Can Nubeqa (Darolutamide) be used instead of normal ADT drugs for localized PCa?

[Mike58]

Hi all.

Australia has just given the green light to lower the cost of this so-called wonder drug from a staggering $40K (AUD) to a low $30. It seems that this drug has fewer side effects than the usual ADT drugs and from what I can gather does a pretty good job of preventing the growth and spread of PCa.

So my question is; Can we use this drug in place of ADT when we also use RT to get on top of localised PCa?

Also, has the USA subsidized this drug to the extent that Australia has?

Thanks all.

health.gov.au/ministers/the...

[GP24]

The Embark trial showed that Enzalutamide monotherapy works better than ADT only, but Enzalutamide + ADT works even better. urotoday.com/conference-hig...

I think the results with Darolutamide would be similar, if there would be a trial available. I would take ADT + Darolutamide for six months after radiation.

[Mike58 in reply to GP24]

Thanks GP24, It looks like TA has added some further info to all this, with a trial currently operating in Australia. I will check it out.

All the best with your pathway to full recovery.

[Tall_Allen]

There are no data on darolutamide monotherapy, and the EMBARK trial showed that enzalutamide monotherapy is inferior to the combination with ADT. I doubt it would be different for darolutamide.

There is a trial in OZ of darolutamide+ADT+EBRT in very high risk patients:

clinicaltrials.gov/study/NC...

Drugs are free on trials in the US, and I would guess in OZ too.

I don't know that it has fewer side effects.

[Mike58 in reply to Tall_Allen]

Thanks T_A. I'm doubtful that I'm a candidate for this trial but will ask about it anyway. The enormous complexities of all the different drugs, treatments, diagnoses, - I have no idea how you keep up with it all, but we are thankful you do!

[PCaWarrior]

Clinical trials show that Nubeqa has fewer side effects than Erleada or Xtandi.

If you can tolerate ADT+Nubeqa, this combo might be favored. I can't tolerate ADT (with or without any other drugs). I have never tried Erleada but can't tolerate Xtandi for more than a few weeks. However, I can tolerate Nubeqa, Zytiga, and Casodex monotherapy.

My MO's clinical experience is that most men in her practice tolerate Xtandi better than Nubeqa. She told me that I am one of the few men in her practice who validate clinical trial results.

Discussing EMBARK monotherapy:

"Neal Shore: Yeah, so the enzalutamide monotherapy arm, which was a key secondary endpoint also, met its endpoint of statistically significant. I will note that in the primary endpoint arm, the combination of ENZA LHRH versus LHRH alone, in addition to that hazard ratio being 0.42, that P-value was a 0.001 in the monotherapy arm. This was also statistically significant with a P-value of 0.005. The hazard ratio of monotherapy ENZA versus LHRH alone was 0.63, so a 37% reduction in the risk of metastasis or death in that arm as well."

Enza+ADT>Enza>ADT

Intermittent therapy was used.

urotoday.com/conference-hig...

[Mike58 in reply to PCaWarrior]

Thanks for your reply. Your comments and that of Neal Shore, just shows the in depth complexity of what we are dealing with. Common folk like me will never get a handle on it all but generally trust our Drs for their "expert" opinions. But it is good to know that plenty of people do understand all this and yet dont have a string of letters after their name.

[PCaWarrior in reply to Mike58]

If you listen to my wife you'll hear lots of strings of letters after my name

[binati in reply to PCaWarrior]

The experience in India of my Medical Oncologist is that Nubeqa has less side effects and generally is well tolerated as compared to Abiraterone and Enzalutamide.

[Ramp7 in reply to PCaWarrior]

Intermittent therapy was used. That aspects intrigues me.