the phase II BATMAN study.: New study... - Advanced Prostate...

Advanced Prostate Cancer

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the phase II BATMAN study.

pjoshea13 profile image
19 Replies

New study [1] below.

As noted by Paul in response to my "Sex steroid induced apoptosis ..." post, BAT is "Bipolar Androgen Therapy"

"We have previously documented a paradoxical anti-tumor effect when castration-resistant prostate cancer patients were treated with intermittent, high-dose testosterone."

"Because, an adaptive increase in androgen receptor expression following chronic androgen deprivation therapy (ADT) may underlie this effect, we tested whether men with hormone-sensitive (HS) prostate cancer (PC) would also respond to BAT if given following a 6-month ADT lead-in."

"Following 6-month of ADT, those with a PSA <4 ng/ml went on to receive alternating 3-month cycles of BAT and ADT. BAT was administered as intramuscular testosterone (T) cypionate or enanthate 400 mg on Days (D) 1, 29, and 57."

"ADT was continued throughout the study ..."

"The primary endpoint was met, with 17/29 men ... having a PSA <4 ng/ml at 18 months."

...

I have an interest in the study because of my own experiment.

I had a failed RP in 2004, followed by unsuccessful salvage radiation in early 2005. In 2006, concerned about PSA increases & the prospect of ADT, I began using androstenedione to boost testosterone. When my stash was running out (it had been banned in the U.S.), my integrative doc prescribed 5 mg Androderm patches. I was already on Arimidex to control estradiol. Along the way Androderm reduced the maximum dose to 4 mg. As of 1/1/2015 my insurance would not pay for Androderm, so I switched to testosterone cypionate - 80 mg injected every 7 days.

All had been well until 2009-10 when I had an escalation of treatment-related bowel issues, that was unfortunately treated with an antibiotic that was a powerful methyl donor. Disaster.

My PSADT shrunk to < 3 months.

I decided that I would alternate 3 months castrate with 3 months testosterone supplementation.

For me, using 80 mg testosterone cypionate, T is above 1,000 ng/dL on day 8, before the next muscle shot. I don't know what 400 mg would do. But perhaps monthly shots were for the convenience of the study.

My own experiment is ongoing & all I can say is that I am not yet CRPC & I enjoy a good QoL.

While I am hesitant to promote my approach, I was amused to see that BATMAN used the same 3-monthly cycling.

Note that Dr Myers attempts to use IADT to obtain a durable remission. He once said something along the lines of: you only get 2-3 cycles before CRPC. He has also said that the ultimate aim is to restore testosterone.

In the more rapid IADT, with T supplementation, one is aiming for dynamic equilibrium - not remission, but not progression either.

-Patrick

[1] ncbi.nlm.nih.gov/pubmed/273...

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Did you systematically do 3 months on/off, or it depended on PSA levels (how high did they climb, and always the same?), what was (is) your ADT? You have been doing this since 2010? Do you think such a therapy would be possible also without having had operation or radiation? From 2006-2009 how fast was your PSA rising and did testosterone change anything on that?

pjoshea13 profile image
pjoshea13 in reply to

After 3 months on T my PSA was as high as it was before 3 months of ADT, but the 3 month period was not driven by PSA. I could have allowed it to go higher, but it never did.

My PSA doubling time in the 3rd month was ~3 months, but it might have settled into a longer PSADT, if I had extended the T phase - I don't know.

I used Prostasol. It was spiked with something, probably DES. Men had been using it for many years. When the creator of the product was arrested (for an unrelated offence - promoting a supplement as a treatment for another ailment), the product stopped working. Meanwhile, we had all stocked up with the last effective batch (9050). I still have some of this ancient stuff, but I am using DES (1 mg) now.

I see no reason why this type of protocol couldn't be used in an untreated man. Men are usually looking for cures, & this is not a cure. But, for a great percentage of men with serious PCa, the standard treatments are not cures.

in reply topjoshea13

Well, I don't see too much of a cure around.... and with a Gleason 9 extracapsular and maybe mini metastasis. ... they propose ADT + radiation, but my fear is resistance and also CVD issues....

For the moment our approach is more of finding a balance, we don't believe in cures. Just not sure how important it is to remove the bulk.

Our naturopath wanted to give Prostasol, but it is the new version... did you have any side effects with Prostasol ?

pjoshea13 profile image
pjoshea13 in reply to

No side effects at all except some breast sensitivity.

Has the naturopath actually seen benefit in the new Prostasol? Perhaps the unlisted ingredient has been put back? Supposedly, the old product was found to contain DES. Some of the men in the old Prostasol group found ways to get hold of low-dose DES. They regained control mostly using 1 mg. A few only needed 0.5 mg. None of them were using testosterone.

You wrote: "Just not sure how important it is to remove the bulk."

I believe it is very important when the PSA is rising. Not so, when you have it under control with BAT, say. Surgery can be done later, if necessary. IMO

Best, -Patrick

in reply topjoshea13

Yes, my naturopath said he had good results. Looking at the ingredients I think my husband already takes all but Japanese knotweed and in bigger amounts and it is quite expensive. I was also worried with the hormones not stated, but now I understand better.

med-pro.org/en/produkt/pros...

Will check how to get DES, would maybe casodex also be an option for BAT? My concern with DES is CVD.

Also: with 3 month PSADT did you get after ADT the same PSA Base or it raised with time (and how fast).

In my husband's case if his PSA does not continue to go down doubling PSA could be a danger (too high).

pjoshea13 profile image
pjoshea13 in reply to

I should perhaps give you a little history of ProstaSol.

It was created by Dr. Donsbach in the U.S. There was some kind of deal that led to a European product. The U.S. product was made in Mexico. The name sometimes changed, but people knew it as Prostasol (small "s").

The European version was (I believe) the same product for a while, but it came from the Netherlands & it was known as ProstaSol (large "S"). In time, it diverged in terms of the ingredients.

The slight difference in the name is important, but people don't always use the correct version. Here is an English article from way back (2006) [1]:

"In desperation, Faith turned to the internet. Her research led her to Professor Ben Pfeifer, director of clinical research at the renowned Aeskulap Clinic in Switzerland, who specialises in combining conventional and complementary cancer therapies.

She read about Prof Pfeifer's success in treating prostate patients with a phytotherapy (the medicinal use of plants) protocol of four supplements, taken in specifically designed cocktails every day. These were Prostasol, which contains a range of herbs and dietary supplements with proven efficacy in supporting the prostate; Imupros, containing vitamins, trace elements, ginseng, lycopene, and green-tea extract to aid prostate function; Curcumin Complex, an extract of turmeric, which is a potent antioxidant - to mop up cancer-causing free radicals - and an anti-inflammatory; and Biobran, made from Japanese rice bran, which boosts the immune system.

"A one-year clinical study involved 184 patients with advanced and end-stage prostate cancer. In two thirds of patients, their symptoms were relieved, PSA levels were reduced by up to 50 per cent, tumours shrank, and the disease's progression was inhibited. When the trial was extended for five years to include a further 1,250 European men, similar results were obtained.

Faith contacted Prof Pfeifer but her hopes were dashed by the protocol's cost - £500 a month. She found it wasn't available on the NHS. But she was determined not to give up and decided to try to interest British doctors in the study. This led her to Tim Oliver, professor of medical oncology at St Bartholomew's and the Royal London NHS Trust. She bombarded him with facts.

"When I saw the findings of the European research using these supplements, it really interested me," says Prof Oliver. "I was particularly attracted to this protocol because unlike other prostate-cancer treatments, it does not cause impotency.

"Finding a treatment for men who no longer respond to conventional hormone treatment is the holy grail of prostate cancer. There is nothing I can offer these men in the long term; with advanced tumours, the average hormone therapy will last between two and four years."

"Prof Oliver agreed to run a 10-man study in London but first had to obtain the expensive supplements for which he couldn't secure NHS funding. Faith contacted their British distributors - they are mainly formulated in the Netherlands - and persuaded them to donate the drugs to Prof Oliver. She also e-mailed Prof Pfeifer, who agreed to liaise with the London study and advise on Al's case.

This January, Al became the first British patient to start the protocol. Although his PSA was 42, he stopped the Casodex and instead took a mixture of 10 pills every day. He and the other nine men will be monitored by Prof Oliver for up to 18 months.

"At this stage, it is too early to be deemed a trial," says Prof Oliver. "Herbal medicine has been tried before and you have to be careful. A few years ago, another herbal mixture known as PC-SPECS had to be withdrawn because of contamination. But herbs could have a useful place in the treatment of prostate cancer and this study could enable us to validate it in a cost-effective way.

"If I can confirm the Pfeifer findings, I will carry on and do further clinical research which is properly approved and documented."

Within a few days of taking the supplements, Al's urine flow was much stronger with less urgency and frequency and he was sleeping better. After two weeks, his PSA had halved to 21; after a month, it was down to 10; today it is seven.

"I know this is not a cure, but it is an exciting development," says Al. "Hopefully it will continue to improve my quality and quantity of life for a long time to come.""

Ben Pfeifer's involvement with ProstaSol is very interesting. He was an early user & it's tempting to suppose that he was involved in setting up MedPro.

***

Here is the Pfeifer Protocol (2005) [2].

***

Your concern with DES is CVD. At 1 mg, this does not appear to be a problem. However, I do take nattokinase & I do test D-dimer, so I am not worried.

***

The thing about my 3-month 'protocol' is that the testosterone [T] phase could just as easily be 2 months or 1 month. i.e. you could use a T phase where the PSA doesn't have time to recover.

Dr. Denmeade uses a short T phase, but T is high for at least a week of the monthly cycle. He also uses a short castrate phase (I have no idea when injected T is finally cleared). One would have more control with T patches, which are cleared quickly.

-Patrick

[1] telegraph.co.uk/news/health...

[2] pfeifer-protocol.com/2005/1...

in reply topjoshea13

Thanks! Yes, I knew about Pfeifer and also about PC-SPECS, my fear was to take a herbal supplement with estrogens not knowing what was in. But still interested, since I am in Switzerland tried to find more out about Pfeifer. He had also some legal problems in Switzerland because of illegal drugs and taking a lot of money from people.

So I got worried about possibly charlatanism, specially in the situation of a lethal disease where people (me included) want to believe in a cure. I even began to be suspicious about my naturopath, because he sells Prostasol...

But you never know with so many naturopaths having legal problems (and at the same time other doctors giving you horrendous chemotherapies without telling you the truth without any problems...).

I will try to find out more about Pfeifer, his protocol, which is more than Prostasol (but under exclusions, also if less critical, you have Gleason 9-10).

I will keep you updated, if I have more news.

Greetings from Switzerland and thank you so much for always being there.

In this study ADT keeps going, did you do the same or did you stop ADT during off-phase?

pjoshea13 profile image
pjoshea13 in reply to

Yes. With daily oral ADT it is easy to stop quickly.

Continuation of ADT in the study was a convenience. With a monthly cycle & a product that is effective for a month or longer, you might as well keep going. The injected T & some adrenal-related T was the only T that men had, & perhaps it's an advantage having a somewhat level playing field, but I doubt that was a consideration.

-Patrick

How high do you get E2 with DES? Does it raise prolactin?

pjoshea13 profile image
pjoshea13

I have not tested E2 at the end of the DES-BAT month. It should be low, but prolactin was 11.1.

-Patrick

in reply topjoshea13

it is still normal range, so probably not raised by E2 (?). Still thinking if lowering would be a good idea. Since you already take E tocotrienol it does not the job (or not enough). What do you think about vitex? rainbow.coop/library/prolac...

pjoshea13 profile image
pjoshea13 in reply to

I haven't come across vitex as a topic for maybe a dozen years. The berry is also called monk's pepper - supposedly used by monks to control their physical desires. It does this by lowering testosterone. I was in a small group where men were against castration as the automatic treatment for PCa, so there wasn't much interest.

But I need to look into it further. Hardly a mainstream supplement for men with PCa, I suppose. Thanks for mentioning it.

-Patrick

in reply topjoshea13

sci-hub.tw/10.1055/s-2005-8...

sci-hub.tw/10.1111/jfbc.12902

Break60 profile image
Break60

Patrick

I’m confused. Why use BAT if you’re castrate sensitive , Psa is under control , and estradiol patches work without CV events and other lhrh side effects?

Bob

pjoshea13 profile image
pjoshea13 in reply toBreak60

Bob,

I feel it is important to prevent the adaptation process that leads to CRPC. The adaptation is to very low androgen levels. So a periodic boost of testosterone perhaps resets the clock. Basic ADT fails in 18-24 months for most men. Modern treatments (basic ADT plus newer drugs) extends the sensitivity period somewhat. But what if someone is thinking of 10 years or longer? Modern protocols do not deliver that. You will read from the exceptions here, but they do not disprove what I have written above.

-Patrick

Break60 profile image
Break60 in reply topjoshea13

Dr Wassersug says he’s been on the patches for 15 years! I’ve been sensitive for five years. Just started the patches in January. Hope to ride them as long as possible. I switched to reduce side effects of lhrh agonists but they were still working. I wonder if the time comes when I need to add Zytiga if I would be able to stay on patches or would I have to go back on lhrh a?

pjoshea13 profile image
pjoshea13 in reply toBreak60

I'm sure that Richard is just as grateful as I am to have survived 15 years. We have left a lot of men behind. As for E2 patches, I'm waiting for the PATCHES report:

clinicaltrials.gov/ct2/show...

-Patrick

Break60 profile image
Break60 in reply topjoshea13

I decided not to wait.

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