Post-hoc of ARASENS for metastatic hormone sensitive prostate cancer

[Maxone73]

sciencedirect.com/science/a...

in a nutshell:

1 - Deep and Durable PSA Response: The combination therapy produced a significant number of patients achieving undetectable PSA levels (<0.2 ng/ml). Approximately 67% of the patients reached undetectable PSA at some point, with variations based on disease volume—62% in high-volume and 84% in low-volume disease subgroups.

2 - Time to PSA Progression: Darolutamide extended the time to PSA progression substantially compared to placebo, with hazard ratios indicating a significant risk reduction in both high- and low-volume disease groups.

3 - Clinical Outcomes and PSA Suppression: Achieving undetectable PSA levels correlated strongly with longer overall survival (OS) and delayed progression to castration-resistant prostate cancer (CRPC). In particular, undetectable PSA levels at weeks 24 and 36 after treatment initiation were associated with improved outcomes, emphasizing the importance of reaching and maintaining low PSA levels.

4 - Safety Profile: The therapy was well-tolerated, with adverse events aligning with those expected for the treatments used.

[janebob99]

Excellent Summary. Thanks !

[KocoPr]

i love darolutamide.

[Maxone73 in reply to KocoPr]

Let's hope it loves us back!

[Justfor_]

"... importance of maintaining low PSA levels". That's the reason for my preference to a low drug maintenance dosing instead of any on-off intermitent cycling.

[KocoPr in reply to Justfor_]

Is your goal to keep PSA as low as possible?

I worry that i would eventually get castrate resistance thus that is why i do BAT. My way of saying this is to keep the beast fed and happy on T and keep it caged with Daro/ADT

[Justfor_ in reply to KocoPr]

Not as low as possible because I want to know the way things are developing. For this, PSA has to be at the lowest reportable range, that is 0.010 to 0.050. If by increasing Bicalutamide dosage PSA goes down, or alternatively by reducing it goes up, I know it is still doing its job, hence resistance isn't brewing up.

[MateoBeach in reply to KocoPr]

Working great in my modified BAT regimen KocoPr. See my details below in this thread.

[KocoPr in reply to MateoBeach]

I had a temporary setback on my BAT program due to kidney stone snd high Uric Acid which spiked my PSA big time. On Daro/ADT again which dropped PSA like rock. OC and I will readdress at next visit in Dec. my plan is to reset the PSA then try your cBAT again. I will write a post soon on FPC group

[AlvinSD]

Thank you for posting this. I was diagnosed 5/22 and did triplet therapy with darolutamide then finished it off with radiation

Grateful for this community because without it I would have never met Tall_Allen who pushed me to add chemotherapy based on the (at the time) newly released ARASENS trial data.

[MateoBeach]

Darolutamide plus ADT is such a great combo for mHSPC as these results show. This should move the FDA to remove the requirement for concomitant docetaxel chemotherapy for this treatment regimen in those who were not de novo metastatic.

I use Orgovyx plus Darolutamide in my low to no Testosterone phase of modified BAT. Three months of high T, 2400 ng/dL (2-3 x nl) for 3 months then one month on ADT plus Darolutamide. My PSA remains <.015 during low T, and only up to .020 on the high T.

[Rcole727]

Thanks for posting this. Im somewhat confused. I read the ARANOTE trial which I thought evaluated daroluamide and ADT without chemo in patients with high or low volume mHSPC which I thought concluded that ARANOTE and ARASENS demonstrated efficacy benefits with darolutamide plus ADT with and without docetaxel for patients with mHSPC. For myself, my mHSPC is not denovo as I had Proton in 2009 for PC with Gleason 6 and 1 core 7 (3+4). Im currently on doublet therapy- Firmagon and Nubeqa.

[Maxone73 in reply to Rcole727]

I would say that your conclusions are right...where is the confusion? 😀

[Rcole727 in reply to Maxone73]

I was advised that doublet therapy- Firmagon & Neubeqa -is less effective than Triplet therapy even if individual mHSPC is not denovo.

[Maxone73 in reply to Rcole727]

eh, I don't know if there is a direct comparison, plus (luckily for us) the last time both trials were updated, they had not reached median for OS yet (I think also for rPFS, but I should check), for non de novo it seems that they want to keep the chemo card for later

[Rcole727 in reply to Maxone73]

Much appreciate your analysis!

[StayingOptimistic in reply to Maxone73]

I was offered doublet by MSK and I am on vacation for almost a year now.

[Maxone73 in reply to StayingOptimistic]

And how is Psa?

[StayingOptimistic in reply to Maxone73]

Undetectable

[Maxone73 in reply to StayingOptimistic]

Great result!!!!

[gsun in reply to Rcole727]

ARASENS was with Docetaxel. ARANOTE Is without.