I have had radiation for a painful Me... - Advanced Prostate...

Advanced Prostate Cancer

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I have had radiation for a painful Met a L5----

nuc1111 profile image
35 Replies

I expect the pain to gone in 2-4 weeks-- Can I do BAT if I don't presently have painful bone mets? Also Hopkins say the flare pain lasts only a week. Preloading and continuing with Nsaids should help the inflammatory response responsible for the flair pain. Thoughts much appreciated,Ed

35 Replies
smurtaw profile image
smurtaw

Hi Ed,

I do not see why you couldn't try it. If you are concerned about the possible pain, you could start with a low dose of Androgel, ramp up if the pain is manageable, it clears very quickly (not like cypionate).

If things go well, start a full fledged BAT program. Cypionate or propionate. If you use cyp you need to use an ARB/ARSI (like Xtandi) on the low T cycles.

I'm always here to help. Let me know if/when you start and I can try to help out if I can.

Russ

nuc1111 profile image
nuc1111 in reply to smurtaw

Russ,

I love the hope you provide in this dismal environment-

Ed

nuc1111 profile image
nuc1111 in reply to smurtaw

Russ

I’m on Lynparza and orgovyx and kept my pad 3-4 range.

Wondering what testosterone level I should shoot for with androgen 50 mg packets-don’t know if I can get high enough with dermal route.

Used 4 for the last 2 days.

nuc1111 profile image
nuc1111 in reply to nuc1111

sorry Psa 3-4 range

smurtaw profile image
smurtaw in reply to nuc1111

500 mg of gel takes me to about 2000 ng/dl.

I'm guessing that if you wanted to judge pain, you could start at 200 mg and go up.

Tall_Allen profile image
Tall_Allen

I don't think so. The pain is a signal that the bone metastases have progressed and that high dose testosterone can cause further progression. BAT is only for men that have never had metastatic bone pain. What does JH say? They are the experts.

smurtaw profile image
smurtaw in reply to Tall_Allen

According to Denmeade it isn't further progression, it is pain from inflammation.

BAT can fail to control cancer, just like any other therapy. JH put in place a 25% PSA increase metric to judge "failure" after 3 cycles.

Do you have trial data to support your statement that high dose T can cause further progression? (or is the rate of occurrence roughly the same as any other SOC or non-SOC therapy)

If you have trial data, please send me the trial name. Thanks.

Tall_Allen profile image
Tall_Allen in reply to smurtaw

None of the BAT trials allow patients who are symptomatic. It is part of the exclusions for each. Many of the trials include patients who PSA has more than doubled in a short period after supraphysiologic testosterone. For example in the C arm of the Restore trial:

• Only 4 men (14%) had a PSA decline ≥50% due to the testosterone therapy

• Only 4 men had a reduction in their metastases. All of those had lymph node metastases only.

• Testosterone therapy lasted for 9 months (median) before radiographic progression was detected

• Maximum PSA response was achieved in 56 days. Only 7 patients had any PSA reduction.

•PSA more than doubled in 52%, and increased markedly in 14% more.

• 31% had some radiographic reduction of metastases.

• Median radiographic progression-free survival was 8.5 months

• Musculoskeletal pain was experienced by 40%

• Other prevalent side effects were: hypertension (21%), breast tenderness (21%), leg swelling (17%), fatigue (14%), and difficulty breathing (10%). One patient died of a stroke.

• 18 patients later received Zytiga or Xtandi, with excellent results.

• There weren't any discernable genomic determinants of response.

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

In short, despite my early hopes, BAT is certainly not what I hoped it would be. It provides an ADT vacation in a minority of patients and makes many a lot worse. It does not extend survival. They have so far failed to come up with a plausible reason why it works in some and fails so miserably in others, although I think that AR activity may be a good biomarker. I hope they continue their trials, but it is not something any patient should attempt outside of a closely monitored clinical trial.

Seasid profile image
Seasid in reply to Tall_Allen

Good to know all this. Thanks

smurtaw profile image
smurtaw in reply to Tall_Allen

Denmeade is very clear that he does not want to include men who might have pain. He is also very clear that any pain is from in inflammatory factors. He and Antonarakis are telling people that they are comfortable with BAT outside of a trial. If you are interested, I can send you Denmeade's contact info. He is willing to help MO's guide therapy.

The use of Hi T - medium/low T BAT as monotherapy without follow-on Xtandi therapy has not been proven to extend life.

Could you comment on the RESTORE, TRANSFORMER, and COMBAT-CRPC trial results?

"BAT appears to increase sensitivity or restore sensitivity to Xtandi (and perhaps other drugs that block the ARs such as bicalutamide). After the conclusion of BAT, certain immune pathways are enhanced, and immunotherapy responses are improved.

In the RESTORE clinical trial, men with CRPC progressing on either Xtandi or Zytiga were treated with BAT. Once BAT stopped working, the patients received the same drug that failed prior to BAT (Xtandi or Zytiga). Of the patients who progressed on Xtandi and then proceeded to BAT and were rechallenged with Xtandi, 70% had a PSA response to rechallenge with Xtandi. For the patients who progressed on Zytiga and then proceeded to BAT and then were rechallenged with Zytiga, the PSA response was much lower at 17%.

In the TRANSFORMER clinical trial, men with CRPC progressing on Zytiga were treated with either BAT or Xtandi. After failure of the starting therapy (Xtandi or BAT) patients were given the option to cross over to the opposite therapy. Thus, men on BAT could go on to get Xtandi and vice versa. For the patients who received BAT first and then received Xtandi, PSA went down by at least 50% in 77.8% of the subjects. For men who received Xtandi directly after Zytiga, the PSA response was seen in 25% of men.

In one arm of the RESTORE clinical trial, men with CRPC who had never received Zytiga or Xtandi were treated with BAT. The PSA response to BAT was low in this group at about 15%. However, some patients in this study went on to receive Xtandi or Zytiga after BAT. In these patients, 95% of the men had more than a 50% decrease in PSA, 85% of the patients had more than a 90% decrease in PSA, and 50% had PSA levels that became undetectable. The duration of response to Xtandi or Zytiga after BAT in this study was over 2 years. As a comparison, in the studies that led to the FDA approval of Xtandi or Zytiga as first‐line therapy for men with castration‐resistant prostate cancer, the PSA response was 78% and 62%, respectively and the duration of PSA response in both studies was 11 months.

"

Also, do you have trial data to support your statement that high dose T can cause further progression? (or is the rate of occurrence roughly the same as any other SOC or non-SOC therapy)

Tall_Allen profile image
Tall_Allen in reply to smurtaw

I just showed you that. Re-read. You appear to be cherry-picking, which is dangerous. But It's your life. Be careful about spreading cherry-picked info. While you may be doing fine, others may b e harmed.

smurtaw profile image
smurtaw in reply to Tall_Allen

Perhaps I can be clearer:

1. Yes or no for trial data supporting your statement that it causes further progression (progression that would not have occurred without the use of high-dose T). If yes, please provide the trial or trials.

2. Yes or no for the rate of occurrence roughly the same as any other SOC or non-SOC therapy. Please provide evidence and numbers.

3. Since all 14 clinical trials I have are cherry-picked, could you provide me a list of trials that I can add to the info I spread?

4. You disagree with Denmeade and Antonarakis when you state "it is not something any patient should attempt outside of a closely monitored clinical trial". Could you elaborate on why you disagree with them?

If you don't mind labeling each answer with numbers it might help me. Thanks!

Tall_Allen profile image
Tall_Allen in reply to smurtaw

Perhaps you should re-read what I wrote paying extra attention to the underlined lines. I think you aren't seeing them because of confirmation bias.

Ask yourself this question - what evidence would convince me it didn't work?

smurtaw profile image
smurtaw in reply to Tall_Allen

If you could please take the time to answer each question it would be extremely helpful to me and likely to others as well.

1. Yes or no for trial data supporting your statement that it causes further progression (progression that would not have occurred without the use of high-dose T). If yes, please provide the trial or trials.

2. Yes or no for the rate of occurrence roughly the same as any other SOC or non-SOC therapy. Please provide evidence and numbers.

3. Since all 14 clinical trials I have are cherry-picked, could you provide me a list of trials that I can add to the info I spread?

4. You disagree with Denmeade and Antonarakis when you state "it is not something any patient should attempt outside of a closely monitored clinical trial". Could you elaborate on why you disagree with them?

I will answer your question and please answer mine.

The evidence that I would need to see is a failure of a properly implemented bipolar androgen therapy to generate therapeutic responses above and beyond the minimum that I could expect from a simpler less harmful therapy. I would want to see this for resensitization, HSPC, CRPC, and combined with chemo, RT, checkpoint inhibitors, etc. - that is, any SOC therapy that I would expect to synergize with BAT.

Have you read this summary ( and could you comment and let me know why it is flawed? This comes from trials and MOs. Is it your opinion that MOs and trials suffer from confirmation bias and if so, what is now considered to be the gold standard?

"BAT appears to increase sensitivity or restore sensitivity to Xtandi (and perhaps other drugs that block the ARs such as bicalutamide). After the conclusion of BAT, certain immune pathways are enhanced, and immunotherapy responses are improved.

In the RESTORE clinical trial, men with CRPC progressing on either Xtandi or Zytiga were treated with BAT. Once BAT stopped working, the patients received the same drug that failed prior to BAT (Xtandi or Zytiga). Of the patients who progressed on Xtandi and then proceeded to BAT and were rechallenged with Xtandi, 70% had a PSA response to rechallenge with Xtandi. For the patients who progressed on Zytiga and then proceeded to BAT and then were rechallenged with Zytiga, the PSA response was much lower at 17%.

In the TRANSFORMER clinical trial, men with CRPC progressing on Zytiga were treated with either BAT or Xtandi. After failure of the starting therapy (Xtandi or BAT) patients were given the option to cross over to the opposite therapy. Thus, men on BAT could go on to get Xtandi and vice versa. For the patients who received BAT first and then received Xtandi, PSA went down by at least 50% in 77.8% of the subjects. For men who received Xtandi directly after Zytiga, the PSA response was seen in 25% of men.

In one arm of the RESTORE clinical trial, men with CRPC who had never received Zytiga or Xtandi were treated with BAT. The PSA response to BAT was low in this group at about 15%. However, some patients in this study went on to receive Xtandi or Zytiga after BAT. In these patients, 95% of the men had more than a 50% decrease in PSA, 85% of the patients had more than a 90% decrease in PSA, and 50% had PSA levels that became undetectable. The duration of response to Xtandi or Zytiga after BAT in this study was over 2 years. As a comparison, in the studies that led to the FDA approval of Xtandi or Zytiga as first‐line therapy for men with castration‐resistant prostate cancer, the PSA response was 78% and 62%, respectively and the duration of PSA response in both studies was 11 months.

"

Have you talked to Denmeade, Antonaraklis, Sena, Sartor, etc or are you forming your opinions on your own?

If you can't answer, just ignore this but please do not try to sidestep it.

Tall_Allen profile image
Tall_Allen in reply to smurtaw

I have never side-stepped a legitimate question, but yours aren't. That's because science works by falsification. You are a true believer, not a scientist. You can easily see it in your answer which lacks legitimate endpoints that can be empirically verified. You state " to generate therapeutic responses above and beyond the minimum that I could expect from a simpler less harmful therapy" But you don't state just what those therapeutic responses are. And I think that you'd agree that a large randomized clinical trial is necessary to compare it to SOC, but the lackluster results so far don't merit such investment.

BTW- Johns Hopkins has an IRB-approved protocol for experimenting on BAT. They certainly do consider it experimental and you are quite wrong when you say they believe it should be done outside of clinical trials elsewhere.

Here is a full list of what's been published on the subject so far. Unlike you, however, I am not trying to prove that it works- I am just collecting the evidence on all sides.

prostatecancer.news/2016/09...

So far, BAT has the following benefits:

(1) It gives some men a monthly break from their ADT

(2) It enables enzalutamide to last longer (without prolonging overall survival)

(3) The benefit, when there is one, seems to be limited to man with lymph node metastases only. There is no benefit in men with bone or visceral metastases.

But...

(1) It does not prolong life

(2) In many men, it seems to speed progression of their cancer . In fact, there is evidence (Markowitz) that half the men had immediate radiographic progression on PSMA PET scans. PSMA PET/CT should be used to monitor progression in all clinical trials. Teply found, using a PSA endpoint, that 43% progressed very quickly. The RESTORE C trial found PSA more than doubled in 52%, and increased markedly in 14% more. 69% had no radiographic reduction of metastases, which would have been expected with SOC therapies.

(3) It puts many men (40% in RESTORE C) in a lot of pain

(4) It does not prolong use of abiraterone,

(5) AR activity may be a valuable biomarker, but to my knowledge, it is only available through a Johns Hopkins lab. There are no genomic biomarkers that separate responders from non-responders.

EdBacon profile image
EdBacon in reply to Tall_Allen

Is it my imagination, or does BAT have somewhat of a "cult" status here on this forum? It seems like this fantasy treatment where you can get your testosterone back (at least part of the time) enjoys a lot of unwarranted support here. Lots of promotion for something that really hasn't been proven to work. It doesn't seem to matter what the evidence is, people will defend it and promote it anyway.

smurtaw profile image
smurtaw in reply to EdBacon

Personally I use it so that I can remain HSPC. Patrick has done the same for 14 years. Mateo for 4.

I guess it's the hormone-sensitive, control PCa, live life cult :)

Seriously, if someone has serious doubts after researching it and viewing trials and discussing with BAT MOs, my advice is not to do it. It isn't something to do halfway and expect good results. The same is true of many therapies and much of what we do in life.

Tall_Allen profile image
Tall_Allen in reply to EdBacon

Some people don't want to be confused with the facts. I just watched a rather long (almost an hour) video by a doctor discussing the kinds of biases that blind patients and doctors (who should know better). He brings up "mechanistic bias" that occurs when we think there is a plausible mechanism that should work.

youtu.be/NmJsCaQTXiE

I think BAT has a place if more clinical trials provide proof and identifies appropriate patients. All the current clinical trials are targeted to men with mCRPC. Johns Hopkins has abandoned doing trials for BAT for mHSPC, probably because there are so may proven effective therapies now.

prostatecancer.news/2016/09...

I really don't see a difference between it and intermittent ADT for mHSPC. With BAT, you get monthly relief for a few weeks. With iADT, some guys get testosterone recovery to baseline values and can go for months or even years on vacation. In fact, I'd love to see a clinical trial that randomized men between the 2 strategies. The proper way to do it is with a closely watched, patient-informed clinical trial. If they are equally safe, patients should have the choice.

TomMaloney profile image
TomMaloney in reply to Tall_Allen

Tall_Allen,

I currently have mCRPC.

A while back I had hypogonadism and my PCP prescribed Testosterone to rub on my chest. Well, my Testosterone went from 0% to 150% in an instant (almost).

I became agitated, argumentative, and aggressive. ['roid rage]

what will be the mental effect on men doing this teeter/totter over and over?

Tall_Allen profile image
Tall_Allen in reply to TomMaloney

Not everyone gets roid rage, but I think it is a valid point. All of the hormonal QOL questionnaires are answered by patients. But perhaps the people who have to live with us should fill it out too.

TomMaloney profile image
TomMaloney in reply to Tall_Allen

Thank you Tall_Allen,

With the 'roid rage, I hated myself. It was a huge personality change.

I was fed up with ADT and on June 30th, 2019 I had a bilateral orchiectomy, which allowed me to drop Lupron Depot, clopidogrel, amlodipine, and meclizine. That orchiectomy was a one-shot deal. I don’t have the balls to do it again.

This got me in touch with my female side and I became nicer and more empathic. Overall I believe it made me a better person.

TomMaloney profile image
TomMaloney in reply to Tall_Allen

BTW Tall_Allen,

Happy New Year.

However, it is not my dodecagon. I was born in 1941, which makes me a snake.

Monday 1/23, I will get my first Pluvicto infusion at Dana-Farber Boston.

Who can remember the generic name for Pluvicto (vipivotide tetraxetan)?

say that fast 3 times.

Please wish me luck on Monday.

For all cancer patients, caregivers, and healthcare workers,

God Bless Us, Everyone

Tall_Allen profile image
Tall_Allen in reply to TomMaloney

Good luck! Let us know how it goes.

nuc1111 profile image
nuc1111 in reply to TomMaloney

BAT Are there others who would like to share their experience with BAT?

Mrtroxely profile image
Mrtroxely

Hi all.This bat area is a great hope.

This conversation shows this.

There does need to be a devil's advocate.

Also the negatives need be shined as well as positives.

I looked for real life living evedence of people with experience.

There are small percentages of people who get amazing results from this type bat treatment, fact(looks great for us)

There are small percentages who get zero benifit fact (that's ok, no probs)

There were small percentage who had dramatically awful results and accelerated pain and awful quality of life.

1 guy dead withing few months.

But this remains one of my hopes in this area.

So really gratefull to read smurts findings, techniques.

And putting his money where his mouth is...

Thank you all

Awsome

Hopefull

Factual

Informative

And a light in a sometimes gloomy room.

smurtaw profile image
smurtaw in reply to Mrtroxely

Thanks for the thoughts.

I can't think of a therapy that doesn't have risks and BAT too has risks. Do we do ADT until we become CRPC? Do we accept CRPC and try to eek out some more time with what I view as a type of pallative care? Do we go for a cure up front and hope that the side effects don't do us in?

In the meantime, guys like Patrick (14 years) and Paul (4 years) are showing us that BAT can be exceptionally effective.

Some would have us believe that the present BAT incarnation is as good as it gets and none of us can do anything about it. I think that they are incorrect. I think that the risks can be mitigated. I think that the pain risk can be reduced. I think that the therapy itself can be improved. I recently talked to one of the MOs involved in some of the clinical trials and they also thought that a shorter half-life testosterone would improve the results. In an interview, Denmeade admitted this also. There are other ways around the half-life though so if an MO is set on testosterone cypionate, it can work and work well. But not necessarily with one-month static cycles unless an ARB/ARSI is used at the proper time.

The present data hints that BAT synergizes with other SOC therapies. COMBAT was a huge success and the Xtandi resensitization and the improvement in post BAT Xtandi/Zytiga efficacy is amazing. I predict that the coming clinical trials are going to leave many of us wondering why in the world it took so long.

When I started it, libido, muscle, fat, energy, and bone mass played a large role in my decision. I was hoping for 9 months. Now that I am a year and a half down the road, all of my metrics appear to be moving in the right direction, and I am pleasantly shocked to see that, at least so far, I can have my cake and eat it too. My MO does not want me to consider doing anything else at this point (not that I would). My only interest in learning more about BAT and associated therapies and sharing my knowledge is to help others. Unfortunately, I do not sell testosterone...

To anyone considering BAT, please research, please read my book, and please talk to your MO and also to BAT MOs. MOs who practice BAT may or may not give you the full picture. So it is up to us to research it and ultimately take responsibility for what we do.

By the way, my book is free on kindle unlimited. I also posted it on Amazon, and they require a minimum of $2. Of that, I get about 20 cents. Last year I "made" $40. I matched the $40 and rounded up to $100 and donated to a prostate cancer charity. I hope that I lose more this year than I did last year.

Mrtroxely profile image
Mrtroxely in reply to smurtaw

Thank youI feel your energy and fight for something more what's beinf handed to us.

smurtaw profile image
smurtaw in reply to Mrtroxely

Dare I say it... BAT gave me the energy. It's 4AM here and I am up writing.

nuc1111 profile image
nuc1111 in reply to smurtaw

Indeed

nuc1111 profile image
nuc1111 in reply to smurtaw

👍👍👍

gsun profile image
gsun in reply to smurtaw

What is the name of your book?

smurtaw profile image
smurtaw in reply to gsun

I sent you a PM.

Bethishere profile image
BethishereAdministrator in reply to smurtaw

I hope the prostate cancer charity you donated to was Malecare

smurtaw profile image
smurtaw in reply to Bethishere

I donated in 2021 to malecare. Last year I donated to pcf because they had 100% matching when I donated. So, I matched, they matched, 4x my book proceeds. Still only amounted to $200.

nuc1111 profile image
nuc1111 in reply to Mrtroxely

agree-Thanks

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