TRANSFORMER: Bipolar Androgen Therapy vs Enzalutamide in Asymptomatic Men With Castration-Resistant Metastatic Prostate Cancer
"I chose the TRANSFORMER protocol published in JCO in April of this year as my Story of the Year. This paper was selected due to its sort of paradoxical nature and what may be considered unexpected results.
"This was a prospective phase II study wherein men with metastatic castration-resistant prostate cancer (mCRPC) who were asymptomatic and had progressed on abiraterone were randomized to receive testosterone at a dose of 400 mg every 28 days (the bipolar androgen therapy [BAT] group) or enzalutamide. Upon progression, patients received the opposite therapy, and PSA response was again evaluated. There was a 50% PSA reduction in 28.2% of men on BAT therapy compared with 25.5% of men taking enzalutamide. There was similar progression-free survival of 5.7 months in the two arms, and overall survival of 32.9 and 29 months in the BAT arm and enzalutamide arm, respectively. Interestingly, 77.8% of patients who received BAT followed by enzalutamide had a PSA50 response compared with 21.3% among those who received BAT after enzalutamide. The patients who underwent BAT followed by enzalutamide also had an improved progression-free survival response of 28.2 months versus 19.6 months with enzalutamide followed by BAT.
"It is interesting that patients who received BAT prior to enzalutamide seemed to continue to respond or to have renewed response to enzalutamide. This suggests that BAT may “re-sensitize” prostate cancer cells to next-generation hormonal therapies."
What if there were to be a BAT trial limited to men who had been on AR-axis therapies for exactly 12 months? Or 6 months. Who knows how long AR-axis drugs might work with a periodic BAT reset.
I suspect, based on my own use of T for many years now, that a 3-monthly reset, scheduled when ADT is initiated, would extend many lives.
Very happy he is further highlighting this important trial. Maybe it will filter down to more community MO docs.
I'm in this camp also. TRANSFORMER was king in 2021. Research in this area is increasing. I hope for even more effort in hormonal therapies outside of the standard androgen depletion. 4 RCTs have been registered with the government in the last two years. Only 6 were registered prior to these. A new study combines BAT with Radium-223 (BAT-RAD) clinicaltrials.gov/ct2/show... is heartening that work is being done on attempting to integrate BAT with other therapies.
This is on the short list of treatments going forward for me now that I’m castrate resistant. Sartor is my MO and he obviously has a lot of experience with it (he’s one of the docs involved in this trial) and said I’d be a candidate. He said it’s not for everyone and requires a MO who is experienced using it, that there’s a bit of “artistry” involved. He has had some patients with exceptional results that are ongoing - results that far exceed what the findings are in the trial.
My husband did BAT and loved it. PSA went from 30 to 6 before rising to 17 after 10 injections. He is back on Xtandi for almost 2 months and PSA is back down to 10 but he feels like #$%@. After his psa rises on Xtandi he will restart BAT and we can't wait. The difference in EVERYTHING--physical, mental, emotional--was much improved on high T.BAT may only work well in about a third of men who try it but Xtandi only works in about 55% of men.
Greatly appreciate your info, as always. I'm about to change from abiraterone to enzalutamide as the former isn't working. I've forwarded your citations to my MO to see if this might be a good time for me to try BAT. Thanks again!
Thanks Patrick. If there are no studies showing it’s advantage for css then are people using it for qol, or in a belief that it will later prove to extend css?
My hesitance toward BAT done at home is: possibility of extra heart side effect potential, and that doing BAT sound like it’s somewhat time and effort intensive.
Why don’t you ask your doctor to prescribe it or get another pro-BAT doc to prescribe and yours does the injection and consult? The TRANSFORMER protocol is one shot every 4 weeks.I believe 100% of the BAT group reported higher QOL. It is real.
Finally, there are comments on this forum about BAT not extending life but that is not what our oncologist says.
It is interesting that BAT and LU177 have the same basic stats: 1/3 of men do great, 1/3 of men do okay, and 1/3 of men do poorly. LU177 can destroy your bone marrow but everyone wants to try it as soon as it is approved. Yet so many are hesitant to try BAT due to decades of hearing about the evils of testosterone.
Blood tests for T before and 36 hours after the 1st shot, and one at end of 1st month give data to calibrate dose. If there are known heart problems then consult an expert.
I have three cardiologists. I know what they can do and can't do. The first heart treatment given to me caused a dissection and almost killed me on the operating table. Since then, I have studied many ways to prevent heart attacks, much like Nalakrats has done. My Triglycerides to HDL ratio used to be 8-1, even with frequent exercise and fairly healthy eating (according to American government agencies like the FDA - food pyramid etc.) Turns out that recommended pyramid has been responsible for the deaths of tens of millions of people.
Following my own research and taking action, I have my triglyceride to HDL ratio down to 1:1 now. I can't guarantee I won't have a heart attack, but the odds are low because of my adjusted diet, plus, smart exercise. I don't play Ice hockey and basketball games anymore because I couldn't participate at a 70% effort. Didn't want to have a result like Alan Thicke.
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