Couple things .. Excellent results for you Keith...I've read every article and followed your story since beginning..I've also been on another site and lots of guys have been doing these patches successfully...Lack of short and long-term side effects beyond cancer...The video of Dr Shellmemer(sp) there is a section where he was asked how he has lived so long and adapted and his answer was when he went on/changed to Estradiol...He has had an outstanding run and I know you will to...PS...perfect setup for your adaptive ideas .🏋️
I'm doing some volunteer research work for the Estradiol Initiative (E2-I). I'm just getting my feet wet. Thanks for your references regarding NCCN, FDA, and off label use of drugs. I also appreciate your references to historical NCCN documents.
I'm presently interested in how to repurpose tE2, i.e. get an update to the dose and indication for tE2 by the FDA and Health Canada. I heard that E2-I experienced the problem that there is no financial incentive for either generic or brand name holders to participate in prodding the FDA or Health Canada.
I figure, there must be a way forward. I see some promising leads. The FDA has initiated a Drug Repurposing initiative. NCATS has started their Repurposing Generic Drugs program. Although these seem to be moving very slowly, many seem to believe progress will now be much faster than the former pace of imperceptible. There are organizations who claim they exist to help people or groups who want to repurpose drugs, i.e. Every Cure, REMEDi4ALL, and more I'm just starting to find out about. I want to hear from anyone with experience getting FDA or Health Canada approvals.
By the way, I've heard discussion that a low dose of tE2, something around the dose a woman would take for HRT, added to whatever LHRH agonist a patient is taking can help with the LHRH agonist side effects. They were calling it add-back tE2. Doing this seems to appeal to some patients who at present are reluctant about high dose tE2 for whatever reason. As for me, I want to experience life as a PCa survivor without Orgovyx at all. YMMV.
Thanks, David! I did some digging, and I don’t see a program at Health Canada comparable to the FDA’s Drug Repurposing Initiative. REMEDi4ALL is EU-based, so I'm not sure how helpful they would be for the US and Canada. I think your best place to start is the NIH-sponsored Repurposing Generic (ReGen) Drugs Evidence Package Challenge. The team leader submitting the application must be a US citizen (Dr. Schellhammer?), and SURF, E2-I's non-profit, could act as the legal applicant and receive the prize funds. E2-I would provide project leadership and evidence synthesis. But that only gives an organization money to pursue FDA approval. There would still be a lot of work after receiving one of the prizes. I’ll send you a separate message with details.
Based on the evidence available today, I think the strongest initial case for FDA approval would be transdermal estradiol as androgen deprivation therapy for men with locally advanced, nonmetastatic castration-sensitive prostate cancer, since that is the population supported by the recently published PATCH phase 3 data. In my opinion, pursuing a broader prostate-cancer indication before the metastatic PATCH results are available would have a much lower chance of success. Attempting to bundle additional indications into the same initial application would likely weaken the regulatory case by moving beyond the population with the strongest phase 3 evidence.
Another fascinating study and report, Keith. Thanks for sharing this info. A friend whose PCa has metastasized to his bones is currently on conventional ADT, and he reports that the hot flashes can be unbearable at times. I'll have to tell him about your experience.
For me, I glommed immediately onto your discussion of DES. I was a DES baby. After two miscarriages, my mom's doctor prescribed DES to allow me to develop fully to term. It worked (obviously) but I've always wondered how that therapy affected my own development. (There are studies of female DES babies, but none for males that I know of.) Gynecomastia was my biggest issue as a kid, and it's still something I deal with (although surgery 30 years ago helped). Mom even thought that the DES might have made me gay. I told her that was a benefit, not a drawback. (Smile) Today, I still feel like my hormones aren't typical for a man. My PCa was fully contained, and post-surgery my PSA remains undetectable. I am not on any type of ADT. But my testosterone level is always at the bottom of normal (last test 282) while my estradiol is at the top of normal for males (39.2). Perhaps that will benefit me in the long term!
Sending lots of positive thoughts and hopes to you that this treatment continues to benefit your long term health! Hugs.
Hi Steve. I'm so sorry to hear about your and your mom's experience with DES. I only touched on one controversy about DES because the article was so long. It is unfortunately a notorious drug for many other reasons, including increased cancer risks for mothers who took it and their daughters. Thanks so much for the well wishes. I truly appreciate that.
It's probably easy for me to blame DES for some of my health issues, and without any studies on males whose mothers got DES during pregnancy, I'll never know if there's a correlation. But it's also good to know more of the history, so thanks again.
I'm following your journey here and I'm really happy for you!
If you have time for questions: can estradiol be used after Taxotere? Also can estradiol be used in the form of a 2mg tablet, instead of transdermally? Thank you
Hi Noa. I personally would never take oral estrogen at any dose due to the increased risk of blood clots and cardiovascular events. As far as tE2 after Taxotere, one of the studies I referenced showed men responding to tE2 after chemo -> https://pubmed.ncbi.nlm.nih.gov/22460098/ So run that small study by your oncologist.
I don't see why not. Some men with CRPC have had responses to tE2 after heavily treated with other drugs. I'm sorry your Dad and you're family are going through this. Maybe a second opinion with another oncologist. Just a thought.
What an excellent post! I had 6 months of ADT last year and experienced frequent hot flashes, muscle loss, osteopenia, metabolic changes. If only I had known about the patches. My urologist is almost certainly not familiar with these findings. This is a good starting point for future discussion.
Couple things .. Excellent results for you Keith...I've read every article and followed your story since beginning..I've also been on another site and lots of guys have been doing these patches successfully...Lack of short and long-term side effects beyond cancer...The video of Dr Shellmemer(sp) there is a section where he was asked how he has lived so long and adapted and his answer was when he went on/changed to Estradiol...He has had an outstanding run and I know you will to...PS...perfect setup for your adaptive ideas .🏋️
Thanks Jim! Yes, his story is fascinating.
Wow!! Thank you for sharing
I'm studying your article. It is excellent.
I'm doing some volunteer research work for the Estradiol Initiative (E2-I). I'm just getting my feet wet. Thanks for your references regarding NCCN, FDA, and off label use of drugs. I also appreciate your references to historical NCCN documents.
I'm presently interested in how to repurpose tE2, i.e. get an update to the dose and indication for tE2 by the FDA and Health Canada. I heard that E2-I experienced the problem that there is no financial incentive for either generic or brand name holders to participate in prodding the FDA or Health Canada.
I figure, there must be a way forward. I see some promising leads. The FDA has initiated a Drug Repurposing initiative. NCATS has started their Repurposing Generic Drugs program. Although these seem to be moving very slowly, many seem to believe progress will now be much faster than the former pace of imperceptible. There are organizations who claim they exist to help people or groups who want to repurpose drugs, i.e. Every Cure, REMEDi4ALL, and more I'm just starting to find out about. I want to hear from anyone with experience getting FDA or Health Canada approvals.
By the way, I've heard discussion that a low dose of tE2, something around the dose a woman would take for HRT, added to whatever LHRH agonist a patient is taking can help with the LHRH agonist side effects. They were calling it add-back tE2. Doing this seems to appeal to some patients who at present are reluctant about high dose tE2 for whatever reason. As for me, I want to experience life as a PCa survivor without Orgovyx at all. YMMV.
Thanks, David! I did some digging, and I don’t see a program at Health Canada comparable to the FDA’s Drug Repurposing Initiative. REMEDi4ALL is EU-based, so I'm not sure how helpful they would be for the US and Canada. I think your best place to start is the NIH-sponsored Repurposing Generic (ReGen) Drugs Evidence Package Challenge. The team leader submitting the application must be a US citizen (Dr. Schellhammer?), and SURF, E2-I's non-profit, could act as the legal applicant and receive the prize funds. E2-I would provide project leadership and evidence synthesis. But that only gives an organization money to pursue FDA approval. There would still be a lot of work after receiving one of the prizes. I’ll send you a separate message with details.
Based on the evidence available today, I think the strongest initial case for FDA approval would be transdermal estradiol as androgen deprivation therapy for men with locally advanced, nonmetastatic castration-sensitive prostate cancer, since that is the population supported by the recently published PATCH phase 3 data. In my opinion, pursuing a broader prostate-cancer indication before the metastatic PATCH results are available would have a much lower chance of success. Attempting to bundle additional indications into the same initial application would likely weaken the regulatory case by moving beyond the population with the strongest phase 3 evidence.
Another fascinating study and report, Keith. Thanks for sharing this info. A friend whose PCa has metastasized to his bones is currently on conventional ADT, and he reports that the hot flashes can be unbearable at times. I'll have to tell him about your experience.
For me, I glommed immediately onto your discussion of DES. I was a DES baby. After two miscarriages, my mom's doctor prescribed DES to allow me to develop fully to term. It worked (obviously) but I've always wondered how that therapy affected my own development. (There are studies of female DES babies, but none for males that I know of.) Gynecomastia was my biggest issue as a kid, and it's still something I deal with (although surgery 30 years ago helped). Mom even thought that the DES might have made me gay. I told her that was a benefit, not a drawback. (Smile) Today, I still feel like my hormones aren't typical for a man. My PCa was fully contained, and post-surgery my PSA remains undetectable. I am not on any type of ADT. But my testosterone level is always at the bottom of normal (last test 282) while my estradiol is at the top of normal for males (39.2). Perhaps that will benefit me in the long term!
Sending lots of positive thoughts and hopes to you that this treatment continues to benefit your long term health! Hugs.
Hi Steve. I'm so sorry to hear about your and your mom's experience with DES. I only touched on one controversy about DES because the article was so long. It is unfortunately a notorious drug for many other reasons, including increased cancer risks for mothers who took it and their daughters. Thanks so much for the well wishes. I truly appreciate that.
It's probably easy for me to blame DES for some of my health issues, and without any studies on males whose mothers got DES during pregnancy, I'll never know if there's a correlation. But it's also good to know more of the history, so thanks again.
Keith you remain a beacon of light and wisdom in the sometimes dark areas in medicine. I too pray that
your clinical response continues with decreasing PSA values and improvement in the quality of life you deserve. Blessings my friend. 🙏
Thank you John. As always, you are so eloquent and so kind my friend.
Fantastic, Dr. Holden, congrats and thank you for sharing all of those details!
Thanks Pete!
I'm following your journey here and I'm really happy for you!
If you have time for questions: can estradiol be used after Taxotere? Also can estradiol be used in the form of a 2mg tablet, instead of transdermally? Thank you
Hi Noa. I personally would never take oral estrogen at any dose due to the increased risk of blood clots and cardiovascular events. As far as tE2 after Taxotere, one of the studies I referenced showed men responding to tE2 after chemo -> https://pubmed.ncbi.nlm.nih.gov/22460098/ So run that small study by your oncologist.
Thanks so much for your reply Keith!
It's for my dad, and his oncologist is not too open to suggestions, but we'll try.
Just another question if you have time: both extandi and abiraterone stopped working. Can he take estradiol after both of these failed? Thank you!
I don't see why not. Some men with CRPC have had responses to tE2 after heavily treated with other drugs. I'm sorry your Dad and you're family are going through this. Maybe a second opinion with another oncologist. Just a thought.
Thank you so much Keith!
What an excellent post! I had 6 months of ADT last year and experienced frequent hot flashes, muscle loss, osteopenia, metabolic changes. If only I had known about the patches. My urologist is almost certainly not familiar with these findings. This is a good starting point for future discussion.
Hi Mike. So sorry you have been experiencing that. Best of luck with your urologist!
Hi Keith,
I'm very happy that this is working out for you. Take care,
Jeff
Thanks Jeff!