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?
BAT is experimental and can be quite dangerous and is never given to symptomatic patients.
There was a trial combining BAT and olaparib in 30 men who had progressed on Zytiga or Xtandi. Half had DNA damage repair defects.
• ¾ had at least some PSA reduction
• 47% had a PSA reduction ≥ 50% (44% if 2 who dropped out for progression are added)
• 23% had a 12-wk PSA increase ≥50% (28% if 2 who dropped out for progression are added)
• Median progression-free survival was 14.8 months if they were mutation-free vs. 7.5 months if they had the defects.
• 2 patients had a complete PSA response
• 5 of 8 90+% responders were free of DNA damage repair defects
• 3 of 6 90+% progressors had DNA damage repair defects
• 5 patients had serious (grade ≥ 3) toxicity, including one death
The cause of responder/non-responder differences remains elusive.
urotoday.com/conference-hig...
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.
That's a very rational response.
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.
I would get multiple second opinions from docs that actually practice bat.
I would include Dr. Sartor at Tulane.
The Dr. Morgantaler last in-house clinical trial he ran was most interesting. I do not know how the men selected were chosen. Dr. Morgantaler ran this in-house trial out of His Boston's Men's Health Clinic. I understand and I may be wrong, that he chose men who had very little time left, and that some were already in discussions with their Local Hospice. I heard they were looking at 6 months to 12 months left. But who can predict? They all had to sign waivers that the procedure had a high probability of causing further Physical harm and Death.
As to the trial that I do not believe he published, there were 23 men selected. 2 died of Heart Attacks, 3 dropped out due to side effects they could not stand, and 18 were still alive 4 years later. They may have passed by now, but those 18 got a lot of days of life.
And you are right Dr. Morgantaler used 400 mg injections every 2 weeks for 2 months and then stopped and in the 3rd month he used full dose Xtandi. And then repeated the 90 cycle. I believe he reached levels of from 2000 ng/dl to 2,200 of Total Testosterone.
It is interesting to note that soon after Dr. Denmeade in a new trial, who's name I do not remember, has decided he had to go longer than one month with Testosterone Cyprionate, to 2 months, and that he will use Xtandi, as his ADT.
I have been following this as a Girlfriend who Posts here, got a connection with a Doctor in I think Emory, and is doing some form of BAT.
As a side note: You can contact Dr. Morgantaler even though he is retired and he does consults. I do not know how to contact him, and I hear that his consults are very expensive.
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.
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?
Almost none of your t was available and probably bound to your SHBG. I think the minimum in the range of Free Testosterone is 47, and you are showing 2.3. You probably have more active Estrogen than Testosterone.
so I wonder where the science is on the guys hoping to get testosterone back enough to have some energy yet not wake the cancer up.
All very interesting.
I hope you do a page on your blog on this subject when the fog of war clears.