Advanced Prostate Cancer
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my husband is being treated by the VA due to his Agent Orange status.

does anyone know what this Senate ruling that is supposed to allow us to request drugs still in trial as a last ditch attempt at survival means for us?

my husband has flunked casodex, zytiga, and enzolutamide, docetaxel and another platinum based chemo.

we have an appointment to qualify for xofigo on tuesday...but, i think he might benefit from darolutamide. each time he flunked the previous drugs he responded dramatically to the next drug in the pipeline.

does anyone know how to go about getting a drug that's still in trial???

12 years into aggressive gleason 10...with only bone mets.

14 Replies

I'm going to see my VA oncologist next week. She is also an oncologist at the University of Michigan cancer center. I will ask her the question that you have presented to the group. I'm also an agent orange victim. I will message you if she can muster some sort of response.

Another possible lead, if you use the myhealthevet feature, you can message the pharmacy and ask a pharmacist about the possible availability of the drug.

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Could you post whatever you find out? I am also being treated at VA and would be interested in the answer. My next appointment isn't until September. Thanks.


gregg57 I certainly will post everything , if anything I find out. I fact i will message you just to make sure you don't miss my post.



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Well, what I do know is, that unless Darolutamide is suddenly ''fast tracked'' it's not going to be available until late 2018, if then. what I do NOT know is if that Senate ruling still needs to go to the House of Representatives for a vote. Another thing I do NOT know is, since the VA only pays for FDA APPROVED medicines, if they will consider paying for Darolutamide if it is not officially approved, yet.


"each time he flunked the previous drugs he responded dramatically to the next drug in the pipeline."

1. That is probably not the best decision making criteria. That is sort of why the FDA is so careful about drug approvals... to prevent the unscrupulous from taking advantage. See generally

2. I think the law you are talking about is a federal Right to Try Law. I don't believe that has passed, but many states have something like it. see:

But these laws have two drawbacks (a) the pharmaceutical manufacturers do not have to participate, and there are few good reasons for them to do so, and (b) the patient has to pay for the drugs out of their own pockets. Oh, and they are limited to terminally ill patients (beats me what exactly terminally ill means under these laws and how imminent death needs to be... perhaps all you need is a letter from your doctor)

3. Managing androgen levels is a pretty nuanced art. If you are second guessing your Doc, probably the cheaper and most effective solution is to find some well-regarded prostate cancer specialists and get a few second opinions. If you don't have the time or patience to sort around finding them, try some major medical institutions like the Mayo Clinic and the Cleveland Clinic.

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we have several good doctors. we just need darolutamide before he dies waiting for it. we're willing to pay for it. we've been to DANA-FARBER and Johns-Hopkins, in the past, and our VA doctor practices at UPMC, himself. the standard of care doesn't vary that dramatically.

when his biopsy came back a gleason 10...the urologist actually asked them to redo it. the note the urologist got from his buddy at Bethesda said, ''if there were a gleason 12 or 14, this guy would be it.'' that aggressive. the drugs don't come down the pipeline fast enough for him...and with two other cancers, he's not a candidate for clinical trials.

we just need the next best drug or a miracle...or he's cooked. xofigo begins this week.

thanks for your reply


Have you considered contacting the drug maker Bayer? They might know of some way for you to get it.


You may very well have already seen this, but a review might lead to more informational leads?

On another subject, your husband did not "flunk" anything. None of the biological responses or nonresponses of his prostate cancer to drugs or treatments are under his personal voluntary control.



Flunked? You sound like it's your husband'S fault - lighten up


Although I don't have anything to offer for the information you have sought, thanks are due to you for sharing with us a 12 years successful battle with a GS 10 PCa. The responses of our group which I read with my usual interest also give the opportunity to learn about new drugs and the practical difficulties one has to encounter before they come from the bench to the bedside due to bureaucratic upheaval.

Hope your problem will be resolved soon and all the desired benefits will accrue for the well being of your husband.



There was a recent article in the Journal

Expert Opinion on Pharmacotherapy 

Volume 18, 2017 - Issue 9

on "Darolutamide (ODM-201) for the treatment of prostate cancer"

It goes into considerable detail about the percentages of responses, the duration of responses, etc., of Darolutamide (ODM-201) in the Phase I / II clinical trials. This information might be helpful in your decision-making and the formation of your expectations in regards to this drug, should it become available to you. It also describes the global Phase III trials whose results are still quite a ways out (and for which your husband may not meet the eligibility criteria due to his prior treatments/conditions).

In the meantime, you might ask your doctors what other options might be available. Perhaps double check about Jevtana, Provenge, or getting genetic testing for inherited germline mutations that might be treatable, or genetic testing of tumor samples for targetable mutations, etc.



thanks for taking the time. Provenge is out...would take too long. he can't have another drop of chemo due to his neutrophil/red/white blood cell issues, and because his neck cancer is boring a hole into his carotid artery and is effectively being ''controlled'' by keytruda at this moment. Jetvana would compromise that, and he's already flunked radaion and three chemos and combinations thereof for the neck cancer. both cancers are in a race to kill him...which is why, since he responded so quickly and so well for years to casodex, zytiga, and xtandi, any time he can ''get'' from another hormonal therapy that may target other factors, will probably keep the Pca from winning that war. he has had genetic testing ...negative results.

you must understand that he's a separate class of cancer patient. his issues are all due to extensive exposure to agent orange...very extensive and intimate exposure. he also suffers from a stage 3 skin cancer. all three cancers have netted him a total of 118 IMRTs. his system can't take anymore. they don't even want to spot radiate his most painful mets, anymore.

to those who took issue with my using the word ''flunked'' i can only say, that after 12 years of using the vernacular, it gets tedious. i have spent MY life with urologists and oncologists and absolutely every one of them understands ''flunked'' and after i use that term, they feel quite comfortable using it, themselves. just saves a lot of time, and, in this case, typing. perhaps you can think of it as ''the drugs flunked his cancer''. he's my hero. i do not consider him a flunky or any kind. each day, despite his unbearable pain he manages to make me laugh every time he opens his mouth. we spit AT cancer in this house, we lend it no credence. to give you an example, the last time his carotid artery exploded and he lost 4 pints of blood before EMS could get here, the doctors suggested we just quit treating him and allow him to pass. i looked at that doctor and said, ''as far as i am concerned, he's just a regular guy who happens to have a tumor.'' i STILL remember the look of his frustration with me. THAT was THREE YEARS AGO...and that's just the neck cancer. his prognosis at diagnosis for the prostate cancer was a 1% chance of surviving 3 years with treatment. THAT was 12 years ago. Stage 3 basal cell skin cancer is a ''walk in the park'' and kid stuff in comparison.

so, my quest now is a non-negotiable search for darolutamide from the manufacturer, be it as a compassionate use designate, or under this new ''right to try'' assignment and a hope that tomorrow's visit nets him some time and pain relief from xofigo while i continue my quest.

if anyone stumbles onto the avenue to that drug. please let me know.

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P.S. this game we are all's called playing for time...that time for the NEXT BEST treatment to surface.


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