Kicked out of the SPLASH trial - Advanced Prostate...

Advanced Prostate Cancer

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Kicked out of the SPLASH trial

joeguy profile image
69 Replies

Sadly, my run on Lu177 in the SPLASH trial ended before the second injection. I appear to have had zero benefit from the first injection, and actually showed significant progression in the 2 months since receiving the first dose. Somewhere in the trial fine print, it states that progression while in the trial will end your journey. Going to see the local oncologist tomorrow about starting Docetaxel . They claim Docetaxel only adds a couple months of survival, but as long as its tolerable, why not....

69 Replies
NickJoy profile image
NickJoy

I'm really sorry to hear that. I came across this trial today and I don't know if it is helpful to you but I thought I would let you know. Maybe someone else will have an idea if it could be useful.

clinicaltrials.gov/ct2/show...

Tall_Allen profile image
Tall_Allen

I'm sorry it didn't work. I wish they would screen patients with FDG PET scans too.

Consider Xofigo+Docetaxel+Provenge if there is any bone pain.

prostatecancer.news/2021/02...

joeguy profile image
joeguy in reply to Tall_Allen

thanks........ I had high hopes for Lu177 for a couple of years now..... very disappointing

maley2711 profile image
maley2711 in reply to Tall_Allen

Wow...must have been quite an effort to compile all the info in that article....thanks ! Have you put together anything that drills down on which situations suggest the use of bone-strengthening agents...and in what circumstances do the benefits of such agents not outweigh the probability and seriousness of SEs of such strengthening agents. Reasons for underprescription ??

Tall_Allen profile image
Tall_Allen in reply to maley2711

This has nothing to do with the OP's situation.

maley2711 profile image
maley2711 in reply to Tall_Allen

sorry?????

Fightinghard profile image
Fightinghard in reply to Tall_Allen

TA. The SPLASH trial does offer the FDG Pet scan as suggested option. But not required to take the extra scan for participation in the trial

noahware profile image
noahware

Sorry to hear.. good luck with the chemo!

joeguy profile image
joeguy

thank you

Ollie1948 profile image
Ollie1948

Joeguy , hopefully chemo will be a better option in your case. Best of luck

joeguy profile image
joeguy in reply to Ollie1948

thanks, have you had your second dose yet?

Ollie1948 profile image
Ollie1948 in reply to joeguy

not yet, to be on 24th.... so far I am feeling great but you never know those scans.

Kaliber profile image
Kaliber

just adding to the chorus of brothers here , that’s so disappointing. Hoping you’ll have much better results with docetaxel …maybe get the triplet therapy TA mentions. Dang …

💪💪💪❤️❤️❤️

joeguy profile image
joeguy in reply to Kaliber

thanks kaliber

Fightinghard profile image
Fightinghard

hi joe

I was booted from splah after round 3 due to progression plus severe bone pain reaction. Doing the dox chemo now. Just had round 2 chemo. Tests indicate it is having oositive impact. Hoping togain more than 2 months from it!!

joeguy profile image
joeguy in reply to Fightinghard

how are your doxetaxel side effects? I have heard as far as chemos go, it’s fairly well tolerated. Also hoping for better than 2 extra months…….. Hate that they always seem to talk about survival benefit of these various treatments in terms of months

London441 profile image
London441 in reply to joeguy

Docetaxel is mild comparatively. Also no doc can tell you what you’ll get from it, some get years not months.

Linebacker75 profile image
Linebacker75

I’m sorry joe. My prayers that you will find another treatment. Keep on pushing back brother.

dockam profile image
dockam

Oh Dang my Brother, so sorry to hear that.

Hope for success with Docetaxel, in 2015 15 sessions got my PSA from 840.2 to 0.7 with 1st gen ADT CHAARTED trial. Eight years in with 24 additional chemos, and I'm still in the game 💙

Life is Beautiful

Fight, Live, Love, Laugh, and QoL on

Randy

joeguy profile image
joeguy in reply to dockam

how did 15 doses of doxetaxel treat you? Trying to figure out what to expect

dockam profile image
dockam in reply to joeguy

Hey, sorry I answered in the box below and not as a reply, I blame ADT :-)

dockam profile image
dockam

Hi, in 2015 I saw Dr. Valter Longo research about fasting and chemo. So, for each of the chemos, I did a 2 day fasting, sipping on tomato, veggie, curry, garlic, ginger broth. I was spared the bulk of the side effects, just hair loss with Docetaxel, but not with Cabazitaxel

karger.com/Article/Fulltext....

cancercenter.com/community/...

breastcancer.org/research-n...

youtu.be/SybTjP5LLhs Dr Longo in this vid

I also did exercises during the sessions, doing leg lifts, scissor kicks, squats. I never got neuropathy and my 1st MO and I surmised that my marathoning had caused all of the very tiny blood vessels in toes, fingers and eyes and being wide open meant they were well oxygenated. When back home I'd go and take a walk to move the chemo thruought

Some use ice packs to constrict those vessels and prevent much chemo from getting thru.

In 2015, I still worked 6 days per week, and managed marathons also that year.

tehachapinews.com/lifestyle...

So ads say "Individual results may vary" but make the outcome better by doing things to offset them

Search the above right box for more info from other members here.

My Best to you Brother

Randy

joeguy profile image
joeguy in reply to dockam

Thanks Randy. I would think not having any food on your stomach might increase the nausea effect..... I tend to get a little nauseated when taking some meds on empty stomach.

dockam profile image
dockam in reply to joeguy

Good Morning, Oh okay, but the nausea is with taking Oral meds on an empty stomach?

Maybe IV meds wouldn't cause nausea

I was also given Pepcid and IV Benadryl with chemo and both reduce nausea

Maybe the Fasting Mimicking Diet would help prolonfast.com/products/pro...

pakb profile image
pakb in reply to dockam

My husband did the same when he did docetaxel. I had him fast the day before- but he did have a protein shake during- as well as lots of electrolytes. He worked out almost every day too. And continued working his job. He lost all his hair- he was already bald but lost other hair- eyebrows, leg hair etc- that never grew back. To this day he can't grow a mustache- but can grow a goatee! He's over 5 years from chemo- he benefitted from the results of those trials- chaarted and stampede?-and did chemo plus ADT from diagnosis. Overall I'd say he tolerated chemo better than we had thought.

dockam profile image
dockam in reply to pakb

That's wonderful and Yay for a great outcome 💙

Yea, I still don't have eyebrows😂

My MO told me in 2015 at initial consult that I was diagnosed at right time as the CHAARTED trial showed a 17 month advantage with ADT/Chemo combo and thus I got to still be here 8 years later, old data said only 28% chance of making 5 years😁

and I'm still Standing photos.app.goo.gl/mk7QjCTVS...

Fight, Fast, Live, Love, Laugh, and QoL on

Randy

pakb profile image
pakb in reply to dockam

My husbands MO said the same in 2017. So grateful for the guys who sign up for these trials! My husband this summer... 5 years almost to the day of his stage 4 Gleason 9 diagnosis 💙

Surfing
dockam profile image
dockam in reply to pakb

So awesome

youtu.be/af2rY1bmfZM

Gearhead profile image
Gearhead

When they excuse someone from a trial for reasons like this, why doesn't that compromise the integrity of (i.e., bias) the statistics?

joeguy profile image
joeguy in reply to Gearhead

I assume I will forever be a number in the trial for “ failed due to progression “

Sunlight12 profile image
Sunlight12

Very sorry to hear this, Joeguy. I'm sure it must be disappointing. Take a deep breath and hang in there. I noticed you were wondering about docetaxel side effects. It tends to be one of the well-tolerated treatments. My Dad had a compromised liver and still handled it well. We did not do anything special in terms of cold caps, etc, although many people here have and have found them helpful. (See this extensive post for tips: healthunlocked.com/advanced...

I hope the docetaxel contributes positively to your journey. Sending massive good thoughts your way!

In solidarity,

Sunlight

joeguy profile image
joeguy in reply to Sunlight12

thank you

Allan65 profile image
Allan65

so sorry to hear of your situation. Good luck with the chemo

joeguy profile image
joeguy in reply to Allan65

thanks

Izzygirl1 profile image
Izzygirl1

I’m sorry your trial had to end early. My husband did well with Docetaxel and I hope you will too!!!

joeguy profile image
joeguy in reply to Izzygirl1

thank you

Ramp7 profile image
Ramp7

I was able to complete all 6 infusions of LuPSMA177. But PSA is rising once again. Meeting with Dr. Denmeade to discuss BAT.

joeguy profile image
joeguy in reply to Ramp7

how long did the Lu keep your PSA down ?

Ramp7 profile image
Ramp7 in reply to joeguy

after the 3rd infusion, slowly going up.

gsun profile image
gsun in reply to Ramp7

Please report back on the BAT.

Ramp7 profile image
Ramp7 in reply to gsun

last PSA 2.0

joeguy profile image
joeguy in reply to Ramp7

mine was 9 when starting Lu….. 40 after first dose

Ramp7 profile image
Ramp7 in reply to joeguy

I started at 8.1, dropped after two doses to 0.19. But then steadily rose to 0.5. I guess a mixed result. They were happy I finished all six.

Ramp7 profile image
Ramp7 in reply to Ramp7

I've employed a BAT protocol. Shall be getting my T and PSA checked next week.

fmenninger profile image
fmenninger

sorry to hear about getting the boot. Stay positive and push for triple therapy.

pilot52 profile image
pilot52

Is India possible for you...They do have AC-225 and also the simplest way to describe is a combo of Ac & Lu. the nice thing about this one , the AC spins off only one daughter cell that hits other PSMA avid tissue...Straight Ac-225 spins off 4. Logistics are easy and I can help. I can also outline cost...I am headed back on the 19th.

joeguy profile image
joeguy in reply to pilot52

Thank you for the suggestion. I would need to look into if after failing Lu177 in a spectacular way, is there a possibility it could work in combination with AC ?

pilot52 profile image
pilot52 in reply to joeguy

Contact Ishita Sen at Fortis. She will give you a straight forward medical option if there is one available in the nuclear medicine department. On my first round two years ago I had a heavy tumor load. She gave me an honest assessment for me to make a decision. She seems to have ( and I could be wrong) more leeway than Hoffman and I think this is only the government controls in place in Western Countries. Side note...my last Lu-177 infusion the meds came from Canada...So I flew to Delhi, to be infused with meds sent from Canada....Quite efficient do you not think? Blue Skies my friend and find that tail wind......

MateoBeach profile image
MateoBeach in reply to pilot52

Is that with Ishita Sen? I didn’t know she was doing the Lu +Ac combo.

Cooolone profile image
Cooolone

Sorry to see your development while trying to obtain therapy ... Is very unfortunate. I hope the chemo will prove effective, even if for a time!

But your example is why for us patients, it is hard to trust numbers. Disqualification for trial(s) even while already entered into one is akin to cherry picking data. They can make things appear better than they are, or is it they just want to prove efficacy for certain risk stratification? We won't know... Again, is why you (we) all need to read the fine print of the data when published from these trials. It will surprise you of you do.

Wishing you the best regards!

joeguy profile image
joeguy in reply to Cooolone

thanks coolone

dadsdrdawn profile image
dadsdrdawn

I am sorry that you were kicked off of THIS trial - but keep your mind clear that NO DOCTOR knows, and no medication should state - "how long you have" and I find it negligent that ANYONE (Dr. or whoever) thinks they know the timeframe. I LOVE my parents Dr. Geo that says "unless you are pulling the plug, or are God himself, you have no right in giving someone that curse of how much time you have left to think of".

With that being said, I have a very good friend that had 2 forms of cancer. She was given 10 months to live - being told by her (horrible person) Doctor, and told to her mother - that "this will be her last Christmas, so make it memorable" -

THAT was 5 Christmases ago.

And, my friend was kicked off of a trial med, and the other people on the medication passed within 2 years. (they were also given 10 months!!!)

So NO-ONE knows how EACH persons body, mind, and the connection to life REALLY works. She's alive. Back to work. Has been Cancer clear for 4 years, and has underlying swelling issues, and numbing issues from chemo in her feet and legs...but is living a FULL life.

- #1. there are new medications that we learn of every day.

#2. If you have the WILL to keep living, you'll fare better than someone that constantly thinks of how they are doomed to die soon (have seen this so many times, and it's so sad)..

#3. There are MIRACLES that we all have seen, and heard of- you just have to believe that YOU are going to be one of them.

I pray that you are! And, I hope you find something that keeps your quality of life HIGH, and your mind focusing, maybe even meditating on how much you want to be here.

And of course, keep digging for other ways to kill off your cancer, and live!

Where there is breath, there is hope.

Sending you much love,

Dawn

joeguy profile image
joeguy

Thank you for your encouraging words Dawn. I am pretty bummed out about being booted from the trial, but I am far from throwing in the towel ....

Jmr11820 profile image
Jmr11820

sorry to hear this. have you sought online second opinions at a place like UCSF? just a thought.

KocoPr profile image
KocoPr

Hi Joeguy, so sorry to hear this news. I failed meeting the criteria for two trials after going through preliminary scans and tests and made it on one trial. I look back on it and am real glad I did not go on those trials. sometimes things work out for the better.

I see that you failed on enzalutamide. Did you get your PSA results in and shouldn't you get genetics testing done to see which mutation or if neuro-endicrine because there are different treatments options for you.

Here is an article you might want to read. It discusses many of the Enzo failure mutations and present and future treatments including trials.

Second generation androgen receptor antagonists and challenges in prostate cancer treatment

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

The utility of these agents has expanded with the emergence of second-generation AR antagonists, which began with the approval of enzalutamide in 2012 by the United States Food and Drug Administration (FDA). Together with apalutamide and darolutamide, which were approved in 2018 and 2019, respectively, these agents have improved the survival of patients with prostate cancer, with applications for both androgen-dependent and castration-resistant disease. While patients receiving these drugs receive a benefit in the form of prolonged survival, they are not cured and ultimately progress to lethal neuroendocrine prostate cancer (NEPC). Here we summarize the current state of AR antagonist development and highlight the emerging challenges of their clinical application and the potential resistance mechanisms, which might be addressed by combination therapies or the development of novel AR-targeted therapies.

joeguy profile image
joeguy in reply to KocoPr

thanks, I actually failed Daroltimide…. Xtandi was stopped a couple years earlier due to cardiac side effects , but I am told they are basically the same drug

KocoPr profile image
KocoPr in reply to joeguy

They are similar but the failures are certainly different. The article I posted above covers Daro failures also.

In contrast to enzalutamide and apalutamide, the most recently approved second-generation AR antagonist darolutamide (ODM-201) has a different chemical structure (Fig. ​(Fig.1)1) and cannot cross the brain–blood barrier [36].

Table 2

Novel AR targeted therapies.

Agents/technologies Mechanisms and preclinical/clinical evidence

AR DBD inhibitors AR binding to the DNA via its DBD is an essential step in the regulation of gene transcription by both full-length and variant forms of AR [163]. AR DBD inhibitors can effectively inhibit the activity of truncated ARVs and repress PCa growth in vitro and in vivo [129, 134, 164].

AR NTD inhibitors The AR NTD is essential for AR transactivation, and NTD deletion renders AR transcriptionally inactive [165]. A phase I trial has established the safety of EPI-506 and provides proof of concept for targeting the AR NTD [133].

AR-targeted PROTACs PROTACs technology has emerged as a promising approach for targeted therapy in various diseases, particularly in cancer [136]. ARV-110 targets AR and is safe and has efficacy in mCRPC patients [137, 138]. A phase I/II dose escalation study is currently recruiting mCRPC patients to assess the tolerability and safety of ARV-110 (NCT03888612).

AR-targeted CRISPR-Cas13 CRISPR/Cas13 targeting of oncogenes has been proven to repress the growth of multiple types of cancer in vitro and in vivo [147–149].

Pianodude profile image
Pianodude

I started Doxetaxel and ADT right after diagnosis. I was supposed to get 6 rounds of chemo. After 5 they stopped it because of worsening neuropathy in my feet. That was really the only bad side effect I experienced. And the 5 rounds did the job. That was just over 2 1/2 years ago. I hope it is as easy and effective on you as it was for me.

CAMPSOUPS profile image
CAMPSOUPS

Sorry to hear this Joe, Your anticipation of good results had to make this hard to take.

I just had my trial treatment (docetaxel or arm with docetaxel and Xofigo) halted about 4 or more weeks ago.

IMHO I think the Docetaxel will be good for your treatment. It might bring some progression free time by itself or will be a good way to "resensitize" your cancer cells so that Xtandi etc. is of more benefit.

The 2 month thing is not really even in the ballpark.

In the long run what your MO conveys to you will be the best information and options.

joeguy profile image
joeguy in reply to CAMPSOUPS

thanks camp…. How were your side effects with Docetaxel?

garyjp9 profile image
garyjp9

I'm sorry to hear this Joeguy. Best of luck with the docetaxel.

joeguy profile image
joeguy in reply to garyjp9

thank you

WSOPeddie profile image
WSOPeddie

Don't believe the "couple of months survival" BS. That's bogus.

joeguy profile image
joeguy in reply to WSOPeddie

I always thought so too. But it does seem like most all of the treatment’s for late stage PC are always in terms of a few extra months . Would be nice if they were a tad more optimistic

wagscure259 profile image
wagscure259

Sorry to hear of the failed treatment. I was recently scheduled to begin a trial of an androgen receptor degrader but high creatinine levels and kidney hydronephrosis kept me from beginning it as a result of a lymph node encroaching on the ureter. I was immediately started on docetaxel, so I’ve completed one infusion and pending another on 2/1. I understand and feel your disappointment but we press on!

joeguy profile image
joeguy in reply to wagscure259

how have your side effects with doxetaxel been? I’m also 1 dose in and had a variety of SEs starting about 3 days after infusion. The worst was horrible spin pain that developed on day 4…. They say that can be from the shot you receive the day after chemo, but not looking forward to that again

wagscure259 profile image
wagscure259

I only had a bit of a metallic taste in my mouth, increased fatigue, some nausea, all minor, and only present days 3-7. I had no injection the day after. My infusion began with 15 minutes of dexamethasone followed by 1 hour of docetaxel then a 15 minute flush. I also was prescribed 5mg prednisone orally twice a day to help ameliorate side effects. I exercise daily including post chemo of albeit a reduced intensity

joeguy profile image
joeguy in reply to wagscure259

I think I had all the side effects….. days 4 thru 8 were no fun

joeguy profile image
joeguy in reply to wagscure259

strange you didn’t get the day after injection. It had to do with white blood cell developement…. Thought everyone got it

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