This drug is for patients with Castration Resistance Prostate Cancer , apparently the clinical trial (NCT02200614) was completed on September 3, 2018, and was successful. Increases the life expectancy from 18.4 to 40.4. Unfortunately we have to wait another 18 months for the result to be published, and possibly a lot longer for the marketing.
onclive.com/web-exclusives/...
Bob
It was for Darolutamide for non-metastatic CRPC. It has already been published, and I expect the FDA will approve it within months, along with the already approved Erleada and Xtandi for this rare indication.
nejm.org/doi/full/10.1056/N...
Saw my MO last week and she said that if the cancer comes back after the pelvic radiation and Lupron this drug will be my likely next step. She said in this case I would be labeled Non-Metastatic Castration-Resistant. I assume that if this too fails then I would move Zytiga or Docetaxel depending on number/location of mets.
Does this sound correct?
Jim
Allen
The time line I stated was in the Clinical trial, where did you get the within months ?
Bob
It's already been published, and the FDA has already approved 2 other drugs on fast track for the same indication.
Tall_Allen, I have become an avid follower of your postings; wish my oncologist was more personable in his approach (not complaining--only just a little). What does it mean to have non-metastatic CRPC? When I started Lupron/Zytiga therapy I was told that my bone scan showed a spot on my lung and one in my pelvic region. A very uncomfortable lung biopsy proved negative for cancer. Only the one spot remained in the pelvis. So far, my PSA has been undetectable. In August of this year I will be two years on the combined therapy. Please direct me to sources that explain what follows when one no longer responds to ADT. Is that the beginning of the end?
Non-metastatic currently means not detectably metastatic on a bone scan/CT. so it wouldn't apply to you. There are lots of available therapies after zytiga fails - docetaxel, Xtandi, Xofigo, Provenge, and Jevtana so far - more to come.
Allen
I know what Non-metastatic means. I also have taken all the drugs you mentioned and few more.
I just asked you where did you got your few months ? Were you trying to change the conversation by saying something else ?
Bob
That was in reply to another poster. This site is a little confusing - you have to look at whom it says each post is "in reply to."
Janssen submitted the new drug application to the FDA for apalutamide before publication on Oct 11, 2017. FDA approved it on Feb.14, 2018. So, 4 months.
Bayer just last week submitted its new drug application for darolutamide.
another utalmide to add to the cast.....i only wish we could find a mamab immunizing confederate to meet the crpc needs. thats where the holy war is being fought.
I have a question...i'm essentially in remission now..my PSA has hit near nadir at .06...i'm determined to stop my medications asap to see how my body compensates given the oddball extras i've introduced to the mix...ie turmeric and the shadow of dukoral vaccine....assist in my recovery. if i do relapse, by my reasoning, it is that i'll likely flare as an androgen sensitive daughter....the contra is too horrendous to consider...but ultimately the ultimate object of the exercise... I would not be averse of course to go the BAT route but i'm not sure i'd find a sympathetic caregiver to that idea. I just can't bear to wait years to fail my ADT's....i'd rather face it now while I'm as young and fit as ever.
Oh. My husband and I have felt the same. But the time gained in the interludes before the cancer has morphed into a new form and between new interventions may be the only time you have. So really you don’t want to rush through them but totally try to distract yourself and live as best you can. We all have expiration dates. That’s my 2 cents.
Hi. Wishing you well. And the doctors who give expiration dates are sometimes wrong. If I make it another 6 months, don't get hit by a truck or something, I'm going to do an Albert Einstein and stick my tongue out at my doctor.
Well....there is an indication that in giving up ADT treatment, you can prolong the inevitable so to speak....thereby yet buying even more time.
To me its a gamble either way....that one maintains the constant ADT regimes in hopes it lasts for the mean or better, or, gamble you may not develop a nasty variant and outlive the standard practitioners with the option of restarting ADT when a regular garden varieties resumes its less deadly march....and moreover develop immunity or whatever in the (unlikely) hope that you've won the war with the first volley.
Whats alluring to me is that its not risked in many cases although some here have suggested good results when they've boldly tried.
We urgently need a drug for nmCRPC that does not target the androgen receptor
why?
The current drugs all target the AR. I have started to fail on Erleada and my MO thinks my cancer is morphing into neuroendocrine cancer. I am 23 years into this fight and still do not have any detectable mets. So the need for some drugs that are effective against t-NCPC. I thank you TA for all your responses to other members.
Have you had blood tests for chromogranin A, synaptophysin, and neuron-specific enolase? Often there are lytic bone mets instead of the sclerotic bone mets that men with PC usually get (they do not show up on a bone scan). There is a new kind of PET scan, Ga-68-DOTATATE, that may be able to find them. If that's what you have, there are some innovative therapies:
pcnrv.blogspot.com/2016/12/...
I suggested the CGA test but MO shot it down as too unreliable. I copied a segment from a paper that states that if both the CGA and NSE tests are above a predetermined value, the confidence level is 95% that you have NEPC. I see MO again in May and bring this to his attention. NOTE PSA levels while on Eligard and Erleada:
08/03/18 0.6
09/23/18 0.7
11/01/18 0.9
01/06/19 1.3
02/27/19 2.4
Many thanks TA. Your knowledge of PCa is indispensable.
Mike P
I have found that emailing links to articles in peer reviewed journals in advance of a face-to-face meeting may sometimes be helpful. That gives him time to consider it without being put on the spot. I agree that CGA alone should not be used as the basis for changing therapy.
TA:
You, i and everyone else knows how obscenely unfair this drug trial target results are.. The particular drug trial we are talking about here has been completed for non-metastatic castrate resistant patients but not metastatic ones. why is that ? In addition, this drug works similarly as xtanti, but with much fewer neurological side effects..So why in God's hell would they not conduct trials as well on metastatic guys for the same drug. We all know it is a better drug than what is currently available.
You know what I think? It is for economic gain reasons...Most guys with PC (95%) have non-metastatic type. Only a few of us schleps have the metastatic kind so not enough money with such a small %...Also, this new drug will be in direct conflict with Xtanti and Zytiga so since I am sure the criminal Pharmies have a shitload of back supplies of their grotesquely overpriced drug Xtanti and Zytiga, why would they allow a better drug with fewer side effects hit the market when us Metastatic guys are still forced to take the older ones.
Think about it...The system is BS and some CEO's and doctors need to be investigated...A shame that the medical field is now only focused on profit vs. saving lives
Tall why can't metastatic take the drug
because they haven't yet proved it does anything for men who are already detectably metastatic.
i don't agree. This trial was completed first for the simple reason that with non-metastatic CRPC they only had to show that it slowed down the occurrence of first metastases. In men who are already metastatic, they have to prove that it extends survival - that takes much more time. They certainly are conducting those trials.
A web search turned up this trial: clinicaltrials.gov/ct2/show..., looks like we should have results in August 2022.
Every time I see one of these I get that surge of hope ,then I read that it’s for non Mets cancer. What a let down. 😢😢
Tall is zitega the last resort
There are lots of medicines- more to come.
It doesn't make sense when you think about it. Why not administer it to the met guys going on current last resort drugs with nothing to lose.
In the US, there is a "right to try" law, but the manufacturer has to agree.
Tall A. There is no question that this drug works on Met guys just as well. I doubt that it extends life more than zytiga or xtanti. Probably the same effect. The big difference is that it has fewer side effects than xtanti and, if I'm not mistaken, does not require taking prednisone as is the case with zytiga.
Poofer
My understanding is, as long as it has not metastasized, it will stop the growth of PSA , delays the time to become metastatic. After the PC become metastatic , certain genes have already mutated , example the p53 Gene is a Tumor Suppressor ,the drug will not stop the growth of the tumor, it becomes ineffective. PC have gone to a higher shift.
I believe this is one of the factor it may not for mCRPC
Bob
There may be "no question" in your mind, but proof is lacking.
From what I have been reading, this drug acts in the same way as Xtanti, but with much fewer neurological side effects. Xtanti is widely used for metastatic PC as we all know. Why not fast track a similar drug with fewer side effects for metastatic guys?
It will be fast-tracked as soon as they obtain actual proof that it extends survival in metastatic men. There are many "similar" drugs that have failed to demonstrate clinical efficacy.
Thanks TA
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