I an applying for the Phase III clinical trial using 177LU-PNT2002. Anyone have any experience with this agent?
Clinical Trial using 177LU-PNT2002 - Advanced Prostate...
Im about to have experience with it. After a 1 1/2 yrs trying to get into a trial for LU177, I am heading to Dallas in 2 weeks for initial appointment with oncologists for a trial at UT Southwestern using 177Lu-PNT2002
i just passed initial screening at Moffitt in Tampa Fl.. Waiting for dates for tests and scans. Good luck to you.
good luck to you too..... are you in the splash trial?
Thast's whay i am applying for.
me too........ I would think the list of castrate resistant, metastatic guys that have only had ADT and no chemo would not be very large.
Like me probably recently diagnosed. MO tried to get me into Pluvicto treatment but i did not qualify. I guess he was going to suggest chemo at our next meeting but i found this trial. He agrees i should try to get qualified.
I was actually metastatic in 2016 when I had my RP surgery, but it appeared to be only pelvic lymph nodes (those dont count as metastatic for some silly reason). My PSA after surgery was still at 11.00. It wasnt until I had a PSMA scan a couple years ago that more distant lymph nodes were confirmed. ...... I guess 6 years is a pretty good run to have only been on ADT. Very hopeful about the 177Lu treatment. I will be disappointed if I get put into the trial arm that receives Zytiga.
If you get put into the control arm (no treatment except Zytega, or Xtande) and you disease progress you can be switched to the active arm and received treatment. If you disease does not progress during the trial that is good news. And hopefully the drug will be approved shortly after the end of the trial. Best of luck to you.
hey that is my case now. Though I had 1 cycle of Lu177 a year ago.
But only have been in ADT until now. And SBRT to a rib.
Now CRPC looking at what to do next, in following weeks
I had treatment with this agent in 2016 in Munich at the Technical University. It was very effective .
The ligand of Lu 177 PMSA I&T is smaller than the ligand of Pluvicto and it offers the theoretical advantage of a better penetration into the cancer cells. It seems that overall survival is not different than Pluvicto.
thank you Tango65!
I likewise did 5 treatments in Munich and got 16 months of undetectable PSA out of it and 33 months from beginning of that adventure to my next (started chemo this week). I would be curious to know if anyone has any insight into the I&T ligand. I think that it's not patented or not patentable at least in Europe so people are free to use it, and it might be competition for the $45,000 a dose pricing they are doing for the PSMA617 ligand.
What advantages cause you to choose this treatment?
It is very simalar the Pluvicto which was approved by the FDA but only for those who are still hormonse sensitive. It appeears to be a very effective treatment and will prolong having to go to chemo. The trial uses a different agent which i understand is less radiation then Plubicto and is open to men who are castrate resistant.
"Novartis Pluvicto™ approved by FDA as first targeted radioligand therapy for treatment of progressive, PSMA positive metastatic castration-resistant prostate cancer
Mar 23, 2022"
I am signed up for being recruited in the trial at UCSF that supposedly starts on Oct 3. I had not noticed that it was the "better" ligand(Lu-I&T, called Lu-177-PSMA-I&T in this trial) until I was prompted to look at the trial information. clinicaltrials.gov/ct2/show... For those who are crMPC and who have not had chemo this is a unique study. 400 or so participants so it probably will be open for a while. One of a few requirements is previous treatment with next-generation androgen receptor (AR)-directed therapy (e.g. abiraterone, enzalutamide, apalutamide, darolutamide). It is a blind study 2 to one active vs control arm but I intend to drop out if I am in the control. Do not want to spend hours driving many hours to not get treatment. I am on aberaterone and prednisone already. If I do get in the control arm I will be looking elsewhere or just doing chemo so I qualify for regular LU177 treatment not in a trial.
I’m in the same position as you going initial counsel in 2 weeks. If I don’t get in the Lu177 arm I plan on going to Germany for treatment or start chemo please stay in touch.
My MO said he could do one infusion and stop it due to bad reaction. Surprised he would be willing to misrepresent the situation so I guess he thinks I really should do LU 177.
How will you know that you are on the control arm? I have a Geiger counter which should let me know. The details of the study I posted say that people in the control arm "may" be switched to the active arm if they show progression. I hope to get clarification on this but still probably will high tail it if I do get on the control arm.
My understanding is the control arm will get LU177 and all others will get Xtandi or Zytiga which are Pill form. If you progress on the pills you can graduate to LU 177.
this is from the trial i am hoping for
Participants will be randomized on a 2:1 basis to receive Lu177-PSMA (Investigational Arm) or standard of care hormone therapy (Control Arm). The Control Arm will consist of treatment with either abiraterone with prednisone or enzalutamide depending on the clinical judgement of the investigator. Participants who are randomized to the control arm who demonstrate radiographic progression may be eligible to crossover to receive Lu177-PSMA. Somewhere i read that those who progress on SOC "may" switch to the active arm but i can not find that now.
where are you having your test done? You are correct srr
You will know if you are in the control are because you will not receive any treatment except the aberaterone.
I had not read the new version of the posting carefully. Originally it said blinded which I thought was strange but it did. I was wondering if they gave you a placebo infusion and gave SOC to everyone. Now they no longer say blinded. Not sure why anyone would stay in the study to not get any treatment unless they could not afford SOC and wanted that?
Not sure why anyone would stay in the study to not get any treatment unless they could not afford SOC and wanted that?
I'll play devils advocate my 2 cents is normally as a participant in a trial you get a full and frequent complement of scans and labs. And not always but often full array of genetic mutational test, ctc's. etc. A look at all the AR's, PDK, etc., etc.
my insurance covers all that but i understand that others might not be similarly covered
Exactly and another advantage is that if you are in the control arm and your condition starts to worsen you can be moved over the the active arm. Good luck to you.
unfortunately it says may be eligible not can even can would imply uncertainty. it is not as if you can expect to be moved. i wrote to the study coordinator for clarification.
Participants who are randomized to the control arm who demonstrate radiographic progression may be eligible to crossover to receive Lu177-PSMA
I agree with you. It should be more clear. Better to sign a contract which is clear so you can get benefit if standard of care fails.
Maybe than getting into the control arm would be more beneficial for you. Maybe you can have a good run on the standard of care alone without a need to radiate yourself to death six times.
That is it exactly. Control arm is probably a better option as long as Xtandi or Zytega are working.
we still need to know the exact contract. Otherwise we don't really know... Am i correct?
I have a copy of the contract. "If you are in Arm B and you are eligible as determned by your study doctor, your study treatment with abiraterone or inzalutamide will end and your study treatment may be switched to177Lu-PNT2002 (Arm A) starting a new Cycle 1, Visit 1 and continuing for 4 cycles.
To determine if you are eligible to cross over from Arm B to Arm A, the following procedured will be performed at the Crossover Visit, only if it has been more than 30 days since the Progression visit."
Goes on to ask a bunch of questions and blood tests and scans.
Does not say what passes and what fails. Just says your Study Doctor will determine if you are eligible.
oh well, like every contract written, they can do everything what they want.
Do they have a discretion to put you into the clinical trial if you don't satisfy one of the inclusion or exclusion criteria? Maybe to ask the chief investigator of the trial to grant you an exemption?
What do you think?
I have had SOC for over a year and am not castrate resistant. i doubt that any more time on SOC would help unless it was a different drug. I am castrated and on aberaterone. if i were on the control arm with enzalutamide that might be better but my MO is suggesting chemo or immune therapy not just switching next-generation androgen receptor (AR)-directed therapies
im trying to delay chemo as long as possible.
have a consolation at Cornell Presbyterian in NYC on October6. Please stay in touch Thanks Charles 4212