Unless I missed it, I haven't seen a post about the anticipated-this-fall results of the PATCH Study. I just noticed that it was reported out at the ESMO meeting a couple of weeks ago. They noted "key takeaways" to include:
**Transdermal estradiol is as effective as LHRH agonist and there is no detriment in terms of prostate cancer outcomes or overall survival in starting androgen suppression with transdermal estradiol
**Transdermal estradiol provides choice about expected side effects and route of administration allowing for personalized treatment plans.
** Transdermal estradiol should be a standard-of-care ADT option in M0 disease.
Thanks for the reference. I tried using the search tool here but that one didn't come up, and I did for some reason miss it. My one question concerns metastatic PC. I can't glean in the technical points of the report why they concluded that patches should be SOC for non-metastatic, but have not said the same for metastatic. BTW, after reading the study, my MO concluded that it would be equally appropriate for metastatic [my situation]. Maybe somebody here can explain that?
As far as I know the trial did not include metastatic patients. Therefore the trial cannot recommend patches for metastatic patients. On the other hand, if you are metastatic, Lupron or patches alone is not enough. You have to add Abiraterone, Enzalutamide or Apalutamide as the guidelines recommend for you.
The patches lower testosterone like Lupron, with lower side effects e.g. almost no bone loss. They are not more effective against cancer than Lupron. If you have bone mets your doctor should not use Lupron only, but combine it with one of the new, stronger drugs. Same with the patches. If you have affected lymph nodes in the pelvis detected with a PSMA PET/CT you could choose Lupron or the patches without adding additional drugs.
Great post LQ! I do believe this is a big deal. We know people who have been on high-dose estradiol successfully for a very long time. But it's not common yet; at least now the PATCH study validates.
It's important to distinguish two uses of transdermal estradiol patches.
I think the use you are referring to here from the PATCH trial is high-dose estradiol as a complete substitute for the regular ADT options as we know them (e.g. Lupron/Eligard or Firmagon/Degarelix or the new oral Orgovyx/Relugolix). (I'm not completely sure if one followed a PATCH trial therapy regime, if that means you're only taking high-dose Estradiol, and not anything else such as an ARPI or a AR antagonist at the same time.)
I'm interested in the second potential use of estradiol. This is in the possibility of low-dose transdermal estradiol as add-back for the loss of estrogen resulting from metastatic prostate cancer hormone therapies.
ADT and other therapies for metastatic prostate cancer deliver zero testosterone. This is a success! (At least until progression or resistance.) Zero testosterone however also means low or zero estrogen as an unwanted but unavoidable - until now - side effect. The reason is that our bodies only make estrogen from testosterone. So, no testosterone, no estrogen.
Low or zero estrogen is responsible for osteoporosis, cardiovascular risks, and possibly other things such as fatigue that we are afflicted with when being treated for metastatic prostate cancer. And we are tempted to blame our meds directly for these side effects - instead of understanding that these side effects are in fact only indirect effect of these therapies. We didn't want to suppress estrogen! We just did. And oddly a lot of doctors in my experience don't really talk how about the significance of this. Except to offer bone strengthening drugs.
Low-dose transdermal estradiol as estrogen add-back, in circumstances of testosterone suppression, is not intended as a substitute. It would be used along with whatever one is using now anyway.
I'm still looking into this; I know people who do transdermal low-dose estradiol add-back. But I'm cautious. My motivation though is because of the side effects. Maybe we don't have to suffer the consequences of estrogen suppression. If one could safely do low-dose estradiol for estrogen add-back, then this could be a big help for quality of life.
I'd like to know if the PATCH trial addresses low-dose estradiol as well.
I totally understand your response, and appreciate the observations you've made. I'm curious: How come you are interested in the "low-dose route" instead of going the "high dose route"? I've been thinking that if I'm bothering with the patches, why not go all the way and use them instead of Lupron?
Why should I not switch to full-on high-dose transdermal estradiol metastatic PCa therapy, as defined by the newly presented PATCH RCT trial?
Because I'm on triplet therapy now and it's working well for over 2 years - although I guess you could say that for all intents and purposes, because the Docetaxel chemo is done over a year and a half ago, it's just doublet therapy. But why mess with a good thing? Why contemplate a complete strategic change to my therapy if my therapy's working?
On the other hand, low-dose transdermal estradiol is just an incremental change to address side effects of my existing doublet therapy. Adding a low-dose scenario there would be no change to my current doublet therapy regime. Low-dose estradiol would just an add-on. And I'd continue to benefit from my existing regime.
Eventually we are all expecting one's doublet therapy to exhaust itself. Hello progression. Hello hormone resistance. In such a case maybe switching to a PATCH regime would be attractive. I wonder if this is possible. Can one switch? Would resistance carry over and undermine a new PATCH regime? Or would it be a fresh start? And what about nasty things like AR negative, neuroendocrine and small cell metastasis follow-along cancers?
Thanks for the additional explanation. Makes sense! I wish I could say that my therapy is working as well as yours but alas, such is not the case. (see my updated bio if you wanna know). But since hot flashes are a serious problem for me, I am welcoming this reportl
The early PATCH phase-I trials used 1-2 patches (0.1 mg/24hr), and was reported by R. Langley et al in 2008 and N. Russell et al in 2017. Those results were positive, and would be considered "low-dose" E2 therapy.
I imagine that many MOs have been resistant to accept this -- I know that mine has. But she is reviewing all the ESCO studies right now, and she told me she is now convinced that it would be an OK choice for me. I think that the "hard science" types really want to see the evidence in what they consider to be a 'quality' study. Now she's got the evidence!
I used transdermal estradiol gel for about a year. I stopped using it quite some time ago when my PSAs dropped to the undetectable level. I assumed that my prostate cancer is sleeping?
Wow! fantastic. I'm PCa, undetectable for 9+ years but on Zytiga ,500 mg now every day. I think I shall "follow you". on this forum, not stalking though!!!
Yes, the positive PATCH results is a big deal, in my opinion. But, since it's not a current Standard of Care, it has to be used Off-Label. It will take time to be accepted by Urologists and MO's, perhaps a year or two.
I currently use estradiol gel, made by my local compounding pharmacy. It costs about $60 per 2 months, out of pocket. I'm also taking Orgovyx ADT, just to hit the PCa as hard as I can. I have no hot flashes, and I'm expecting to be increasing bone density. I also did SBRT radiation therapy. My PSA is down to 0.08, so I am pleased about that.
You should get a DEXA bone density scan to establish a baseline bone mineral density.
I do have some small breast enlargement and tenderness/nipple sensitivity. But, that the only side effect that I've noticed. My wife doesn't care how I look.
I have no hot flashes. Estradiol therapy also reduces blood glucose, increases good HDL cholesterol, lowers blood pressure, decreases bad LDL lipids, and lowers fatigue, compared to Lupron (etc.) ADT. Estradiol also used to treat traumatic brain injury in the ER, because of its effect on reducing swelling and helping blood vessels.
My PCP prescribes my estradiol, since it is Off-Label.
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Transdermal Estrogen and Bone Mineral Density
