I was re-reading Dr. Denmeade's BAT Patient Guide (well worth checking out) and came across the following quote near the end. Thus far, Denmeade seems to have done his own, smaller trials.
"A larger randomized
study comparing overall patient survival following treatment with
sequential BAT → Xtandi versus enzalutamide or chemotherapy
alone will be required to obtain FDA approval of this approach.
Funding such a large expensive trial will be difficult given that BAT is
a generic therapy with no pharmaceutical sponsor supporting its
development."
Of course, that's a somewhat similar comment that alternative medicine proponents make in trying to explain why alternative things will never be approved for cancer therapy.
Of course, Denmeade is at a prominent institution, so this may be different. I believe the guide was published in 2021. Is anyone aware of further developments as to BAT gaining more official approval. I've only recently begun to explore BAT, primarily by contacting Denmeade and Sartor and lobbying my MO to read up on it, even bringing him the guide and other articles.
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dhccpa
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Thanks. I'm at a critical juncture. 5 years on just Lupron, no other treatment. I'm reading more about them starting BAT earlier and getting good results for future treatment.
I'm trying to find a doctor in northeast Florida who's willing to at least consider it. My current MO didn't brush it off, but he gave me that frightened look when I handed him the guide and my correspondence with Denmeade! All kidding aside, I'm not sure if his institution will allow it at this point.
Initially my MO reacted the same way. I went forward on my own, sort of. I did ask him to submit Quest blood tests which he did. I have captured all my data on a pdf for future reference. He is now very active along with me. In fact he recently wrote a script for Nubeqa for me.
My MO has come on board, but I'm navigating. He is included but has not offered any differing suggestions to date. I communicate with Denmeade but not directly under his care.
The problem is it causes harm so often. Like many other therapies (e.g., PARP inhibitors), it benefits a small percentage of patients, and may harm many patients. They are getting a better handle as to how to choose patients that may benefit, but the tests are expensive and only available at Johns Hopkins, as far as I know.
SPECTRA was registered two months ago. STEP-UP could be therapy changing. ExBAT is an excellent protocol. Nineteen clinical trials are completed or in progress.
There is active interest and ongoing research in this area. One of the challenges is to determine who is likely to have a therapeutic response. Progress is being made in this area.
Various BAT protocols are being tested as well as various combination therapies. Rad-223, olaparib, nivolumab, Xtandi, Nubeqa, docetaxel. Other treatments are being considered as well. Pharmaceutical companies are coming on-board with funding. One of the trials used Androgel. Another one is using oral testosterone undecanoate.
BATMAN was a small clinical trial of HSPC men using BAT. A large HSPC trial is being considered. BAT/HSPC funding is an issue.
TRANSFORMER and RESTORE are important. Some MOs have started to direct their patients to do BAT. Some patients are asking their MOs to oversee BAT. They are usually successful. Some MOs understand the QoL benefits and sequential therapy opportunities.
Denmeade is instrumental. I strongly recommend a consultation with him. Denmesa@jhmi.edu
This isn't a trial but has some good information and references. Titration of Androgen Signaling: How Basic Studies Have Informed Clinical Trials Using High-Dose Testosterone Therapy in Castrate-Resistant Prostate Cancer - ncbi.nlm.nih.gov/pmc/articl...
me<---------bites tongue. "Snap-on-tools" I better not go there........(old joke I knew long before both of you were born, but I bet the boss heard it thousands of times)...............
So it's a box of gingersnaps in the mail for your Halloween treat...
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