Nubeqa Monotherapy vs Dual Therapy with ADT

I don't remember if there's a similar study in process for Darolutamide (Nubeqa), but the LIBERTAS phase 3 trial currently underway is looking at Apalutamide (Erleada) monotherapy for exceptional responders with metastatic castrate-sensitive prostate cancer. The final results should be out in 2027, with some preliminary results possible at the end of this year.

Older research showed that ADT "holidays" were safe only for patients with non-metastatic prostate cancer, but that was before the availability of second-generation ARSIs (the "-lutamides"). We'll know in a year or two if they're able to rewrite the book on long-term hormone therapy for people with metastatic prostate cancer.

I know a lot of people over at ancan.org That are on Darolutamide Alone and it works great for them.

You would be better off with Orgovyx To get that testosterone down, Darolutamide Does prevent testosterone from working with the cancer to make it grow, but if you have really high testosterone for a long time, it could be a problem and defeat the drug. It could also defeat Apalutamide Quicker than if you were on ADT as well.

After 7 years of ADT, I stopped Orgovyx And just stayed on Darolutamide for eight months. My Testosterone started rising too fast so my oncologist wanted me to go back on Orgovyx. My PSA stayed undetectable.

I know some people with some very serious prostate cancer cases, who are just on Darolutamide, And it’s been keeping them undetectable. The nice thing about it is that it has no side effects for most people. Apalutamide On the other hand does have side effects and can cause brain fog.

My husband has an aggressive case of PC (see bio) and has been on Orgovyx and Nubequa for nine months. For the last six months his PSA has been .04. As a result the doc withdrew the plan for chemo on top of the two drugs. At his last appointment a few weeks ago he suggested the possibility of intermittent therapy and suggested we look at the EMBARK study, which we did. He also mentioned watching the LIBERTAS study.

@ucla2025
What does he mean by intermittent therapy? Stopping ADT can take months before your testosterone comes back. How intermittent would he want it?

If you do intermittent therapy with Nubeqa I would want monthly blood tests For him. An aggressive case can come back quickly. Of course, after a few months of monthly test, you could go to three month tests.

I assume he means dropping the Orgovyx and going monotherapy with just Nubequa while watching PSA. I am making this assumption having read about the EMBARK and LIBERTAS studies. I believe those studies suggest that patients who drop to PSA <.2 after six months on ADT + ARPI could go to only the ARPI to improve their quality of life, with close tracking of PSA of course. Am I missing something?

@ucla2025
Intermittent usually means stopping and starting. You definitely don’t get much benefit doing that with ADT.

I would ask the doctor what they specifically were thinking about.

Nubeqa alone works quite well and can probably keep the PSA undetectable for a long time. It would be nice if the doctor would let him do that.

@jeffmarc wrote " The nice thing about [Darolutamide] is that it has no side effects for most people. Apalutamide on the other hand does have side effects and can cause brain fog."

I think you mean specifically cognitive side-effects. Darolutamide has many general side-effects (as is the case for all ARSIs):
https://www.mayoclinic.org/drugs-supplements/darolutamide-oral-route/description/drg-20470011
The instance of cognitive side-effects seems to be in the low single digits for Apalutamide, percentage-wise, but if you're one of the unlucky ones, switching to Darolutamide is an option.

@northoftheborder
While there may be listed side effects for Darolutamide, I have heard from a couple of dozen people at least, that are on it, and have found no side effects at all. I have heard from a couple of people that had side effects, but it was after stopping and starting again. There were a couple of cases where people reduce the dosages of it, But the side effects they reported were from ADT, more likely, since they were on both.

If you were to attend an Ancan.Org Advance prostate cancer meeting you would hear them constantly telling people to switch to Darolutamide. Listen to one of the previous sessions and you can hear it. That’s because it works so well.

I didn’t bring it up, but fatigue is a commonly reported problem with Apalutamide, Not really a problem for most people with Darolutamide.

I started the patch on 6/17 and Zytiga/prednisone on the night of 6/26. I didn't feel great on 6/18 (stomach ache, bit of nausea, pressure in my head, fatigue), but that was the worst of it. The pattern seems to be that I feel the head pressure/fatigue the morning after starting a new set of patches (twice a week), so it's pretty clear it's a side effect of the patch, not the Zytiga (and, of course, because the first time it happened I wasn't yet on Zytiga). However, biking seems to fix the symptoms incredibly quickly. I imagine any vigorous exercise would have the same benefit.
Good luck!

Well this is the same question I was going to post here on the forum. Started Orgovyx and Zytiga with prednisone Feb of 26 with a PSA of 55 and T of 413. 4 months later (June 26) PSA 0.28 and T of 1. Convinced the MO to start me on Nubeqa June 17 which I did, slowly weaning my self from the prednisone (from 5mg daily to 2.5 then 2.5 every other day). Now Im thinking: Why take Orgovyx if the Nubeqa mechanism is to inhibit the cancer cells from using testoserone? Can I have my cake and eat it too? Lol. I will have new numbers July 15 and will be reading and researching the trials mentioned here in this post and elsewhere untill then. Probably wait for August numbers then decide what to do.....Take Orgovyx every other day? Then wait for September numbers? Quit taking Orgovyx altogether and see what the September numbers reveal? The side effects of ADT has certainly raised its ugly head: hot flashes every hour, insomnia. I have lost about 10 pounds (now at 190, 6 feet tall) muscle loss I am sure. I exercise and work physically from dawn to dusk but am losing ground in the fight to stay fit and strong. Sex is not an issue, I left that behind several years ago. I just want to keep my bones dense, my body strong and be mentally fit for a guy with GS 8, multiple mets with osteopenia.
What do you think? Start my own little monotherapy trial in 2 months? See where the numbers take me? What do I have to lose except perhaps starting Pluvicto a couple months early? The Dr said Pluvicto was in my future, maybe in a year or two, I guess when the Orgovyx and Nubeqa quit working. I sure would like to feel good for those 2 years, Orgovyx free. As always, thoughts and opinions are most welcome. Thanks for reading my post, I will be reading yours!