Bipolar Androgen Therapy -- BAT

I've been quite intrigued reading about Phase 2 results that have trickled out in the past couple of years regarding bipolar androgen therapy. The idea is to give a high dose of testosterone. It's counter-intuitive but the logic is, I gather, the cancer has adapted to a low testosterone environment and blasting it with testosterone kills some of the cancer cells.

Even if it doesn't help it would be nice to feel good for a time. And if my PSA goes up we stop.

Anyone know any more or have personal experience with this technique?

It has interest and merit, just not much in the way of long term results yet. This was never possible until we understood testosterone saturation theory which hasn't been around very long.

BAT is in a way an extension of what some call the triple play of combining ADT, external beam radiation and brachytherapy. Many oncologists have long posited that by combining different therapies at the same time it is more damaging and overwhelming to the cancer than using them in some sequence. After all, that is what chemotherapy has evolved into. Most often chemotherapy is a cocktail of several different drugs, except for PCa that generally uses one.

So BAT is designed to alternatively starve then overfeed then starve then overfeed, and so on, the cancer creating an environment that limits the growth, weakens the cells and kills some that otherwise would survive. I think it makes sense but don't remember anyone on the forum that is actually pursuing the method.

It’s not clear to me that any MO would actually prescribe this treatment until there is clear evidence of benefit from clinical trials.

mattamx said...
It’s not clear to me that any MO would actually prescribe this treatment until there is clear evidence of benefit from clinical trials.

My feeling about that is "if you would do in a clinical trial why can't you do it to me. I will give informed consent just like the people in the trial"

It's my life. For day-to-day practice I would expect "best medical practice" appropriate. But best medical practice is based on Phase III trials. Given that we're in the world of unknown about how many of these meds will work earlier, or would that make it worse. However, if a patient does a lot of reading and clearly understands the risks I see no reason why an MO should deprive me of the treatment path I have chosen. He doesn't know if it will help or hurt, but I'm the one rolling the dice.

My good friend, a retired cardiologist, told me: Patients that are pains in the ass, i.e. those that read up, and take an active role in their treatment, get better outcomes.

Dr's are not bound to follow "best medical practice", though it's certainly the safest course for the physician. You often hear about medications being prescribed that are "off label" -- meaning the med is FDA approved but not necessarily what you're prescribing it for.

To the extent there are "rules", for all practical purposes they're set by the insurance company. Best medical practice is often driven by reimbursement. Unless you're ready to start shelling out six figures a year if it's not covered it's academic. With BAT I figure "how much can a testosterone shot cost?"

Doctors do have to follow rules for "standards of care," medical ethics, their oath, standards of the hospital they work at, insurance requirements and keep one step ahead of malpractice lawsuits. Endorsing, recommending, or administering an experimental treatment (not FDA approved or way out of the bounds of standards of care) puts a doctor at risk for lawsuits, and any number of bad things unless it's under the umbrella of a clinical trail.

Being a doctor is complicated.

clinical trails are more complex then a patient giving consent. Not everyone gets to participate.

That is fascinating --I didn't know about it. I do note that one of the requirements is that all approved treatment option have been exhausted.

I did have general conversation with my MO early in treatment and he agreed in principle to consider prescribing FDA approved medications even if outside the bounds of "Best Medical Practice" based upon informed consent. In my case I wanted access to meds approved for mCRPC even though I am still castrate sensitive.

I've received Provenge. I'm on Abiraterone (now approved for mCSPC, but not when he agreed). He said he would prescribe Enzalutamide if I wanted it instead. He has agreed to precribe Xofigo if I want, though he counseled against it and I followed his advice.

I've gotten a prostatectomy, though not approved for metastatic cases. I'm having my metastases radiated.

So many drugs and treatments have been approved since 2010 but almost all are for mCRPC. The reason for that is that's what Phase III trials were done on. In the fullness of time Phase III results will come out for mCSPC. I can't wait.

He was resistant at first. His answer to most questions was "We don't know". I think the argument that finally won him over was: "I know you don't know if these meds will help me; I understand they may hurt me; I know you don't know which med to give or what order to give them in. Having said that: I've done a lot of reading and I'd rather take my chances with your best guess". One thing that's clear, as pointed out to me by an ONC at NIH, is that the physician needs to now that our consent is truly informed. He then noted that he had spoken to me enough that he was comfortable my consent was truly informed.

It's our lives we're rolling the dice with. Fortunately for me I'm near NYC. There are a lot of fine Dr's there. If the one I'm going to will not consider meds unless they've passed phase III there are plenty of other fine Dr's who will.

Well, I started this and promised to report back. My onc wouldn't do it -- he referred me to Antonarkis at John's Hopkins. I see Antonarkis does a number of BAT Clincal trials. I did ask: "isn't there any one in New York that does this?" None that he knew of.

Separately, Fairwind's post says: "BAT is ONLY recommended for advanced patients who have been on Lupron or a similar drug until it stops working. It's at that point that the cancer cells are vulnerable to a big jolt of testosterone."

Agreed. But is there a reason not do it earlier? I don't know any data. They're always doing clinical trials on castrate resistant people. So, for those of us who are fortunate enough to still be castrate sensitive we're just supposed to wait around and get sicker and then some treatments become available. Underlying reason: Phase III trial was on castrate resistant. Generally if you ask "might it be better is given earlier" you get "we don't know".

Docetaxel came into use in 2004. It wasn't until 11 years later that they discovered that giving Docetaxel up front instead of sequentially with AD got a year more of survival. That's big. A couple of years ago they discover similar results with Zytiga.

All the stuff I read had positive results with BAT. I didn't see one bad one. So, any real reason to withhold it earlier? Besides: I'd like a little testosterone before I die.

This is very interesting.

Thanks for reporting back ANB.

Please keep us posted on your next move, and what you find out.

Thanks for keeping us in the loop. I think this therapy is of high interest to a lot of guys here. I’m hoping some great results from it.

Good luck!

ANB here reporting back. With great effort I was able to get BAT even though I'm castrate sensitive. I've only had one shot so far; next one tomorrow. So, no report on efficacy. But I am pleased to report on "side effects".

Side effects are great. I didn't realize just how fogged out my brain was on ADT. BAT didn't "give" me energy; it put me back in a state more akin to where I was before this mess started. Several friends commented that I seemed back to my old self, including some based only on phone calls.
I didn't feel "great"; I felt normal.

The other interesting thing is muscles. I work out just to prevent muscle atrophy from ADT. I find I can't move up on the weights I'm pushing, but at least I'm hanging on to what I have. The third workout after the BAT shot I was stronger!

It was not easy to get someone to do it, as I'm castrate sensitive and it's still in trials on mCRPC. I read a lot and was able to explain why, based on the information available from Phase II trials, I thought it was far more likely to help me that hurt me. This relates to one of my pet peeves. Virtually all trials are on castrate resistant. Those of us who are castrate sensitive and had standard therapies (ADT, Docetaxel, now Abiraterone) are just supposed to sit around and wait for the disease to advance before getting further treatment?! Makes no sense.

I have argued that it is almost certain that some treatments now reserved for mCRCP would work better if given earlier, as was discovered with docetaxel and abiraterone. Dr's agree. I point out I will be dead by the time that works through the system. They agree. I say "I've got to play the probabilities", meaning take the information available and if it appears, say, there's at least an 80% chance it will help and 20% it won't (or, worse, harm me) do your best. It will likely increase my survival. In addition to reading threads like healingwell I have spent hundreds of hours reading medical journals. I am a Very Informed patient. Why, I ask, will you give a treatment in a Clinical Trial based on IC but not to me when my consent is probably more Informed that most of the people in the trial you're doing. The argument usually doesn't move them.

After making this argument to a brilliant creative up and coming ONC in NYC he still resisted. I then talked about "side effects" and how they would improve QOL. That did it. He said that the known QOL of BAT, along with my other arguments, put him over the top. If it helps, great. If it hurts, unlikely but bad. If it does nothing it's a huge win.

I'll get scanned in two months and report efficacy. They can't measure efficacy by PSA change since Abiraterone knocked my PSA to undetectable.

Next shot is tomorrow. The Dr. mentioned Lu 177 and said he knew some people in Heidelberg who might do it. Even in Germany, where Lu 177 is approved (for mCRPC of course) they're not yet 100% on board with giving it to a castrate sensitive patient but might be convinced. I'm thinking of just one treatment, given the adverse effects on salivary glands. It's not like a drug where the cancer will develop resistant (or at least I don't think so).

The real future at this time seems to me to be Actinium 255. However it really blows out salivary glands, permanently. So that's wait and see, not to mention that I don't know if I could get it anyway.

There are a few guys, unable to get any professional to administer BAT, have resorted to D.I.Y. BAT.....That's right, they obtain the drug on the grey / black market and administer it themselves. They figure the reward is worth the risk.. How this affects their relationship with their primary treatment doctors is anybody's guess..I should mention, as a side benefit to BAT, even if it does not produce a big drop in PSA, is that it almost always re-sensitizes patients to Zytiga and they get another nice remission off that treatment.. Something to do with the A-R receptors being restored....

The reason clinical trials are slow in coming is that Big Pharma sees no profit in developing a treatment that uses an inexpensive generic drug. So what few trials there are are sponsored by a handful of university research labs that tend to move slowly as there is no payday for them either..