LU 177 and ACT 225 - Trip to Germany ... - Advanced Prostate...

Advanced Prostate Cancer

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LU 177 and ACT 225 - Trip to Germany looking likely

WhiteStrat profile image
46 Replies

Looking for the latest updates on LU 177, ACT 225, and anything else I should consider. After reviewing numerous posts on this topic, I am leaning toward Dr. Ezziddin in Homburg or Dr. Baum in Bad Berka. My top concerns are: 1) choosing a clinic that provides great treatment and, 2) getting in as soon as possible. Looking for opinions on these two doctors and any others I should consider.

I have collected as much contact info as I can find from this forum (and elsewhere) but any direct emails or phone numbers would be appreciated.

Diagnosed in January, 2011 - PSA 18, Gleason 9

Radical Prostatectomy, lymph node involvement

Salvage Radiation in 2011

ADT since diagnosis

Provenge in 2016 (best estimate)

SBRT radiation to lymph nodes in chest, 2018

PSA steadily rising for the past 7 years but has taken off in the past 10 months, 11.59 mid-Oct (waiting on result from blood draw yesterday)

3 PSMA scans - the latest, on November 11, showed lesions in pelvis, T5 vertebra, scapula, and several lymph nodes (I'm told they are "small" but any size is too big)

Thank you for the invaluable service you provide with this forum.

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Tall_Allen profile image
Tall_Allen

I like Heidelberg because the innovations seem to be coming from there, but patient treatment may be better elsewhere - I have no idea. I also think it's a good idea to get an FDG scan too to see what the PSMA therapy may miss. Remember, that is there are significant amounts of non-PSMA-avid tumors, you will be eliminating their competition. For this reason, it may be a good idea to eliminate the non-PSMA bulk, if any, with chemo first.

WhiteStrat profile image
WhiteStrat in reply toTall_Allen

I have had FDG scans in the past but it has been a few years. In early October, I had a bone scan with Technetium 99m labeled diphosphonate. Regarding the non-PSMA-avid tumors, what about sequencing the chemo after the LU-177 (with or without ACT-225)?

Tall_Allen profile image
Tall_Allen in reply toWhiteStrat

No. Before. You would need a recent fdg. The issue is heterogeneity. You want to kill off all the cancer cells you can with hormone and chemo therapies and get most of what’s left with the PSMA only therapy.

GP24 profile image
GP24 in reply toTall_Allen

I have a different opinion. I prefer to kill off the cancer cells with radiation and Lu177 and then get what's left with ADT and chemo.

ADT works much longer in a recurrence situation than as a primary therapy.

Tall_Allen profile image
Tall_Allen in reply toGP24

I think that for most people, the sequencing will not matter, as long as the cancer is highly PSMA avid. However, we've seen on this site several reports that PSMA-targeted therapy did not work in men who were PSMA-avid, and the men seemed to decline faster afterwards. In some men, there is a rebound effect - the cancer progresses faster afterwards. This is due to heterogeneity. Recent evidence is that PSMA expression is highly heterogeneous - both within tumors and between tumors.

The implication of heterogeneity is that PSMA-targeted therapy will selectively allow the survival of any remaining cells that do not express PSMA. Those cells, now no longer competing with PSMA-expressing cells for space and nutrients, multiply faster than ever before.

There is no way around this with current technology, which is why PSMA-targeted therapy is not curative. But by reducing the tumor load before PSMA therapy, one can minimize the selective pressure.

This is similar to the approach we take with hormonal therapy. There is no doubt that it also exerts selective pressure on castration-resistant cells, but the effect of reducing the tumor load outweighs the effect of selective pressure, so men taking ADT with, say Zytiga or docetaxel, survive longer.

I think heterogeneity increases with time, so earlier is probably better. However PSMA expression is low at the start, so there is probably an optimum time for PSMA-based therapy - not too early, and not too late. My friend who is newly recurrent has one tumor that has no PSMA expression (on IHC) and several liver tumors that are PSMA-avid (on IHC). He is undergoing chemo now with cabazitaxel+carboplatin, which seems to be shrinking all of his tumors. He will soon have both the FDG and PSMA PETs at UCLA. If FDG is not prevalent after chemo, he will go to Germany for PSMA-targeted therapy.

GP24 profile image
GP24 in reply toTall_Allen

I have read quite a number of studies about Lu177 treatments but I do not recall having read of a rebound effect being mentioned. Usually patients are treated who have failed all conventional treatments. If Lu177 does not work well then, they have a very short survival time.

My understanding is that Lu177 treatment is not curative because the PSMA PET/CT will only show mets with a sufficient SUV. Lu177 also needs this amount of SUV to find and attach to the tumor cells. So the very small, invisible mets escape and continue to grow.

The Lu177 treatment will also destroy castration-resistant cells. So one can argue that systemic treatment may work better after Lu177 because then there are fewer castration-resistant cells left. Selective pressure may have less effect because there are fewer castration-resistant cells.

Prof. Hofman stressed at the APCCC 2019 the importance of having a FDG PET to determine if there are PSMA negative tumor cells. He even asked the audience to vote for adding this to a PSMA PET/CT when the voting would be done the next day. So most of the panellists did that.

He presented the results of his Lu177 trial with 50 patients and compared this with the retrospective results from Lu177 treatments in Germany. In his study he had excluded patients based on the FDG PET/CT results and got much better results than the studies from Germany which had not done that: up.picr.de/37234321wk.png

I have added the study from Prof. Baum which he presented on a separate slide. Then he showed what happened to the patients he had excluded from the Lu177 treatment: up.picr.de/37234323fp.png

As you can see, these patients had a median overall survival of 2.5 months after being rejected. I would have treated these patients and maybe they would have had a median survival of 7.5 months then. I personally could not reject a patient and tell him he has to die in 2.5 months now because he got rejected.

Finally he showed that the PSA decline was prognostic for overall survival:

up.picr.de/37234325mw.png

The patients with a PSA decline of 50% or more had an overall survival of 18.4 months while the remaining patients had just 8.7 months. These patients had failed Docetaxel and half of these Cabazitaxel as well before being treated with Lu177.

I have no way to prove or disprove what Prof. Hofman presented, I just feel, even if the patient has some PSMA negative tumors, he may still benefit to some extend from a Lu177 therapy. This has fewer side effects than trying yet another chemo therapy.

In Germany, if you have a good and expensive health insurance, this will pay for PSMA PET/CTs and Lu177 treatment. So patients prefer this to avoid the side effects of a chemo. Also, the treating physicians think it will be more beneficial than a chemo.

If you have to fly to Germany and pay all the costs out of your own pocket it is different. Then it makes sense to have a FDG PET/CT to estimate how beneficial a PSMA PET/CT will probably be. Or get a chemo which is payed for by your health insurance.

Tall_Allen profile image
Tall_Allen in reply toGP24

This rebound effect came up with Jeremie Calais at UCLA; we've also seen anecdotal reports on this site. The VISION trial allowed for the observation of many patients, and we will learn a lot from it. SUV is an indicator of PSMA avidity. A more discriminating measure can be obtained by tumor IHC analysis. Having just a PSMA PET may mask the fact of heterogeneity in the tumor. There is both heterogeneity within the tumor and between tumors of the same patient. The more heterogeneity, the weaker the response to the PSMA-based treatment, even if there is good PSMA uptake.

europeanurology.com/article...

The fact that survival is lower among patients who have had chemo reflects the fact that Lu-177-PSMA-617 is usually the last option used, after chemo, when the cancer has already progressed a lot. To determine whether chemo or advanced hormonals are advantageous in increasing the effectiveness of Lu-177-PSMA-617 therapy by reducing the tumor load, as I hypothesize, we would need a randomized clinical trial with some men pre-treated with chemo/advanced hormonals and some not. We also know that advanced hormonals create a temporary increase in SUV.

Tumor heterogeneity also has implications for the choice of Ac-225 vs Lu-177. The beta particles of Lu-177, while less thorough in killing the cancer, have a wider range - about 125 cells. The alpha particles of Ac-225, which kill local cancer cells irrecoverably, have a very narrow range - about 8 cells. So larger and more heterogeneous tumors may be better killed by multiple applications of Lu-177.

GP24 profile image
GP24 in reply toWhiteStrat

Comparing PSMA PET/CT with FDG PET/CT is done in Australia but not in Germany. I agree, if most of your tumor is PSMA negative I would not have a Lu177 therapy. But if it is only 10% of your tumor that is PSMA negative, I would still get the Lu177 to remove 90% of my tumor. Yes, you can get a chemo after a Lu177 treatment.

Prof. Baum is leaving Bad Berka end of this year. So you will get the Lu177 treatment in Homburg a bit faster, probably.

WhiteStrat profile image
WhiteStrat in reply toGP24

What you and Tall_Allen are saying makes sense to me. I'll ask my MO about scheduling an FDG PET/CT. It's been a while since I had one and it wasn't on my current MO's orders. I am concerned he may not agree to it. If that's the case, any recommendations?

Tall_Allen profile image
Tall_Allen in reply toWhiteStrat

FDG is the easiest PET tracer to get - I don't think it will be a problem. NIH is running a clinical trial where all patients are getting both (and NaF in those with bone mets). You can point it out to your MO.

clinicaltrials.gov/ct2/show...

WhiteStrat profile image
WhiteStrat in reply toTall_Allen

I have gone back through my records and the last FDG PET/CT I can find was on March 30, 2017, when I was diagnosed with throat cancer. On that skull to thigh scan, there were no FDG avid tumors other than those related to my throat cancer, which were blasted to kingdom come. I feel relatively certain I had another FDG post treatment but haven't found it yet. The good news is this scan was ordered by a UTSW MO and that is where my current MO practices. My plan right now is to push forward on both fronts and choose the correct path after the FDG PET.

I can't say enough about how much I enjoy and appreciate everyone's input.

MateoBeach profile image
MateoBeach in reply toTall_Allen

Just getting up to speed on this. But from the review article on PET radiotracers below I do not see why you suggest FDG PET over Flucyclovine for evaluation of non-PSMA expressing mets? Clarification appreciated.

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

Tall_Allen profile image
Tall_Allen in reply toMateoBeach

The problem is that PSMA expression declines over time, and the metabolism changes. As metabolism changes, the cancer digests less fats and proteins, and more sugars. So the more progressed tumors show up on FDG.

MateoBeach profile image
MateoBeach in reply toTall_Allen

Thank you. Makes sense now.

Have you had any second-line ADT such as Zytiga or Xtandi? And it also looks like you haven't had chemotherapy either. Personally, I would look at those first. Second-line ADT first if you haven't had it, then chemotherapy. Those treatments have more evidence to support their effectivity than LU-177 or AC-225.

WhiteStrat profile image
WhiteStrat in reply to

I took Xtandi from approx 2014 to early 2018. Since then, I've been taking Zytiga. I have not had prostate cancer chemotherapy but, in 2017, I had chemo (cisplatin) and radiation for throat cancer. I know that doesn't exactly count. The side effects from the radiation were quite miserable but it was a refreshing experience to have a cancer that all doctors involved told me was curable.

in reply toWhiteStrat

Glad to hear you had second-line ADT Xtandi and Zytiga, especially with a PSA that took a long time rise. Sounds like you got a good run out of ADT.

Have you done molecular testing? That might also open up a treatment possibility if your cancer has certain mutations.

Not trying to discourage you from LU-177 or AC-255, I would just save it because Docetaxel chemotherapy has more evidence to support it. I've been through it and like most people, the side effects were not that bad. That's my opinion based on what I've learned. It's something you could discuss with a Medical Oncologist.

Wishing you the best in whatever you decide.

WhiteStrat profile image
WhiteStrat in reply to

In January, 2019, my original tumor was subjected to molecular testing by Caris. Although there were mutations, the analyst concluded there were no known therapies with potential benefit. I realize my current tumors could yield a different result but I haven't had biopsies on any of them (and, as of today, have no plans to do so).

It looks like you and Tall_Allen agree that chemo should come before LU-177 or ACT-125. Just when I think I have my mind made up, I get more info and have to reevaluate. I find my current Med Onc to be too "inside the box." My initial Med Onc retired in 2017 and I have not been able to find one I love since then.

in reply toWhiteStrat

Not sure if that's what you meant, but I would think someone who is "inside the box" is someone who follows established and proven treatments. The way see it, I want to do those first. Then when those are used up move on to the experimental treatments like LU-177 and AC-225. Until there is phase 3 trial data, treatments are experimental. I think these new radionuclides have a lot of promise, but we don't have much data yet. On the other hand, there is quite a bit of data on Docetaxel and second-line Cabazitaxel. That's my argument.

EdBar profile image
EdBar in reply toWhiteStrat

You must be referring to Dr. Myers as you’re previous MO. I agree, I miss him and nobody else like him. I’m currently seeing Dr. Sartor who was highly recommended by Snuffy, he’s very much “in the box” and treatment is based on trial proven treatments which I’ve come to accept. He’s also extremely knowledgeable about PCa.

He’s currently one of the leads on a phase 3 trial of LU here in the US, results should be available in 2020.

Ed

WhiteStrat profile image
WhiteStrat in reply toEdBar

You are correct that it was Dr. Myers. I miss him as well. He referred me to Dr. Sartor who I saw several times. I think he is very bright but, perhaps, too busy. I am now at UTSW in Dallas.

ToniTbird profile image
ToniTbird

My hubby is in Heidelberg right now and just got first treatment. He was released this morning and coming home tomorrow. He applied a week ago and got the okay on Monday and they asked if he could be there by Thursday! If you are excepted after medical review, it's a quick turn around! I'll have lots more info when he gets back! Yesterday they did a PET scan to see if medicine did well and it attached to do his cancer areas!! Hoping the tumors start getting blasted ASAP! Hubby said he wishes he did this when first diagnosed 2 1/2 years ago, but we didn't know. We tried to get into a trial last year and was put into the control group for Lu177, but this new combo much better!!!!!

ToniTbird profile image
ToniTbird

My hubby who is a doctor thinks this is the only way to smart bomb cancer. He says chemo is just kicking the can down the road.

in reply toToniTbird

I feel like that is pretty much what all these treatments do.....kick the can down the road. Not sure how LU177 or AC225 are different?

It is funny, I am looking and feeling fairly well right now. I am convinced some people think I am not really that sick. They don't understand that I am kicking that can down the road but I am not cured.

in reply to

I see your comment about people thinking you are not sick. Yesterday I was thinking about writing a post on that subject. I saw one of those "click bait" articles titled: Strange Things People Write on Gravestones. One was "I told you I was sick"

I had someone not too long ago say to me: "I'm so glad you got through this." I really didn't know what to say.

ToniTbird profile image
ToniTbird

My hubby's top notch oncologist at Tulane saved his life last December, but now says they have used all their tricks currently known to them to help. They are starting a trial on AC225 in a couple months, but my hubby doesn't have time to wait that long and the study is for only 1 dose!

The oncologist told my hubby that going to Heidelberg was the best thing he could be doing!

WhiteStrat profile image
WhiteStrat in reply toToniTbird

So glad your husband got in so quickly and hope this treatment annihilates those cancer cells. Dr. Ezziddin in Homburg has already responded to my email. That is amazing to me. His clinic is at capacity so he has forwarded my info to several places, including Heidelberg. My guess is I will end up over there sooner or later. I just have to make up my mind about the order of things - chemo before or after LU-177.

GP24 profile image
GP24 in reply toWhiteStrat

I would get the Lu177 treatment before chemo:

jnm.snmjournals.org/content...

"Chemotherapy-pretreated patients had a significantly shorter survival (median OS 19 months) as compared to chemotherapy-naive patients (38 months, p<0.05)"

WhiteStrat profile image
WhiteStrat in reply toGP24

thank you. that is useful information

in reply toGP24

The problem I see with this retrospective trial data is that we don't know whether those that had longer OS were the just ones that did the treatment earlier. Those that did it after chemotherapy probably did the treatment later on than those that did it after second-line ADT (Xtandi and Zytiga). That is a guess, but I think it's likely.

They also point out at the end of the article:

Randomized controlled studies are required to best determine the place of this agent (for e.g. before chemotherapy) in the management of mPC.

GP24 profile image
GP24 in reply to

Most studies ask for randomized controlled trials at the end of the article but almost nobody does these. Greg, this study is not the final word on this, I agree. But do you have a study that shows that chemo before Lu177 is the better choice? Currently we have to make our decisions based on this type of studies.

in reply toGP24

I don't know if there are any studies that show chemo first is better and I'm not arguing that. I'm arguing that we don't know whether the sequence is significant at all.

At this point, I think we should evaluate the two treatments based on the data we have as to their effectiveness, independent of sequence. My opinion is to do the treatments with the most evidence first.

There has been endless debate about the ideal sequence of prostate cancer treatments. I'm not sure that will ever be completely settled.

GP24 profile image
GP24 in reply to

"My opinion is to do the treatments with the most evidence first. " This will always result to choose the treatment that has been available for longest time. I assume some new treatments may be better than the ones that had been available before the new treatment was developed.

I think the Lu177 treatment will be more effective if it is not used after all other available treatments failed.

in reply toGP24

I agree that some of the new treatments will be better than the ones available, that's our hope for sure. But if a treatment is considered to be better, there should be data to back that up.

Also agree that doing treatments earlier is preferable if possible, but then something has to be last. I do think that the treatments used last tend be thought of as less effective because the disease is so advanced and the patient's condition poor.

GP24 profile image
GP24 in reply to

The Lu177 therapy has not been developed by big pharma so there are no large trials to get an FDA approval yet. The VISION trial shall result in an FDA approval. So far the doctors and patients have been excited by the results of the Lu177 and Ac225 treatment and this has spread the word.

In Australia they are running a trial comparing Lu177 and Cabazitaxel. The have already included the 200 patients they planned and now observe what results they get.

clinicaltrials.gov/ct2/show...

in reply toGP24

I'm hopeful that the results will be good. There was a small phase 2 trial completed fof LU-177 that showed positive results (median PFS of 6.9 months).

I'm happy for any and all treatments that we have available. I'm hoping to have the option to get either LU-177 or AC-225 some day. My doctor said he thinks the new PSMA-based radioisotopes could eventually make Xofigo obsolete.

in reply toGP24

Thanks for the link to the Australian study. I just read it. They are comparing LU-177 to second-line chemotherapy Cabazitaxel. All of the patients in the study have had prior treatment with Docetaxel. It will be interesting to see the results of this.

6357axbz profile image
6357axbz in reply toGP24

Yes, I remember this result. I think Patrick posted it originally a while back.

WhiteStrat profile image
WhiteStrat in reply toToniTbird

Did your oncologist help with getting to Heidelberg or did you do it yourself? Either way, do you have the email or phone number of the person I should contact?

ToniTbird profile image
ToniTbird in reply toWhiteStrat

My hubby did it himself. He gets home tomorrow. I'll have him send you info on Monday when he's not so jetlagged. This is best option!! They did a combo of Lu177 and AC225. He's going to write a blog about his journey for other men to know what he had to learn! 😊

Tall_Allen profile image
Tall_Allen in reply toWhiteStrat

Try Uwe Haberkorn: Uwe_Haberkorn@med.uni-heidelberg.de

Phone: 06221 56-7731

I'm told phone is better.

ToniTbird profile image
ToniTbird in reply toWhiteStrat

Husband here: Just returned from Heidelberg trip #1. Excellent experience with low difficulty factor.

I signed up on the online medical application form, answering questions about my medical condition and treatment desired. Have your latest oncologist, urologist, nuc med, and general\family practitioner notes handy to scan and upload.

Application page here:

heidelberg-university-hospi...

Also have your most recent CD-ROMs with bone scan, CT scan, ultrasound, PET scan ready to go. You'll get a link to download a Java program to upload the images. It seemed straight forward to use.

These notes and scans get reviewed by the Nuclear Medicine docs to give you the thumbs up. If they need more info, they'll ask. They were not concerned about my out of whack labs like liver and CBC\platelets. The doctor said those will improve when the liver & bone marrow no longer have cancer in them. He was probably more concerned about renal function, which is how the radioactive molecules are eliminated.

You'll be assigned an "IO-#" by the International Office, which has probably 20 case workers. Heidelberg is a huge center for international to come to get treatment for all sorts of diseases.

This IO-# is to be referenced from this point on to discuss your case, and most importantly when you wire money.

From the time of filling out the online application\uploading documents to acceptance was 5 business days, for a treatment date three days later! It moves fast, so be ready to say "Yes" to the offered date. They don't have a backlog, so they can get patients in immediately.

Once you are accepted for treatment, you need to wire the money IMMEDIATELY or ASAP, as you don't want to show up to Heidelberg hospital four days later and the wire is not complete (it is NOT instantaneous!). Bring the wire receipt from your bank with you showing all the proper wire & bank number information. The intl office will give you detailed wire instructions but email document, which you need to print and take to your bank... Did I say IMMEDIATELY?

TRAVEL: You are better off calling your airline of choice and explain you are going for a medical treatment, and they probably give you a much better price than the "last minute" pricess you'll find online. For treatments 2, 3 & 4, you'll be able to find better prices a couple months ahead (yes, treatments are two months apart, +\- 1 week)

My wire for my first treatment, doctor fee and tests: 9800Euros (about $11k)

Heidelberg does only a combined treatment of *both* 177Lu & 225Ac-PSMA.

The 177Lu allows the PET scan to determine proper uptake to cancer areas on post injection day #1. The 225-AC has a weaker short range alpha particle that the PET scan cannot detect, so you get both.

The doctor draws the blood, starts the IV and injects the two compounds that are mixed in two syringes. Injection is over about 30 seconds is all for each syringe.

I had to drink 2 liters of water on the first day, besides getting 2 liters of IV fluids on the treatment day, and 1L the next day.

I was released after 2 days of radiation isolation ( family can only visit for one hour a day)... Federal German rules. I left about 8am after taking a required shower. Oh yes, bring your own towel, slippers and PJ too and bottom... Not supplied by German hospitals. A comfortable track suit seemed to be a common item worn by patients.

The hospital food was very good, with an afternoon coffee\tea time. Nursing staff were very friendly and conversant in English. The doctors have very good English, and travel to America annually for professional medical conferences to speak on PSMA treatment.

I will be putting together over the next week a very detailed blog with photos about travel, trains, buses, finding the "Kopfklinic" hospital entrance, finding patient registration and the Intl Office (I.O.) inside the hospital, etc.

Find my blog at

Matthewrings.blogspot.com

As of tonight (Nov 18, 2019) info on there is still pending. I'll try to have more details up by the end of the week. The above tentative information should get you rolling though!

WhiteStrat profile image
WhiteStrat in reply toToniTbird

Thank you for the detailed information. Knowing what to expect makes the process so much easier.

Since my last post, I have had several emails from Dr. Ezzidden in Homburg. He is at capacity so he passed my info on to TUM and Heidelberg. Dr. Eider from TUM has emailed and, tentatively, I am accepted for treatment there. No details, or request for medical records yet. I called Heidelberg and was directed to the International Patient Application page you described. Today, I filled it out and sent the requested medical records. My iMac and the Java program didn't play nice so I sent an email requesting guidance. Haven't heard back yet but I'll do whatever is necessary to get my images to them soon.

It sounds like your experience was very positive. I hope that the treatment is successful and blasts the cancer cells into oblivion.

Cosette100 profile image
Cosette100

Cant wait to hear his comments and hope the results are positive.

j-o-h-n profile image
j-o-h-n

Whatever way you choose.... never look back.... and I do hope you choose the one that's gets you the best results.... Kill the MF bastards.....

Good Luck, Good Health and Good Humor.

j-o-h-n Saturday 11/16/2019 10:42 PM EST

immunity1 profile image
immunity1

Late onto this thread. I have had a goodly session (x4) of Lu177 in 2017 following diag in 2010, RP (Gl9), adj RT, and combined ADT. I am now undergoing docetaxel infusions. I think it is hard to pick the best sequence; whether to undertake Lu177 initially or not. I did, with re-emergence of oligometastases (6) all soft tissue - which may have been important - around the prostatic bed. Prior to Lu177 in 2017 my PSA was 1.0ug/L. This treatment probably delayed PC progression by 12 - 18 months, with zero side effects. Currently, I do have PC progression with pelvic, lumbar mets that are mostly PSMA and FDG discordant. So I have recently had RT for palliative care, currently undertaking docetaxel for these discordant lesions (which anecdotally don't seem to respond so well to Lu177). And after that, maybe a wee whiff of Lu177 to mop up the remainder of the PSMA-avid mets that are holding out. I have other plans afoot, but that is another story...... =Rob.

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