Is Nubeqa a suitable substitute for Zytiga?

[Pianodude]

My PSA has been gradually going up from a low of 0.3 in November to 1.0 currently. My MO wants to start me on Nubeqa in addition to my Orgovyx regimen. He reasons that Nubeqa has fewer cardiac side effects, which is a concern for me. I went to the Nubeqa site and it says that it is for castrate-resistant, non-metastatic PCa. What do you all think?

[tango65]

If the PSA has been increasing when the cancer is treated with ADT and Zytiga, the cancer is castration resistant. Some will require the PSA is 2 or higher.

Darolutamide/Nubeqa could be tried to see if it works. It may work for a short time since there may be cross resistant among these new anti androgens.

It seems it may be better after the failure of one of the new anti androgens to do chemo than start other new anti androgen.

If the cancer was metastatic by bone scan or CT scan, then your doctor will have to become creative to get the insurance to pay for Darolutamide which has been approved for non metastatic castration resistant cancer. Just some things to discuss with your doctors.

[Pianodude in reply to tango65]

I have just been on Orgovyx. We talked about adding Zytiga, but my MO is concerned that the cardiac side effects may be an issue. That is why he is pushing Nubeqa.

[tango65 in reply to Pianodude]

The cancer is castration sensitive. Nubeqa is approved for non metastatic castration resistant cancer.

Your doctor may get the insurance to pay for Nubeqa (around 14 K a months) due to the cardiovascular problems.

The other anti androgen, apalutamide and enzalutamide may cause hypertension which could be a problem for a patients with cardiovascular problems. Nubeqa is less probable to cause hypertension.

There are not studies comparing nubeqa with zytiga, but all these new anti androgens are very effective in controlling the cancer for a while.

[GP24 in reply to Pianodude]

I would wait for the PSA value to get above 2.0. Then you are castration-resistant and the insurance will pay for the Nubeqa. Tango is right, there is very likely a cross-resistance with Zytiga, so I would not start with that now.

[GeorgeGlass in reply to GP24]

my psa is .11 and insurance approved Nubeqa last week. I realize your post was six months ago. FDA is going to probably approve Nubeqa for other categories like metastatic and sensitive etc.

[GP24 in reply to GeorgeGlass]

Yes, it will. But only when phase III trials show a benefit. I am not aware that such trials will report results soon. Except Arasens, but that requires chemo.

[GeorgeGlass in reply to GP24]

I did read this: healthunlocked.com/redirect...

[GP24 in reply to GeorgeGlass]

I mentioned the Arasens study in my post. In the article you provided a link for, it says "Based on the results of ARASENS, we conclude that darolutamide in combination with ADT and docetaxel should become a new standard of care for the treatment of patients with metastatic hormone-sensitive prostate cancer,"

So this is a triplet therapy of ADT, docetaxel (chemo) and darolutamide. I hope darolutamide will be approved for just ADT combined with darolutamide in hormone sensitive PCa, but this will be a long shot I guess.

[GeorgeGlass in reply to GP24]

Maybe s long shot in the short term but i think it will be approved without chemo in the medium term. It seems to act against the ARs similar to the other ARs that are already approved without chemo.

[GP24 in reply to GeorgeGlass]

I agree but the FDA needs an expensive phase III trial to approve that. And that trial takes a long time.

[Teacherdude72 in reply to GP24]

I have been on Nubeqa and monthly Lupron since May of 2021. PSA <0.02

[Savoy in reply to tango65]

Insurance companies suk. Sorry about that, a little breakthrough anger there.

[GeorgeGlass in reply to Savoy]

my psa is .11 and insurance approved Nubeqa last week. I realize your post was six months ago. FDA is going to probably approve Nubeqa for other categories like metastatic and sensitive etc.

[BruceSF]

Actually, since your PSA rose from 0.3 to 1.0 while taking Orgovyx, then you are definitely “castrate resistant”.

Also, since you don’t have conventional scans showing mets, then you are “non-metastatic” for insurance purposes. So, you are a perfect candidate for darolutamide/Nubeqa!

Nubeqa has the best adverse event profile of all the second-generation drugs, so your oncologist is giving you excellent advice!

Finally, since you have not previously taken Zytiga or any other 2d generation drug, you will hopefully get excellent results from Nubeqa and enjoy at least a few years of control, and if you do subsequently advance to a metastatic state then treatments like Lu-177, Provenge, or something currently in trial will be available to you.

[Hidden]

I like your Mo . It sounds right to me . It seems like he’s on top of it? Good luck . Let this new stuff push it way down .

[Tall_Allen]

All GnRH antagonists (Firmagon or Orgovyx) have lower cardiac side effects. I haven't heard that Nubeqa has lower cardiac side effects. Good luck getting insurance approval.

[GeorgeGlass in reply to Tall_Allen]

I read the Nubeqa study results. The cardiac event % was very close to the placebo group. Maybe because it does not cross the blood-brain barrier. Zytiga and other 2nd line ARs had slightly higher cardiac side effects but I don't recall the numbers off the top of my head.

[wagscure259]

I have been on darolutamide for 10 months now without any cardiovascular events with a history of HTN and coronary artery disease. My MO @ MSK never mentioned prescribing it because of reduced cardiovascular side effects. In the ARAMIS trial there was a 3.2% incidence if ischemic heart disease and a 1.9% incidence of heart failure. I had a slowly rising PSA while on Lupron and bicalutamide. It brought my PSA down to undetectable within a month. Depending upon your income you may apply for Bayer’s financial assistance program. Best wishes for a long term efficacy of treatment with the darolutamide.

[GeorgeGlass in reply to wagscure259]

Six months later, how are you doing, and what were your side effects? Were side effects worse in the first month or so? How about impact on white blood cells, platelets and other blood measurements? How about blood pressure or other possible side effects? I saw the Nubeqa trial side effect %'s but thought I'd ask some of the guys on this site as well.

[wagscure259 in reply to GeorgeGlass]

Bloodwork remains excellent. Only side effect is fatigue and only occurs if I don’t space the BID dosages far enough apart. I was concerned that I wasn’t eating enough to gain the 2-2 1/2 times absorption rate while taking it at 8 am and 8pm. I consulted a pharmacist at Bayer ( the developer of darolutamide) recommended I take it at breakfast and dinner. This means I take the 2 dosages about 7-8 hours apart- and hence the fatigue. I questioned whether the fatigue was a sign of effectiveness and no one could definitively answer that. My next PSA will be August 19th. The best to you.

[GeorgeGlass in reply to wagscure259]

Thanks wags,

So, not you take one at 8am and one at 8pm. Both with food?

What did you choose for adt? Teacherdude said better advised lupron but i haven’t been able to confirm that. Why would they recommend lupron over orgovyx?

Great to hear that your blood work looks good. Do you eat vegetarian or do you eat everything?

[wagscure259 in reply to GeorgeGlass]

I’ve been receiving Lupron injections since the beginning of 2013 and continue today. I will withstand the fatigue until 8/19 and take at breakfast and dinner. I eat everything. I was vegan for 10 years, 5 post diagnosis and still saw a progression of disease. I believe exercise and low body fat to be most important and honestly I don’t want to deprive myself of what I enjoy

[GeorgeGlass in reply to wagscure259]

Sounds good. Good luck at your next appt. Let us know how things go.

[HopingForTheBest1]

I am on Neulasta as part of my chemo treatment to boost white blood cell count made in the bone marrow. After my first injection the count has definitely improved.

[CAMPSOUPS in reply to HopingForTheBest1]

Hi Hoping For. You are so on top of things that it was probably a typo on your part.Just in case though: for improvement in WBC production from marrow almost always

Generic Name: pegfilgrastim

Brand Name: Neulasta

Is given during chemo. I had a shot of it the day after each chemo infusion.

[HopingForTheBest1 in reply to CAMPSOUPS]

You are correct. Thanks for letting me know. I did edit my response. 😀👍

[GeorgeGlass in reply to HopingForTheBest1]

This post was about Nubeqa, sometimes mixed up with Nuelasta, but while we are on the topic, did you get very low WBCs from the chemo or did you take the Nuelasta as a preventative measure, just in case?

[HopingForTheBest1 in reply to GeorgeGlass]

Yes to both.

[Purple-Bike in reply to HopingForTheBest1]

This is off the thread but let me ask - how much did WBC and in particular lymphocytes improve? Any side effects from Neulasta?

[Joey40]

I was just diagnosed with metasatic castrate resistent Pca.My doctor put me on Nubequa starting Jan 5th. Medicare is paying. Will have my first blood test in a few weeks to check on PSA. No side effects.

[GeorgeGlass in reply to Joey40]

No side effects Joey? That's awesome!

Since this post was six months ago - how are you doing now, and what were your side effects the last six months, anything pop up? Were side effects worse in the first month or so? How about impact on white blood cells, platelets and other blood measurements? How about blood pressure or other possible side effects? I saw the Nubeqa trial side effect %'s but thought I'd ask some of the guys on this site as well.

[Joey40]

Sorry i made a big mistake in my post. Medicare is not paying, the VA is paying for my Nubequa. Sorry if i got everyone excited.

[GeorgeGlass in reply to Joey40]

I cant tell if tricare or the VA authorized mine last week. Do you pay anything? They quoted me $38 so I assumed that meant tricare.

[teacherdude70]

NUBEQA is for castrate-resistant, non-metastatic PCa. If metastatic pca it would seem the wrong med. I have been on it for 9 months plus Lupron and PSA is undetectable. Only side effect is weakness. Offset some by hitting the gym daily.

[GeorgeGlass in reply to teacherdude70]

It looks like its effective against metastatic too. Let's face it, a good amount of people who are metastatic, are treated like they are non-metastatic because the traditional CT scan is the standard of measurement. cancer.gov/news-events/canc...

It's good to see that Nubeqa was working well for you? Six months later, how are things now? did you ever have problems with your blood counts on WBC, platelets etc? Blood pressure? What time do you take it, any recommendations? With or without food etc?

I'm probably going to start on it this week.

[binati]

I am NMCR and I've been on Nubequa for over 3 months. Till now I have really not had any side effects. There is some slight reduction in stamina. My pulse rate goes up faster when I do cardio so I guess you could say less stamina. I do exercise a fair amount daily including walking 60 km weekly and weights.