benefit of taking a break from Lupron and using darolutamide alone?

[Rob1053]

1st diagnosed 2003. RP and psa increase 2005. Radiation and then intermittent till 9/2021. Darolutamide added 3/2022. Present psa .3. Would there be a benefit to forgoing Lupron and using Darolutamide as primary, allowing testosterone to recover and taking a break once it does to allow body to recover from effects of ADT?

[GP24]

You can continue with your intermittent Lupron therapy and use Darolutamide during the holidays. You will feel much better because Darolutamide does not suppress testosterone. This will be very long holidays. I am not aware of a trial that tested this, but some doctors prescribe Bicalutamide during ADT holidays. You can replace Bicalutamide with Darolutamide.

[Tall_Allen]

I don't know if it will give you the break you are after. Darolutamide blocks testosterone in all your cells (except in the brain). There is a clinical trial of the monotherapy:

clinicaltrials.gov/ct2/show...

If you are willing to risk it, you can try it if your MO agrees.

[Rob1053 in reply to Tall_Allen]

thank you for the info

[joeguy]

I took an ADT vacation because of some nasty side effects of the combo of Xtandi/Firmagon. I allowed PSA to rise to over 2.00 so I could be scanned in a PSMA scan trial. The vacation lasted about a year, my T got up to around 500 and I felt great. Shortly after the scan, I started Darolutimide monotherapy (mostly because I was still worried about what happened with Xtandi/Firmagon, and Darolutimide has a very low SE profile). PSA initial dropped to .9, but then started rising. Once PSA had gotten to about 3.0, I started taking Orgovyx along with Darolutimide. This again dropped PSA, but within a few months, it started rising uncontrollably. At that point I entered into the SPLASH trial to pursue Lu177 treatment (that brings us to the present). Recent scans as part of the trial show dozens and dozens of bone mets all over my body, and increased size and numbers of lymph node mets. At the time I started my ADT vacation, I had no mets detectable by CT or bone scan, and only 6 or 7 lymph nodes showed up on the PSMA scan. Was this alarming progression because of my experiment with ADT vacation and Darolutimide monotherapy ??? We will never know for sure, but seems likely......

[Rob1053 in reply to joeguy]

thanks for replying! Haven’t broached the subject with Dr. But your reply helps. May forget it and not mess with success

[Benkaymel in reply to joeguy]

Is SPLASH a double blind trial? Could you be on the placebo arm?

[joeguy in reply to Benkaymel]

no, you either get Lu277 or Zytiga/ xtandi

[Benkaymel in reply to joeguy]

Which did you get?

[joeguy in reply to Benkaymel]

Lu177, but so far after 1 injection its not working..... hoping maybe the 2nd one does something in a couple weeks

[Benkaymel in reply to joeguy]

Wishing you the best with that.

[joeguy in reply to Benkaymel]

thank you

[wagscure259]

I don’t know if anyone can attest to its efficacy as to my knowledge it has never been tested without an anti-androgen. The trial Allen mentioned is in Phase II , and the daily dosage is 1200mg daily as during the ARAMIS trial. If your MO is willing and agreeable you can be a study of one.

[Rob1053]

Thanks, but I may wait until there is a little more study. Would love a break from Lupron, but not in the cards now. LOL> Thank you for responding! Merry Christmas!

[SViking]

Is Darolutamide covered by Medicare/Blue Cross? If you pay out-of-pocket, what is the cost?

[Rob1053 in reply to SViking]

It is covered by my Humana Part D supplement. It is over $3000 per month and I pay $110. Very few additional Side Effects so far. Good luck

[SViking in reply to Rob1053]

Thanks. Did you have to qualify with any special conditions? I just turned castrate resistant and metastatic with bone lesions. Is that now approved by Nubeqa?

[Rob1053 in reply to SViking]

I think it will but insurance must approve

[tarhoosier]

After going on and off zoladex for eight years my onc suggested Xtandi monotherapy. I have been on that monotherapy for 6+years of varying dosage and continue with low and stable psa. It was the MO idea and not mine. Xtandi was relatively new at that time. That MO retired and my current MO says I am the only patient he sees with such treatment. There is nothing unusual about my PCa other than it has always responded well to Zoladex when administered and same with Xtandi.

[Rob1053 in reply to tarhoosier]

thank you for replying. I would love to get off Lupron but cases like yours are rare apparently!

[tarhoosier]

My case is so uncommon that with testosterone in serum of ~600 it is unclear if bone density is improved thereby. Bone resorption is driven by the small amount of estrogen produced at the same time as testosterone in men so I have E2 circulating as well. Does it enter the bone and operate as normal?

Xtandi blocks uptake of T everywhere not just in tumor cells. My psa has circled around 0.1-0.3 during my time. I appreciate the freedom from injections and the convenience of nightly capsules. I had no hot flashes while on ADT so relief of side effects was not what drove this decision. I had been on degarelix+xtandi prior to that last off period as the MO said that was the very best combination he could provide and the resumption of treatment was with Xandi alone which I continue. It may be that you convert to xtandi plus ADT and then later try xtandi alone as was my experience. Not a recommendation, an observation. Speak with your doctor about choices.

[tarhoosier in reply to tarhoosier]

Note: I had mets in 2012 during an off period and they were treaed successfully with RT. That is an important issue that later made xtandi available to me when it was prescribed as the bone mets status was on my diagnosis chart. This may not apply to you. 100$/mo currently as approved drug.