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Darolutamide Monotherapy

Posted by mmacaulay @mmacaulay, Jun 12, 2025

I’m curious about the FDA’s June 5 approval of darolutamide (Nubeqa) as a monotherapy for mCSPC. My understanding is that the AR blocker would allow higher T than ADT while providing protection against recurrence in metastatic cases that were previously treated with ADT. It may even delay the onset of CRPC. Higher T might improve quality of life.

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jeff Marchi | @jeffmarc | Dec 27, 2025
In reply to @jime51 "@jeffmarc can likely clarify, but it's my understanding that Nubeqa allows testosterone to rise but its..." + (show)
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@jeffmarc can likely clarify, but it's my understanding that Nubeqa allows testosterone to rise but its purpose is to prevent cells' receptors from using it, which means not just cancer cells but all cells. Quality of life may not be much different than on ADT, but Jeff and others have indicated that it has fewer side effects and it is less likely than some to create "brain fog" and affect heart issues. I look forward to others' responses.

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@jime51
Just one point. Nubeqa Doesn’t pass the blood brain barrier, all of the other ARPI drugs do. That means that it does not affect brain fog at all.

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jeff Marchi | @jeffmarc | Dec 27, 2025
In reply to @round5 "@jeffmarc I’m assuming you’re talking testosterones numbers not PSA?" + (show)
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@jeffmarc I’m assuming you’re talking testosterones numbers not PSA?

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@round5
You are correct. It should’ve said testosterone not PSA. When I’m composing messages, I do that sometimes,, but I reread them and normally change it to testosterone. I use voice recognition so I don’t always catch it. I can’t really type Much since I have nerve damage to my right hand.

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