Trying a high dose testosterone clini... - Advanced Prostate...

Advanced Prostate Cancer
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Trying a high dose testosterone clinical trial

Zytiga has failed me and my PSA is taking off again. Instead of rolling to the next ‘standard of care’ I opted to participate in a high dose testosterone clinical trial. I started 3-weeks ago. Here is info on the trial ( clinicaltrials.gov/ct2/show... ). It is an evolution of the bi-polar trial discussed in this pub ( ncbi.nlm.nih.gov/pmc/articl... ). Hopefully this will yield some good results- but regardless after 3 years on ADT, having my T over 1000 now feels great!! I’ll keep you posted if it works or fails.

Keeping the Dragon in the Cave!!!!

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As a guy with no T for 31/2 yrs I’m interested in this trial you’ve joined. Hope for us all .. I’m pulling for good news.......Great luck ...

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I understand that some guys who had failed all the ADT drugs have done well with this opposite therapy. It's a cool idea. First kill off all the tumor cells that need androgens. A lot of the remaining androgen independent ones are now probably conditioned to not like androgen. So whack them from the other side with lots of androgen. Then go back and forth.

I really hope it works well for you. Please do keep us informed.

Alan

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A bit different from Sam Denmeade's BAT, which is continuous Lupron + a monthly shot of T cypionate.

You alternate between "2 packets of testosterone gel 1% containing 50mg per packet to apply transdermally daily" & "four 40mg capsules of enzalutamide for a total daily dose of 160mg". It's not entirely clear to me what the cycle is.

"The mean terminal half-life (t1/2) for enzalutamide in patients after a single oral dose is 5.8 days (range 2.8 to 10.2 days). Following a single 160 mg oral dose of enzalutamide in healthy volunteers, the mean terminal t1/2 for N-desmethyl enzalutamide is approximately 7.8 to 8.6 days." [1]

"There is considerable variation in the half-life of testosterone concentration as reported in the literature, ranging from 10 to 100 minutes." "When AndroGel 1.62% treatment is discontinued, serum testosterone concentrations return to approximately baseline concentrations within 48-72 hours after administration of the last dose." [2]

I think I know what "Square Wave Testosterone Therapy" is supposed to be - {"It has been hypothesized that the transdermal formulation will ... allow for a steady state of elevated testosterone, rather than the peaks and troughs seen with the IM approach." [3]} - but I'm struggling with the half-life info.

-Patrick

[1] accessdata.fda.gov/drugsatf...

[2] rxlist.com/androgel-162-dru...

[3] library.ajman.ac.ae/eds/det...

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So I do 2 packs of gel each morning only. If there is no additional progression, based on radiology, then I just stay on the gel everyday. I also stay on Lupron, so I can shut off the T quick if I get progression by just stopping the gel. I would switch to enzalutamide (standard of care) only if there is progression. I think there is may be group taking the T and Enz together. I’ll keep you all posted

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I am also confused. If you are on Lupron ( typically long-term T production suppressor), how would the T patch do any good in raising T to high level above 2x-3x normal?

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The Lupron just shuts off the body’s PRODUCTION of T it does not affect T that is in ones system. So adding T through the gel is not affected

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As per Patrick's analysis --I agree, the half life's do not make sense. But I am glad for you. You are at least doing something, that at this time avoids the Chemo. Please keep us posted. Patrick and I would be very interested as we both follow High T protocols.

Nalakrats

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Hmmm you guys ask some good questions- I’ll study this and check in with the research team next week and then hopefully follow up with an answer that clarifies.

I do know the intent is to get my T high and keep it high (in the 1000-1200 range) with no dips

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Thank you for sharing this info and keep fighting. Very interested in follow up for us with mCRPC. One question though: The clinical trial section called “Exclusions” said something about previous exposure to “second generation antiandrogen” . Why are you not excluded? Can you explain? I suspect tat most of us at mCRPC stage have at one time or another been exposed to second generation AR such as enzalutamide (Xtandi), abiraterone (Zytiga), or apalutamide (Erleada). Thanks.

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I’ll ask at my check up this week and get back with you

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I receive a horrible responce to my suggestions of high T.

Should I move on to a new oncologist and how do I find such a person. Thanks. Ted

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I’m not a doctor, but from my understanding it depends on the individual if they would be eligible. With the trial I am on, I would not be eligible if I had mets. to my spine.

But, this is also a paradigm shift for med oncologists dealing with PC, if your Onc is late career and not associated with a research unit or not watching the current research, then it may be good to shop around. I’m an advocate for getting multiple opinions - our lives are on the line.

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Thanks . I have a appointment with an oncologist to do T patches.

Did trial called ESK981. psa went to 700.

Freightened.

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