I'm mCRPC with node involvement, extensive bone mets, and recent liver mets.
I was diagnosed with mHSPC (bone and node) in June 2021, I progressed on Lupron/Zytiga with 6 cycles of docetaxel (PEACE1 triple therapy protocol) in October 2022. I dId Provenge at time of progression and am currently on olaparib/Lupron/Zometa. I'm responding well but I'm curious about BAT and in particular Dr. Morgentaler's mBAT (four 2-week cycles of testosterone followed by four weeks of Xtandi). Has anyone here had experience with this protocol? Is it something I should consider now, or should I wait for progression on olaparib?
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Djangler
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Thanks TA. I've read a good bit of the literature on BAT. I understand the dearth of RCT data on this treatment. I'm not symptomatic, and in fact, I feel quite well and have tolerated my other treatments with minimal AE. My MO is willing to consider BAT as part of my treatment plan, but we haven't discussed exactly where it fits.
I've requested a consult with a doctor he knows at Johns Hopkins. I want to understand the risk/benefit. In particular, I haven't seen a lot of discussion about what happens to the roughly 1/3 of patients that discontinue BAT due to poor response (exponential PSA rise). Would trying this cut months off my already short OS prognosis?
I have BRCA2 and TP53 variants, but not RB1 or PTEN. There's some indication that these variants are markers for improved response, but as you say, this is far from established. There's also some evidence that BAT increases successful rechallenge on NHT - again, the evidence is more than anecdotal, but less than conclusive. One thing to consider, mCRPC with visceral mets is already quite dangerous - in fact, it's about as close to guaranteed fatal as you can get. If BAT buys me some extra good months I'm willing to consider it, but I want to understand the risks before I decide.
Regarding the roughly 1/3 of patients that discontinue BAT due to poor response (exponential PSA rise): Denmeade has noted that the high-T itself can promote an increase in PSA without that increase necessarily indicating a PC progression as severe as suspected... possibly, in some men, PSA will rise without ANY radiographic indication of worsening disease.
You are absolutely right to question the impact on OS... that is what counts, after all, and not the PSA number. I also hope to pursue BAT as a "roll of the dice" because at the very least, even if the high-T fails to temporarily slow progression or even if it promotes progression, I expect the QoL boost may be worth it. For some, losing a few months of OS may be a fair trade-off for gaining some higher QoL as one approached the end of life. (We are incurable, after all.)
I tend to see Pluvicto as being great for about 1/3 of men, inconsequential for 1/3, and perhaps ultimately harmful for 1/3. I tend to think of BAT as having a similar distribution, in very rough terms. One difference? While it appears Pluvicto helped me to become quite anemic, I see a possibility of BAT helping me become LESS anemic (since high-T is known to help some men in that regard).
Another difference of course is that one therapy costs $40k per dose and the other costs just $40 per dose, lol.
Boy that would be a great treatment. I asked my doctor about high testosterone as a treatment and I’m glad we were in a chat instead of a visit. I swear I saw a smile in his hell no reply to me. However he has indicated in the past that low testosterone may be related to prostate cancer. Obviously no clear answers but he has pushed me to get mine above 300 and my tumor was way out of the bag and may have invaded my rectum.
I’m wondering the difference between testosterone tests. My normal testosterone is 264 this month and I had a free testosterone test for the first time of 2.3. 264 kind of up in the green and 2.3 way down. How are they related?
It has its limitations and require a correct selection of the patients, but it can be done out of a study,.
Dr. Denmeade:
"Again, based on enough experience, now we've treated several hundred patients that I feel like those patients who have access to this, who want to try it. But again, making sure their physicians understand these issues about pain and other limitations of the treatment, like the right stage of the disease, et cetera.
So yeah, it's an easy thing to do. The testosterone is very inexpensive. It probably costs $20 a shot, so it's very inexpensive. So patients, even if their insurance won't pay for it, can try it. And sometimes patients write us back and tell us they've had great experience, and that's hope. For now though, I've been trying to do the best I can to educate everybody about making sure it's the right group, the right timing, and the right symptom complex.
Clearly, this is a therapy for a certain stage of the disease. So, patients who have not had any hormonal treatment, probably the opposite would happen. If we gave testosterone, we might even make it worse. So, certainly in patients who haven't had local treatment for prostate cancer, it's not the right thing, or who haven't had hormonal treatment yet, hormone lowering treatment. We think there's the stage of the disease where this is appropriate, and those are the patients we focused on in all of our trials.
We've also found patients who have a lot of symptoms from prostate cancer, particularly pain, this is probably not a good idea. Because, when we first give the testosterone, people can have what we call a flare where the disease could not necessarily grow but make factors that can make pain worse. So, we found that in guys who have pain already, few guys that we treated, the pain gets a lot worse. People that don't have any pain seem to do fine, and that's the majority of the patients we've treated. But clearly, I get asked a lot of questions from people around the world, that's really the place that this is for patients who've become resistant to their primary hormone therapy, their second hormone therapy that we use, that's the group we look at."
Thanks, I watched that the other day. I'll be talking with a different doc at JH to see if BAT is appropriate in my specific case. The reason I posted this question was to see if anyone has experience with Dr. Morgentaler's mBAT protocol.
Yes. The P53 is one of two things that excite me about BAT. As far as I know, it's the only treatment where P53 is an asset instead of a liability. The other thing is resensitivation to NHT drugs. I progressed on abiraterone, but I'm hoping for response to enzalutamide if I do BAT.Of course, it also might be nice to have some testosterone back in my system for a while. ADT hasn't been awful, but there are things I miss from before 😉.
As far as I know, Dr. Morgentaler's data is entirely from case studies of his patients. No trials that I'm aware of.
I believe Dr. M's mBAT patients were just a handful of men representing something like a small-group case study rather than anything like an RCT. Because he is retired, I suspect there are very few men who have tried his protocol, and even fewer docs willing to prescribe it since it does not have the RCT protocols of the Johns Hopkins trials.
As for trying BAT sooner vs. later, it is important to consider that if you progress to the point of having painful mets then you run the risk of being denied that treatment, since Denmeade has mentioned he excludes those men (as well as those who are still hormone sensitive).
On the other hand, who wants to give up a therapy that still appears to be working well?
That's great. You are certainly an outlier as far as those attempting BAT, by not being either in a trial or following trial protocols, but I think your success is inspiring for those considering any form of BAT whether self-designed/directed or not. I think I have found an MO willing to go the Denmeade route with me, and it's pretty exciting. (Of course, so was the chance to be in a Lu177 trial, which did not work out so well for me... but ya gotta keep rolling those dice.)
I also think it's great that you gave yourself 6+ months to gauge progress. I don't want to dismiss the so-called "dangers" of BAT, but for others who are more cautious doesn't it seem simple enough to just stop it after several months if it appears to not be working? Even if there is PC progression in those months I have a hard time believing there would be a huge impact on OS. One also gets a QoL boost and a possibility of being resensitized to AR agents. A risk worth taking, in my view.
In my reply to Djangler I was referring to "mBAT" in the context of Morgentaler's version of it (let's call that "MmBAT"). Yours is a bit different, and it would be interesting to see a compilation and comparison of your case study and Morgentaler's case studies and any other individual attempts that differ from "conventional" BAT. A new project for you!
Interesting. I assume these charts are from a model you've developed rather than experimental data. If you're willing to share, I wouldn't mind seeing your source code. I'm assuming this includes continuous ADT along with testosterone/Xtandi.
I believe Dr. M's protocol is testosterone on 1, 14, 28, 42 and Xtandi on 56-90. He saw a slowly rising PSA nadir on each cycle. Do you see that with your protocol?
Quick question, does your insurance cover Xtandi used in tbis non-SoC treatment plan? I got a shock last year when I found out my prescription plan only covers olaparib at 70%. Fortunately there's a manageable out-of-pocket cap.
That would be great if you could do that. Just got back from a trip to Minneapolis to consult with Dr. Emmanuel Antonarakis, Luckily I appear to be in the “sweet spot” for starting BAT. Doing it off study with PP overseeing, So there is some room for improvisation. I have BRCA2 germline mutation, asymptomatic, PSA 2.1, just becoming resistant to second line Zytiga. On Orgovyx.
Thanks for the info. Interesting that Dr. Denmeade is shifting to 2 mo. on 1 mo. off with enzalutamide ADT. My MO is open to BAT, but I don't know if he's onboard for this newer protocol. My current prognosis is <12 months so maybe he'll let me drive on this decision.
My MO referred me to Dr. Paller at JH to discuss BAT. She didn't have an open slot that worked for me so I'll be meeting with Dr. Denmeade. I'll ask him about this.
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VISION trial confusion. 
.5, .8, 1.0, 1.3 - Stay the Course?
Next steps?
Gleason score without prostate biopsy
Vacation of treatment
