FDA Approves Darolutamide Plus Docetaxel for Metastatic Hormone-Sensitive Prostate Cancer

[tango65]

Other triple therapy approved by the FDA. The article has the basic results of the ARASENS trial.

onclive.com/view/fda-and-em...

More info:

urotoday.com/conference-hig...

[CAMPSOUPS]

This is great news for those it pertains to. Thanks for posting.

[tango65 in reply to CAMPSOUPS]

It only applies to newly diagnostic metastatic castration sensitive PC.

[CAMPSOUPS in reply to tango65]

Right exactly. I'm not happy for anyone following in my footsteps but if it be so I am happy they will have these triplet therapies available.

[Cooolone in reply to CAMPSOUPS]

Agreed!

[dhccpa in reply to tango65]

You can't add it to Lupron (sole treatment) several years in? It has to be prescribed on front end? Thanks.

[rsgdmd in reply to dhccpa]

I believe the idea is to have It concurrent, so have 2 layers of ADT while going thru chemo & then beyond. That was the plan for me, but abiraterone caused my bilirubin to shoot up. So I'm on Lupron during chemo & will try abiraterone again after. Though will ask about darolutamide after this article.

[dhccpa in reply to rsgdmd]

Yes, the trials seem to start up on diagnosis of metastatic condition. I've never been clear if one can add Zytiga, Xtandi, etc. on top of Lupron at any time while Lupron is still working, including several years in. Some docs get hung up on the exactness of the trials.

[MamawV in reply to dhccpa]

Hubby’s MO said they use to start the Zytiga/Prednisone or Xtandi once Lupron/Eligard stopped working but now they suggest it at the beginning along with the shots.

[dhccpa in reply to MamawV]

Yes. However, in the situation where a patient was started on Lupron four years ago and has been stable with PSA of 0.6 for that 4-year period, should Zytiga now be added? I haven't seen a consensus on that.

[Seasid in reply to dhccpa]

After 6 years on Zytiga plus corticosteroids your liver and your body probably would have enough.

Therefore, if you are doing fine now i would like to add either Nubequa or maybe Xtandi if I would have brain cancer.

Did you have a PSMA PET scan?

Before 2015 the order was like this: ADT, bicalutamide, Jevtana and after Jevtana failure finally Abiraterone.

If you start with ADT, Nubequa and Docetaxel that you have according to the clinical trial 63% chance that you are alive after 4 years.

If you start (like me) with ADT and Docetaxel than you have 50 % chance to be alive 4 years after starting ADT.

Nobody from the participants of the ADT, Nubequa and Docetaxel trial group development castrate resistance after 4 years (if they are still alive).

Therefore I believe Nubequa is a good choice to maximize your chance to stay alive.

We don't really know at this point of time which combination of therapies would yield with the longest survive time. I believe it is up to your cancer, how it will mutate etc. That is why we need to find a good medical oncologist to treat us.

I believe with ADT alone we have only 7% chance to be still alive after 10 years.

I wouldn't rush with Olaparib early untill Enzalutamide woks.

During the deployment of Enzalutamide new actionable mutations will develop.

[dhccpa in reply to Seasid]

Thanks for your input. I'm aware of those advantages for newly diagnosed patients. I'm four years in now with low PSA, stable scans, etc. The question is whether doublet and triplet therapy would add benefit at this stage. I'm 50/50 on the issue.

Interestingly, one year into this (2019), the PCa specialist at Moffitt said I was doing fine with Lupron only. Two months later, a PCa specialist at Mayo JAX suggested adding either Zytiga or docetaxel. So there was division even at the top Florida centers.

Regarding PSMA PET, they are not yet available in this area. However, in interpreting TA's comments, my understanding is that it would not change my treatment at this stage. After all, I haven't even had chemo yet. I have had annual Axumin scans for three years, along with MRIs of the prostate/pelvic region.

I didn't understand your comment about brain cancer. Could you elaborate on that?

Thanks.

[Seasid in reply to dhccpa]

I have a met in my neck just under my skull. Enzalutamide passes the blood brain barrier therefore i would prefer Xtandi instead of Abiraterone for example. I already agreed that i will be happy to try Enzalutamide after ADT fails. I don't have a brain tumor yet, but that is a worry of course.

Professor Epstein said that some people live long on ADT alone. I believe we have a better quality of life on ADT alone. I am not in a hurry to add anything. If the PSA doubling time is slow and the scans and symptoms are ok than i am not going to add anything. That's why we need good oncologists to advise us.

[dhccpa in reply to Seasid]

Got it, thanks. Best of luck heading forward.

[Spyder54 in reply to dhccpa]

DHCCPA, I’m in Tampa St Pete. PSMA PET is avail at Moffitt, Tampa Gen, Gateway Radiology. If u r on Medicare, they will pay for 1x p/yr. I was Dx on Oct 2020. 1 yr early for the ASCO announcement of ADT/3, and have been Lupron, Zytiga-pred only for 23 mos now. Was told inoperable/incurable. Had SABR/SBRT this Jan to Prostate only. We keep hearing early is better from all these studies, but you and I were too early. I have to wait until failure, then add Docetaxel, and maybe Darolutimide knowing it would hv been better early. Mike

[dhccpa in reply to Spyder54]

Thanks. I'm watching carefully but it wouldn't change my treatment at the moment.

[Shorehousejam in reply to Seasid]

My husband was just Dx 07/01 and started 07/06 Firmagon 

Zytiga w/ Prednisone 07/20

He had two chemotherapy sessions

 Can Nubeqa be added now ?

We are upset MO never mentioned or added this

[Seasid in reply to Shorehousejam]

Which chemotherapy are you doing now?

[Shorehousejam in reply to Seasid]

docetaxel

[Seasid in reply to Shorehousejam]

i received 6 cycles of Docetaxel chemotherapy 2 months after the start of my Firmagon injections. How many cycles of Docetaxel chemotherapy treatment will you receive? What is your PSA?

[Seasid in reply to Shorehousejam]

Would your insurance approve Nubequa? I personally would be happy with Nubequa.

[Shorehousejam in reply to Seasid]

yes I think so

[Seasid in reply to Shorehousejam]

where are you getting your treatments?

[Shorehousejam in reply to Seasid]

I just pasted my husband’s bio for you

Advance Metastatic Prostate Cancer with Ductal subtype

All four cores out of 15 with another core with necrosis and questionable atypical cells

Stage 4 Gleason 8

Pet Scan, CT Scan, Bone Scan, MRI, Transperineal Biopsy

Started Firmagon 7/6/2022

with Prednisone and Zytiga 7/20/2022

and Chemotherapy on 08/11/2022

Ductal Prostate Cancer is

aggressive and can’t be monitored by psa score.

As it can still spread by low non existing psa numbers.

Gleason 8

PSA 942.40 7/6/2022

To 2.87 08/03/2022

To 1.07 08/11/2022

To 0.41 09/01/2022

To 0.34 09/13/2022

The good news is no lesions on ribs, lung, liver, heart or brain, from scans dated between 6/28/2022 to 07/15/2022

We pray it’s still true

According to second opinion from MSK Dr Rathkopf

“Some uptake in something in chest area”

Will discuss with Medical Oncologist on 10/4/2022

Have to wait for new scans until Medical Oncologist is willing to do one.

To add to this horrible diagnosis my BRCA test came back with a mutation for BLM

***BLM gene***

Everyone has two copies of the BLM gene, which we randomly inherit from each of our parents.

Mutations in one copy of the BLM gene can increase the chance for you to develop certain types of cancer in your lifetime.

And here we are with a certain rare type of prostate cancer…

Ductal Adenocarcinoma an unusual or rare type of prostate cancer often missed altogether

or sadly under diagnosed…and clinically under staged.

Lesions that spread to ribs, liver, lung, heart and brain, plus other areas.

I am afraid of a clinician treated it the same as

Advanced Metastatic Prostate Cancer

[Seasid in reply to Shorehousejam]

here is a Google search for Nubeqa and GABA:

It looks like that Nubequa can cause less seizure than Enzalutamide or apalutamide.

google.com/search?q=Nubeqa+...

[Shorehousejam in reply to Seasid]

psoriasis is a skin issue like dermatitis, rash like, no seizures if that’s what you were referring to

[Seasid in reply to Shorehousejam]

i am just saying that Enzalutamide can cause falls.

I don't know about psoriasis and Firmagon or Nubeqa. I just know that apalutamide can cause redness of the skin. I am not a doctor nor an oncologist nor a dermatologist.

I had psoriasis but the dermatologist had a theory that it was related to a streptococcus infection. My PCP said that it is a good idea. I hat penicillin antibiotics and I didn't have psoriasis for 30 years now. Maybe my psoriasis was really related to streptococcal infection? I don't know, but I also had psoriasis 30 years ago and I don't have it anymore. I am on Firmagon and I never tried lupron.

[Shorehousejam in reply to Seasid]

thank you for sharing that I appreciate it

[Shorehousejam in reply to Seasid]

Question for you…My husband has severe psoriasis, studies show lupron has caused sever psoriasis flares, enough for hospital stays, is hard on the bones as he has lytic lesions not blastic, so he needs to stay on Firmagon and Zytiga with Prednisone

Lupron replaces Zytiga or Firmagon?

Is Lupron as good?

[Seasid in reply to Shorehousejam]

Firmagon can replace lupron. I am on Firmagon monthly injections. It is less convenient than Lupron but has advantages.

[Seasid in reply to Shorehousejam]

i can recommend to read this post about brain mets, but I hope that neither of us will need this information in the future.

For brain mets cabasitaxel chemotherapy is better as it is passing the blood brain barrier.

healthunlocked.com/advanced...

Nubequa should have the least side effects. It has something to do with GABA receptors? I am not a doctor but something like that was mentioned on this forum. You could google Nubequa and GABA

[Shorehousejam in reply to Seasid]

thank you, I personally think Firmagon is better than lupron, if you Google lupron, it gets pretty ugly lol

[Seasid in reply to Shorehousejam]

i didn't want Lupron as it brings more memory problems than Firmagon.

In fact that was my most important reason for staying with Firmagon.

Less chance of getting dementia. But again, i am not a doctor and you should do your own research.

Professor Richard Epstein (my first oncologist) did not recommend to me to continue with Firmagon as they have less experience with long time use side effects.

I continued with firmagon as I didn't believe that I will live for very long and I didn't like the possible memory effects of lupron.

With Firmagon injections you will get 50 % less chance to develop urinary tract infection. Etc

[Shorehousejam in reply to Seasid]

your experience is amazing, thank you again

[Seasid in reply to Shorehousejam]

well, it looks that you are in better hands than me. Try to get some advice from a dermatologist. It is very difficult to recommend further about psoriasis. For how long do you have that problem with psoriasis? I had it on my knees and elbows. It was long time ago. Thanks God I didn't have to become an expert on psoriasis but it was very anoing lol

I was using 30 years ago coal tar products for bathing. I am not sure if coal tar products are recommended anymore? Maybe they can cause cancer? I am sure that even your pcp should know more than me about the current therapy of psoriasis.

[Shorehousejam in reply to Seasid]

so, true had it for over 25 years, 15 years ago it started getting out of control, was on Tremfya but last injection was 3/2022 , can’t take immune suppressants with adt, defeats the purpose

[Seasid in reply to Shorehousejam]

i really don't know for ADT. Can you ask an immunologyst? Or even better if they call each other. Dermatologist, immunologyst and MO could discuss it with each other over the phone.

It is only my idea. I don't really know but I can understand your situation.

[Shorehousejam in reply to Seasid]

we have done that twice so far, like pc it’s a circle

[Seasid in reply to Shorehousejam]

i read a little bit about your Tremfya and it looks like that you should not use Abiraterone as it goes with 5 mg of Prednisone per day and that type of medication like dexamethasone also act as an immunosuppressant.

I have to say that my PCP prescribed me a cream or gell with some chorthycosteroids but said that it is actually not good for me but that he personly is also using that gel.

I believe that Nubequa could be a better choice instead of Abiraterone.

Can you talk to a hospital pharmacist about interactions between Tremfya, Firmagon and Nubeqa?

When I was on 6 cycle of docytaxel chemotherapy I only took dexamethasone around the chemo but I refused to take everyday a prescribed Prednisone as I so a Finnish study and they didn't use Prednisone everyday with the chemo. You should still use the dexamethasone around the infusions. (It looks like that the Finnish don't like the use of chorticosteroids. Finnland has a good oncologists. Maybe you could contact our member Brysonal about recommendation in Finland.

[Seasid in reply to Seasid]

he has a Finnish and also a London oncologist but finds that his British doctors stick to a pruven things like Abiraterone. He is (looks like that way) the first patient of his London oncologist who is using apalutamide. Finnland recommended either Enzalutamide or apalutamide. Finland didn't like Abiraterone as it comes with the use of Prednisone.

[Shorehousejam in reply to Seasid]

I haven’t had an injection of Tremfya since March and I don’t plan on it, I’m on topicals only right now

I didn’t realize you were in Finland…

I have appointment with a dermatologist this week and will keep you posted

[Seasid in reply to Shorehousejam]

i am in Sydney but our member Brysonal is in London and has a London and Finland oncologist. The London oncologist is very standard of care only prescribes Abiraterone. Brysonal had his 3x Lutetium PSMA treatment and after that 3x cycles of Docetaxel chemotherapy " bombs " in Finland.

If you want you can ask him for recommendation in Finland.

Finland has one of the best oncologists.

[Seasid in reply to Shorehousejam]

could you also please give me the link of your new (planned) Post?

[Seasid in reply to Shorehousejam]

more information about Firmagon injections:

"hansjd

4 hours ago

My husband has been on Firmagon for most of the time since diagnosis in Feb 2018. Was switched to an agonist (not Zoladex) for about 9 months but we switched him back to Firmagon despite the monthly injections . Reason: it's an antagonist which means 1) it also lowers FSH and is therefore more effective long term than an agonist 2) it has fewer CV complications than an agonist.

To counteract injection site discomfort, it is really important to not only inject slowly but to extract the needle slowly as well. That gives time for the liquid to become a gel and decreases the possibility of residual liquid coming in contact with the dermal layer of the skin which is what causes the inflammation. An ice pack afterwards also helps a lot.

One other thing, while it seems you aren't paying much for Firmagon, maybe consider getting it at a public hospital. My husband does and it's free. We're also in OZ."

healthunlocked.com/advanced... From the following Post:

responses=148538809&utm_source=notification&utm_medium=email&utm_campaign=email_individual_response

[MamawV in reply to dhccpa]

I wouldn’t want to add another med if Lupron is working and the PSA is that low. My stage IV hubby has only been on Eligard quarterly shots as surgery or chemo weren’t options due to extensive mets. His PSA started to climb in January so he tried the Xtandi for a few months but it failed and PSA is now 145.

[dhccpa in reply to MamawV]

I hope he finds a solution. This battle goes on and on.

[Seasid in reply to MamawV]

Why chemotherapy isn't an option? You can always stop if you have side effects. My chemotherapy wasn't a big problem for me. See chemotherapy from Fred Saad:

urotoday.com/journal/everyd...

[swwags in reply to tango65]

Where did you find that it only applies to newly diagnosed? Is it not possible that those who are on ADT and have had Chemo in the past, can add this to their regimen?

[tango65 in reply to swwags]

The population studied were newly diagnosed patients. They did not included patients with BCR and metastases. The results applies only to the population studied.

[swwags in reply to tango65]

What you're saying makes sense but if both ADT, say Lupron and Darolutamide are both approved by the FDA as a standalone, why would they not be approved as a doublet?

[tango65 in reply to swwags]

One needs to prove that adding the drugs after having started one months before or in BCR patients, offers a survival advantage. It may not offer a survival advantage and it may cause more adverse events.

[dhccpa in reply to tango65]

Yes, that seems to be my MO's position.

[Seasid in reply to swwags]

Nubequa was until recently only approved for the CRPC.

Nubequa is now approved for the hormone sensitive prostate cancer.

The clinical trial was performed with the combination of ADT+Docetaxel+Nubequa in a hormone sensitive setting. The FDA can according to the law only approve the drug in a setting performed in a clinical trial.

Hope this helps.

[Islandboy2021 in reply to swwags]

I would like to know the answer to this as well.

[KocoPr]

I am HSPC and had it added 50 days into lupron treatment. This trial also didn’t include darolutamide and adt combined with no docetaxel.

And im not newly diagnosed. I was dx in 2013.

[dhccpa in reply to KocoPr]

Thanks, some docs get hung up on the idea that you either start both at beginning, or you wait until the first one fails. My MO and I discuss this regularly, and I think he may switch gears.

[Seasid in reply to dhccpa]

"My MO discuss this regularly, and I think he may switch gears."

Can you please explain this to me better?

[dhccpa in reply to Seasid]

Should be "my MO and I".

He wasn't my MO at the very beginning. His general attitude is that I've been so stable that he hesitates to add a second treatment at this point. I think if I insisted, he would go along, but I'm still thinking about it.

[KocoPr]

We would have started them together but needed to get it approved first then saw that it would cost me 3K/month so pursued patients assistance and ended up getting it free through MGH pharmacy.

[Spyder54 in reply to KocoPr]

Note the new law that max is $166/mo for any pharma giving access to all. Game changer. Big Pharma will see more volume. Less profit margin

[swwags]

For those on Medicare (Part D), this is a tier 5 specialty tier drug. I have Medicare, not private coverage aka Medicare Advantage but I believe the personal cost incurred are the same or close to each other with either plan.

At any rate, the drug is $13k per month. After my deductible of $480 I pay 25% coinsurance up to $7050 and then pay 5%, or $650 per month following that or roughly another $5850 per year. Cost per year = $13,380

[KocoPr in reply to swwags]

What hospital is your doc affiliated with?You can pursue patient assistance via manufacturer or see if your hospital has a grant program. I got a grant via my hospital pharmacy

[Spyder54 in reply to swwags]

I have been circumventing Plan D w GOOD Rx on Zytiga at $212/mo