PHASE 3 ECLIPSE STUDY FOR (MCRPC) PATIENTS- FIRST INFUSION OF Lutetium- 177

[john4803]

Just had my 1st infusion of Lutetium- 177, 3/9/23, in the Eclipse Trial.

Received 216.0 mCi of Lutetium- 177, after receiving ondansetron (Zofran) (for possible nausea) & 0.9% Saline Solution. Continued the Saline Solution for 1 hr. after infusion, also.

The Technician said the LU 177 was manufactured in Finland.

So far no side effects. No dry mouth, nausea, tiredness, etc. Knock on Wood! 😀

See Bio for more details, but basically, after 6 months of Apalutamide & Lupron, PSA went from 0.1 (after falling from 7.3) to 0.6. Following PSMA PET scan it was obvious I was MCRPC.

MO recommended me for Eclipse Trial, started at St. Louis U's "Center of Excellence in Radiopharmaceutical Therapy" & was accepted. Went from PSA of 1.1, at Eclipse screening lab work to 2.0 yesterday. Received the "long straw" & was immediately placed on the study drug vs. SOC.

Will receive 2nd infusion in 6 weeks. Will keep Bio up to date on progress.

[RyderLake2]

Hello,

Is the ECLIPSE trial for men who are castrate resistant who have never had chemotherapy? If so, there are a lot of clinical trials going on right now that are looking to have Lutetium-177 (Pluvicto) given much earlier in your treatment plan than currently approved by the FDA and Health Canada. I am currently participating in the world-wide SPLASH trial which sounds as if it has a very similar objective to ECLIPSE. Not quite sure what the difference is.

[john4803 in reply to RyderLake2]

Yes, it is for castrate resistance & it is comparing SOC, ie., Xtandi & Zytiga vs. LU177.

[RyderLake2 in reply to john4803]

...pre-chemotherapy? If so your trial has exactly the same objective(s) as the SPLASH clinical trial that I am on. The Germans, Australians, British and most of the world for that matter use Pluvicto (Lutetium-177) to treat prostate cancer much earlier than what it is currently approved for in North America. Good luck!

[john4803 in reply to RyderLake2]

This is strange because SLU has been participating in the Splash trial, also.

[Mw921000000 in reply to john4803]

hey John! I hope this trial brings you great results. One question—- you haven’t had chemo right? I’m trying to see what’s available for my dad who’s castrate resistant other than chemotherapy.

[john4803 in reply to Mw921000000]

Correct, I have not had Chemo! My MO told me Chemo only lasts 8-12 months, typically and LU177 is better. So, he recommended me for it, instead.

Dr. Kwon (Mayo), says in a Youtube video that the rule has wiggle room and that you don't actually have to fail Chemo but at least try it, even for a short period.

It probably all depends on the health care system or insurance company's interpretation, however?

[Wilson_123 in reply to john4803]

How long does LU-177 last ?

[john4803 in reply to Wilson_123]

Good question, Wilson? I can't seem to find a definitive answer? My MO thinks it lasts longer than Chemo because he recommended me for the trial but he does not have experience with it himself. The Vision trial is not very reliable according to my trial Doc. because they were pretty sick participants.

[Hidden in reply to RyderLake2]

the. British are hardly using Lu177 at all

My husband had first infusion yesterday

We have to pay for it private

No plans for it being on NHS it was just refused by NICE

there are very few places you can even pay for it and only being given after two forms of chemo

Bit of a last resort here

My husband has been very sick overnight. Not easy as we are in a hotel

I am hopeful for something positive but he has widespread disease

Recent developments ptosis of one eye - mets in skull and lymphoedema

It is pretty hard

His body is basically deformed in so many ways

A strong handsome fun man has been diminished by this awful disease which is underestimated by the world

When I read this site I am struck that all you poor chaps go through a gamut of the same treatments

It isn’t good enough

Too much late diagnosis and no real progress because people with aggressive disease events die from it and it isn’t nice to watch and feel so helpless

Sorry this isn’t the upbeat stuff normally posted but it is reality

Sue

[Hidden in reply to Hidden]

that should be British not rotessier

[john4803 in reply to Hidden]

It is truly a scary time for you as you struggle with this "plague-like" disease. Our hearts go out to you and your husband!

My care team, in the Eclipse Trial told me only trials are getting LU177 reasonably soon in the US. They are not taking on any new patients (having failed Chemo), at this time. I consider myself extremely lucky to have qualified for this study when I did!

I failed to have my PSA tested when I should have, due too a time when the test was discouraged by Docs. and Insurance companies (early 2000's). As a result, it had left the Prostate and now I will battle it for life. Unless they come up with immunotherapy, I guess?

Hopefully, he can hang on until they come up with the "magic bullet"?

[Hidden in reply to john4803]

how kind of you to come back to me

I wish you the best

Happily we are on the train on our way home

Best wishes Sue

[RyderLake2]

Hello,

Ask your clinical trial team what the difference is between the SPLASH and ECLIPSE trials. If you get an answer let me know.

[Fightinghard in reply to RyderLake2]

Ryder - basically it is the same trial. Being run separately by two different drug companies that can make the LU.

Point Pharmaceutical is funding Splash and Curium Pharmaceutical is funding Eclipse.

[john4803 in reply to Fightinghard]

Thanks, for the info. I am waiting on my care team to respond on this, since they are hosting both trials.

[RyderLake2 in reply to Fightinghard]

Thanks for that information. So same trial, different drug companies. I thought Novartis had the exclusive rights to market Lutetium in North America but obviously there are other drug companies wanting to get in the mix. We can only hope that both trials have similar outcomes that will lead to Pluvicto (Lutetium-177) being approved for men much earlier in their treatment plan and pre-chemotherapy..

[Fightinghard in reply to RyderLake2]

rydar

I was in the Splash trial last fall. Excellent results from dose 1, then dose 2 was positive but not great. Dose 3 gave me bad reaction of very severe bone pain, then mo did a new scan and found progression. So I was moved out of the trial and on to SOC chemo.

Wishing all the LU patients a great result and long long remission

[Ollie1948 in reply to Fightinghard]

did your PSA go up during trial?

[Fightinghard in reply to Ollie1948]

Ollie and john

during the splash trial per their rules, they did not share psa with me or even my mo. However before dose 1 it was mid 30s. After dose 3 and trial ended early for me due to progression on scan it was 72

I decided not to put up much bio because of a stalker on the site that was using the info to try and start arguments

Good luck with your trials. I was told by my trial coordinator that of the 20 enrolled locally, she had seen really good response in 5, mixed results in 9, and 6 including me that had to leave the trial either because of negative side effects or progression during the trial.

God bless and stay strong

[john4803 in reply to Fightinghard]

Sorry to hear of your struggles! What were your PSA's? Didn't see anything on your Bio?

[TeleGuy in reply to RyderLake2]

Don't confuse lutetium (the radioisotope), which is made all over the place, with the radioligand used to treat prostate cancer. Novartis has rights to the lutetium-labeled PSMA-617 ligand, making 177Lu-PSMA-617. The SPLASH and ECLIPSE trials are using a different ligand, PSMA-I&T. They use 177Lu-PSMA-PNT2002 and 177Lu-PSMA-I&T, respectively. My understanding is that I&T and PNT2002 are the same but named differently for some unknown reason.

[john4803 in reply to TeleGuy]

The Eclipse Trial uses only 4 infusions. Not sure about the Splash. But I think with Pluvicto there are 6. Could this be a difference, too? Thanks, for the detail, however!

[RyderLake2 in reply to john4803]

Hello,

The SPLASH trial also has four cycles of Lutetium-177 PNT2002 approximately eight weeks apart.

[Ollie1948 in reply to john4803]

Splash trial has 4 infusion 8 weeks apart

[john4803 in reply to Ollie1948]

The Eclipse trial spaces infusions 6 wks. apart.

[RyderLake2 in reply to TeleGuy]

That makes a whole lot of sense. Thanks for clearing up my confusion. I did not make the distinction in my head between the radioisotope and the ligand. I was wondering how Novartis got exclusivity in North America to a drug (Lutetium-177) which is in use world-wide.

[john4803]

I will but could it be the Met. load? My PSA was only 1.1 going in & I had to have at least 2 new Mets. to qualify.

[Biobro]

So they're starting dosing again with LU 177! Great news. Quick question: the tech said the LU 177 was manufactured in Finland. My understanding is that the recent manufacturing problem has been with the targeting molecule (which is proprietary to Novartis) not with the LU 177 (radioactive substance) which is manufactured in many places. Do you know if the tech was referring to the targeting molecule or the the LU 177?

[john4803 in reply to Biobro]

No, sorry, but she just looked at the small "coffee-shaped" can it came in and read the info. on it saying, "made in Finland". Don't know anymore than that. Will ask at my next visit. Sorry!

See my note on SLU is not taking anymore patients for LU177, except for trials, at this time.

[Fightinghard in reply to john4803]

the LU177 has been approved by the FDA for post-chemo patients. Many cancer centers in the US are using it when medication supply is available.

[john4803 in reply to Fightinghard]

Yes, I realize that but there seems the demand is outstripping supply now. The Eclipse Trial is to try to get FDA approval for it's use before Chemo!

[Hidden]

Hi John:

Please keep us updated. I am starting lulu 177 April 7th. very curious about your side effects and how it is going. Thanks Tom

[john4803 in reply to Hidden]

I will be sure to update everyone, including my BIO!

[cfrees1]

I had my 2nd treatment for the Eclipse Trial today. Interesting that you got saline for an hour afterwards, I didn't get that but really didn't want to sit there for another hour. My PSA 1 month after my first treatment was 0.02, down from 21 something. I was super happy with that.

[john4803]

That sounds fantastic! Your Bio doesn't show your recurrence? If you don't mind, what were you on?

Also, as I posted I am doing Eclipse in St. Louis. I live just West of St. Louis. Where are you doing yours, if you don't mind?

[cfrees1 in reply to john4803]

is this question meant for me? I’m doing Eclipse at the University of MInnesota. I’m not sure I understand your other questions.

[john4803 in reply to cfrees1]

So, I guess I was wondering if you were just on Lupron prior to getting into the study? And you got the LU177 right away without doing SOC?

[cfrees1 in reply to john4803]

No, I have followed SOC for the last 7 years, including ADT, surgery, and radiation. The only thing left at this point was chemo. This study allowed me to do Lu177 before doing chemo.

[john4803 in reply to cfrees1]

Yes, exactly the same for me except I only made it 5.5 yrs. Best of luck & keep us posted.

[j-o-h-n]

Way to go johnny O............

Good Luck, Good Health and Good Humor.

j-o-h-n Saturday 03/11/2023 7:36 PM EST

[john4803 in reply to j-o-h-n]

Thanks, j-o-h-n!