Clinical Trial using 177LU-PNT2002

[Joeym1040]

I an applying for the Phase III clinical trial using 177LU-PNT2002. Anyone have any experience with this agent?

[Tall_Allen]

AKA 177Lu-I&T

[Joeym1040 in reply to Tall_Allen]

Thanks....just got it!

[joeguy]

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

[Joeym1040 in reply to joeguy]

i just passed initial screening at Moffitt in Tampa Fl.. Waiting for dates for tests and scans. Good luck to you.

Joe

[joeguy in reply to Joeym1040]

good luck to you too..... are you in the splash trial?

[Joeym1040 in reply to joeguy]

Thast's whay i am applying for.

[joeguy in reply to Joeym1040]

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.

[Joeym1040 in reply to joeguy]

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.

Joey40

[joeguy in reply to Joeym1040]

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.

[Joeym1040 in reply to joeguy]

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.

Joey40

[joeguy in reply to Joeym1040]

Best of luck to you too

[Manilo in reply to joeguy]

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

[joeguy in reply to Manilo]

why only one dose of LU177? Did you have side effects?

[Manilo in reply to joeguy]

I had one infusion of Lu177 with Dr Baum in July 2021, and expected a 2nd in Jan 2022, but Dr Baum never answered me since January.

[tango65]

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.

ncbi.nlm.nih.gov/pmc/articl...

[Joeym1040 in reply to tango65]

thank you Tango65!

[tango65 in reply to Joeym1040]

Best of luck with the treatment.

[TeleGuy in reply to 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.

[Joeym1040 in reply to tango65]

My understanding is it is also less radiation which would be a good thing for me.

[cesces]

What advantages cause you to choose this treatment?

[Joeym1040 in reply to cesces]

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.

Joey40

[cesanon in reply to Joeym1040]

"Novartis Pluvicto™ approved by FDA as first targeted radioligand therapy for treatment of progressive, PSMA positive metastatic castration-resistant prostate cancer

Mar 23, 2022"

[Joeym1040 in reply to cesanon]

But i believe you must also have undegone chemotherapy treatment.

[Joeym1040 in reply to cesanon]

You are correct. My error.

[Joeym1040 in reply to cesces]

I believe i mis-spoked! You can be castrate resistant but you must have also undergone chemothereapy. Sorry for the misinformation.

Joey40

[spencoid2]

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.

[Bobcat64 in reply to spencoid2]

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.

[Joeym1040 in reply to Bobcat64]

Will do. Hope we both make it in.

I will stsy in touch.

Joey40

[spencoid2 in reply to Bobcat64]

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.

[Bobcat64 in reply to spencoid2]

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.

[spencoid2 in reply to Bobcat64]

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.

clinicaltrials.gov/ct2/show...

[Bobcat64 in reply to spencoid2]

where are you having your test done? You are correct srr

[spencoid2 in reply to Bobcat64]

recruting starts Oct 3. the trial is at UCSF San Francisco. I assume they will do the PSMA scan. I think I had one a while ago but they probably want something current to be sure the PC is expressing PSMA.

[Joeym1040 in reply to spencoid2]

You will know if you are in the control are because you will not receive any treatment except the aberaterone.

[spencoid2 in reply to Joeym1040]

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?

[CAMPSOUPS in reply to spencoid2]

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.

[spencoid2 in reply to CAMPSOUPS]

my insurance covers all that but i understand that others might not be similarly covered

[Joeym1040 in reply to CAMPSOUPS]

The main reason is that if your disease starts to progress while you are in the control arm, you can be transfered over the the Active Arm and receive the 177Lu-PNT2002.

[CAMPSOUPS in reply to Joeym1040]

Nice.

[Seasid in reply to spencoid2]

Can you ask for Enzalutamide? I wouldn't drop out.

[Joeym1040 in reply to Seasid]

Yes the info i have says enzalutamide or abiraterone.

[alohapickle in reply to spencoid2]

I believe that subjects are randomized but they are not blinded. You will know what arm you are in.

[spencoid2 in reply to alohapickle]

this study is not blinded. my UCSF oncologist said it is not nice to join a study and quit if you get in the control arm. for that reason people in the control arm might be able to move to the active arm if their disease progresses. however the wording does not make it clear when or why this would happen. Dr Agarwall said that they have to word it that way for legal reasons. Initially they did not have the option listed and they could not keep people in the control arm so they added the option. For me, I am starting chemo so I do not need to worry about this study. I can get on LU 177 standard treatment after chemo or if i can not tolerate it.

[Joeym1040 in reply to alohapickle]

that is correct

[Joeym1040 in reply to spencoid2]

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.

Joey40

[spencoid2 in reply to Joeym1040]

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

[Seasid in reply to spencoid2]

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.

[Joeym1040 in reply to Seasid]

That is it exactly. Control arm is probably a better option as long as Xtandi or Zytega are working.

[Seasid in reply to Joeym1040]

we still need to know the exact contract. Otherwise we don't really know... Am i correct?

[Joeym1040 in reply to Seasid]

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.

[Seasid in reply to Joeym1040]

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?

[spencoid2]

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

[Joeym1040 in reply to spencoid2]

im trying to delay chemo as long as possible.

[spencoid2 in reply to Joeym1040]

same here. that is why i am waiting for the trial that does not require chemo first.

[spencoid2 in reply to spencoid2]

that is now castrate resistant not not

[Charles4212]

have a consolation at Cornell Presbyterian in NYC on October6. Please stay in touch Thanks Charles 4212

[Joeym1040 in reply to Charles4212]

will do