I would like to connect with fellow warriors that are HSPC and on Darolutamide to discuss Time to Failure, early detection assays etc...

[KocoPr]

Hello fellow warriors, Is there any other warriors that are still hormone sensitive and taking darolutamide?

Are there any HSPC taking it without docetaxel.

Trying to find data on length before drug failure?

I have been on it for 6 months now.

I have been interested in early detection strategies for resistance besides PSA which in my opinion is to late.

The failure mechanisms I have found so far are

1) Aldoketo Reductase 1C3 which is back door for DHT production.

2) Neuroendocrine which is a very bad cancer to get and is small cell cancer that is similar to small cell lung cancer and treated the same as SCLC.

3) There are no AR variants or androgen dependency that I have found thus I don't see a treatment that utilizes androgens as a further treatment such as anothe AR inhibitor nor Superphysiological Testosterone like in BAT protocol.

I recently found an early marker for neuroendocrine PCa and it is LDH (Lactate Dehydrogenase).

Advances in neuroendocrine prostate cancer research: From model construction to molecular network analyses

nature.com/articles/s41374-...

"In addition, before the diagnosis of t-NEPC, changes may be observed in the pathological and molecular characteristics of the patients. For example, in certain cases, the disease progresses rapidly when PSA levels are low, liver metastasis is detected shortly after the detection of elevated lactate dehydrogenase (LDH) levels, and “non-AR-driven” characteristics appear immediately after the loss of TP53 or RB140. These results indicate that the expression of these “predictive” factors should be tested earlier for the early diagnosis of NEPC."

Second generation androgen receptor antagonists and challenges in prostate cancer treatment

ncbi.nlm.nih.gov/pmc/articl...

" The utility of these agents has expanded with the emergence of second-generation AR antagonists, which began with the approval of enzalutamide in 2012 by the United States Food and Drug Administration (FDA). Together with apalutamide and darolutamide, which were approved in 2018 and 2019, respectively, these agents have improved the survival of patients with prostate cancer, with applications for both androgen-dependent and castration-resistant disease. While patients receiving these drugs receive a benefit in the form of prolonged survival, they are not cured and ultimately progress to lethal neuroendocrine prostate cancer (NEPC). Here we summarize the current state of AR antagonist development and highlight the emerging challenges of their clinical application and the potential resistance mechanisms, which might be addressed by combination therapies or the development of novel AR-targeted therapies."

[Heykm01]

Koco,

I am on ADT/darolutamide as part of arasec trial (no docetaxel). Started just after you - in august. I am a de novo metastatic case. Thank you for the articles, you've given me some homework to do . . . .

[KocoPr in reply to Heykm01]

i search trials all the time and i never saw this. It is perfect for me to follow up on the results.

Estimated Primary Completion Date  :June 22, 2024

Estimated  Study Completion Date  :June 22, 2026

Thank you for pointing this out to me!

[Heykm01 in reply to KocoPr]

also check out the aranote trial. Aranote is an international trial - double blind with placebo. Arasec is open label, US only.

[podsart]

may I ask what insurance you have and how did your dr get insurance to cover daralutamide for your case? I am trying myself. If u had been taking a statin what did u do about that with daralutamide?

[KocoPr in reply to podsart]

I had stopped taking atorvastatin way before I started Daro. I was taking Atorvastating for fighting PCa not heart/cholesterol issues.

I am on medicare with a supplemental ins. my hospital is MGH and got me a grant for both Daro and Orgovyx.

[podsart in reply to KocoPr]

thanks; so Dara covered by grant not Medicare .

[KocoPr in reply to podsart]

correct.

[Oldie68 in reply to KocoPr]

What is a "grant"? United Healthcare advantage plan charges $700/month for daro.

[KocoPr in reply to Oldie68]

some hospitals have large endowments like MGH in mass that are used for these purposes.

[KocoPr in reply to Oldie68]

ask your hospital’s oncologist and then if that fails you might try your hospitals patient assistance program

[KocoPr in reply to Oldie68]

Hi Oldie68 did you ever gt on Daro? Were you able to get assistance in the copay of $700/month?

[Oldie68 in reply to KocoPr]

I am still working and have health insurance through my employer. Not sure how to get assistance with the $700/month. Hopefully there are supplemental plans that help. How did you chose yours?

[KocoPr in reply to Oldie68]

I would listen to youtube channel “Medicare School”

I got my supplement plan 5 yrs ago so I can’t remember why I got that particular one. They change from year to year.

I got the HMO with Rx saver.

[KocoPr in reply to KocoPr]

Let me correct this statement. I found out via MGH pharmacy that they cover the copay i would have had to pay. My Tufts supplemental plan covers the rest.

[Blueslover in reply to KocoPr]

Is there a problem taking stations with Darolutamide? I take 2 of themHugh

[KocoPr in reply to Blueslover]

i use this site to check drug interactions

webmd.com/interaction-check...

[podsart]

thanks, good luck

[KocoPr in reply to podsart]

Thank You. I know some drug manufacturers have a patient assistance program.

Bayer

nubeqa-us.com/patient-assis...

[binati in reply to KocoPr]

In India I am using Darolutamide and there is a patient assist program. I get a 60% rebate on the medication at present.

[maggiedrum]

Thank you very much for your question and your references. I hve been told by my oncologist that SOC (FDA appoval) and my insurance only covers darolutimide in conjunction with ADT. The articles referenced are unclear as to this requirement all though one does mention it.

Reading the articles, and especially drilling down in the references, brought me to a very interesting study that covers QoL for metastatic disease whether CSPC or CRPC. One article in particular came to the conclusion that palliative care should be started very early for those with metastatic disease and NOT wait for the last 6 months of expected life. It also gave the time to death in tables that I have been searching for for a couple of years now. These are only statistical ranges for various years from diagnosis, etc. I have seen these values in one other study report but not as definitive as this report gives.

While it does say that QoL is not the same for any particular man, it does say that there are a couple of QoL problems commonly mentioned - pain and fatigue. Pain is primarily related to bone metastasis and fatigue in just the progression of the PC measured by the usual means (I assume by PSA levels and increases and by imaging).

[KocoPr in reply to maggiedrum]

The fatigue is from ADT, the pain could be from bone mets but warriors ond ADT with no bone mets like myself also have joint/muscle pain which is from ADT also.

I offet a lot of fatigue and pain by taking Ostarine 5mg/day for muscle and joint pain and cardarine for fatigue isdues.

[KocoPr]

interesting site and service. Looks like you have to qualify and I assume it is for financial hardship. Im wondering if you can go through your hospitals or insurance company patient advocate for this assistance.

[KocoPr]

exactly

[binati]

I think there is a patient assist program in India as the first place that a generic drug will surface is India. They have tied up with a company that makes generic Enzalutamide. Looks like most CRNM PCa patients in India might be getting assistance.

[MateoBeach]

I am mHSPC and on modified BAT. Did a personal test of darolutamide added to Orgovyx for my 4 week ADT phase this month. Only side effect was high BP.

Ride it until it fails without concern. You can use a few cycles of BAT then to likely restore response to it. Or you could insider a modified BAT program as I and others here are doing to hopefully avoid becoming CR as soon and cancel out body harms from continuous ADT (not SOC). Paul

[KocoPr in reply to MateoBeach]

Thanks Paul,

I am leaning to staying on Daro/Orgo and researching for early detection assays like LDH, ASP, (any others?)

Question on scans. shouldn't I get once a year FDG-PET scan now once/year in case I develop AR independent resistance?

[KocoPr]

hmmm ignore my last two posts as it looks like they were in response to a post or two that were deleted.

[KocoPr]

i have started a modified BAT protocol with T-propianate in order to delay castrate resistance and for QOL.

Keep the beast fed and loving androgens but keeping it caged with darolutamide. It’s been 4 cycles so far and doing fine.