Trial or not

[Grateful4this]

After completing 6 rounds of docetaxel end of May 2022, I had clean scans including PSMA PET and my PSA was undetectable. As of my most recent tests, end of Feb, my PSA has already begun to rise slightly. I am just below 1.0 as of last week with increases shown 2 weeks in a row. There is also evidence of possibly 3 new sites of metastases from the NM Bone and CT Scans i took 2 weeks ago. I continue to be on Lupron since discovering my condition in late 2021.

My MO is suggesting nest step as Xtandi, or to enroll in a Phase 1/2 trial that would entail Xtandi in combination with EPI-7386 by ESSA Pharma, ClinicalTrials.gov Identifier: NCT05075577. I am told by my MO that it is a choice and I am not at trial is my only hope stage.

I have also inquired about other trials. I am aware of another phase 1 or 1/2 ( I am unsure) trial that I may be eligible for that combines darolutamide with abemaciclib. I am willing to listen to this but the trial may not begin until April, and scares me because of my lack of knowledge.

Does anyone have any thoughts or insight into these trials, or Xtandi on its own vs in combination.

All responses are greatly appreciated

[Tall_Allen]

Have you had a tumor genomic test that suggested that CDK inhibition (which is what abemaciclib does) might help you? If you haven't yet been treated with a second gen androgen receptor targeted therapy (there's nothing in your profile), you have nothing to lose with the enza±EPI-7386 trial.

[Grateful4this in reply to Tall_Allen]

I had genomic test that didn't show any mutations if I remember. I will specifically ask that question. And you are correct that I have not been treated with 2nd gen therapy. I greatly appreciate your response T_A

[tango65]

Here are some preliminary results for EPI 7386:

prnewswire.com/news-release...

prnewswire.com/news-release...

ascopubs.org/doi/abs/10.120...

[Grateful4this in reply to tango65]

Thank you for this info tango65. Some of this I had read and some is new to me, and all is helpful

[tango65]

I am considering this trial too.

[Hidden]

With stage 4 prostate cancer diagnosis at the onset of a very aggressive cancer, a tumour was partially removed from the spine. With Xtandi prescribed, Psa fell to 0.24. However, 4 pills proved too stron, resulting in a fall. Falls are noted with Xtandi. For about a year and a half taking 3 Xtandi tabs worked before it stopped working. Now trying chemo-docetaxel, with additional spread to liver. I was happy witht he Xtandi as it gove me a year and a half of normalcy, while I walked aided by walker post surgery. If you decide to take Xtandi, montior yourself closely adue to risk of falls with no warning. depending on your situation, I thinkit is worth it. Unfortunately my cancer was silent until it reached stage 4, at which time the bones were engaged. I suspect caught early enough the Xtandi might work for a long time.

[Grateful4this in reply to Hidden]

I did not know that about the degree of fall risk associated with Xtandi. Thank you for the info and good luck to you

[MateoBeach in reply to Grateful4this]

You might check with ene EPI 7386 trial to see if you qualify for the darolutamide +/- EPI 7386 cohort. Darolutamide is a much cleaner drug re SEs than enzalutamide and at least as effective. Personally I would favor that. Less risk of falls, seizures or severe fatigue.

[Grateful4this in reply to MateoBeach]

I will definitely look into this. Thank you so much

[Grateful4this]

I am glad to know others are watching this trial based on early data. your point about the board member is good to know. Thank you

[Hereformydad2022]

my father was on xtandi and it worked excellent for a year. Halting everything. His biggest complaint was hot flashes

[Grateful4this in reply to Hereformydad2022]

Thank you for your reply. I get hot flashes from Lupron and although I am not looking forward to adding or intensifying, as long as I respond to treatment I will deal those side effects. I appreciate it.

[j-o-h-n]

I will be on Lupron (which I've been on for 15 years) and just off casodex last month and will now be on nubequa (darolutamide).

P.s. Only had hot flashes for a couple of months (on and off) when I first started Lupron/casodex.

Good Luck, Good Health and Good Humor.

j-o-h-n Monday 03/06/2023 10:09 PM EST

[Grateful4this in reply to j-o-h-n]

Thanks j-o-h-n. I wish all the same to you. Thank you for sharing your experience