Clinical trial ODM-201

[Bobkar]

Has anyone had any experience with ODM-201 clinical trial . My brother is to start this week. Have read all the info but it’s nice to hear from someone who has first hand experience.

[Hidden]

Hi:

I do not have experience with this drug and/or the trial i just wonder why is he going to a placebo trial when the FDA just approved apalutamide an anti androgen which offers a survival advantage. Just curious. Did he fail enzalutamide and/or apalutamide?

[Bobkar in reply to Hidden]

No he has had no treatment yet except lupron shot and casidex.I will call and ask about this. He just had first appt Friday at Moffitt cancer center and it was so overwhelming and we are just grasping for any hope. Thank you will call and ask this question.have not signed any papers yet. As I understand it,he will get all the standard treatment but this pill can also extend his life. double blind trial that he has 50% chance of getting the pill .

[Cynthgob in reply to Bobkar]

My husband is in the trial. Same treatment as your brother. He’s just finishing chemo tomorrow. We picked this trial as we thought it was the best choice. He’s a Gleason score of 8 and many many bone mets. He’s finally out of pain and seems to have managed to get through the chemo . Hair loss and damaged nails . But he’s still standing.Had lupron and casidex as well.

[Bobkar in reply to Cynthgob]

My brothers Gleason score is 8 also with the bone Mets. Your husband is giving me some hope! Did you ice the fingernails before or after chemo? Pray your husband continues his path. Please keep me updated. Thank you

[Cynthgob in reply to Bobkar]

No we didn’t as it didn’t start until the end. Will ask today and see what they say. We are on sixth chemo today . Just praying all goes well

[Bobkar in reply to Cynthgob]

Praying

[Bobkar in reply to Cynthgob]

How is your husband doing, my brother is waiting for the paperwork to sign for the trial and then more scans, blood work, chemo is delayed about 5-6 was until the trial pills are taken. Getting anxious seems like things are moving slow and we want to hurry up and start,I guess there is a lot of protocols to go thru.

[Cynthgob in reply to Bobkar]

It took us awhile to get things going too. But the thing they reassured me is that he was already in treatment as the hormone shots and pills are working against the cancer right now. We finished chemo Tuesday and now he has the flu. I cannot imagine how bad he must feel. Lupron shot, chemo and the flu. We just got home from hospital now.

[Tall_Allen in reply to Hidden]

Apalutamide was only approved for castration-resistant prostate cancer that is not metastatic, a relatively rare indication.

[Bobkar in reply to Tall_Allen]

Yes , that is also what we were told. Thank you. He is definitely going on the trial just waiting for more scans, paperwork etc it just seems so long to wait even though he is receiving the lupron, casidex.

[Tall_Allen]

If this is the ARASENS trial, it is a really good one. BOTH groups get docetaxel, which has already been proven to extend survival in men who are detectably metastatic and hormone sensitive. If he is in the darolutamide placebo group, he will still be eligible for other therapies later. For a discussion of his options and other clinical trials, see:

pcnrv.blogspot.com/2017/06/...

[Bobkar in reply to Tall_Allen]

Yes this is the trial,, pray it works.

[Cynthgob in reply to Bobkar]

How is your brother? Has his psa dropped to 0? I am worried as my husbands is still hanging around 7. Did he finish his chemo? Pray that it worked.

[Bobkar in reply to Cynthgob]

Cynthgob, I just replied to another message that you posted and then I saw this message. That is so strange we must be on the same pathway!!!! I was just telling my sister earlier that I was going to ask if your husband had his F/U scans after last chemo.praying they gave you some relief. My brother has one chemo left then 3 wks later repeat all scans which is good since we thought it would be 3 MONTHS later. PSA down 0.5 Alk Phos 40 still has shoulder pain and dr and trial said he could get it injected and not effect trial. Then he was told will only stay on trial and lupron for now....hope and pray these 2 men will be well. Please keep me updated.

[Cynthgob in reply to Bobkar]

Yes he had his follow up scans and all looked stable. His psa is 7.0! I’m not really happy with that. They are doing scans sept 12 . He is doing pretty well. Able to work out . I think if he was on odm he would be at 0. So am anxious about September . We are planning trips right now and just trying to get as much out of each day that we can. Everything I read about psa makes me worry that he hasn’t had better results .

[Bobkar in reply to Cynthgob]

Completely understand. The only comfort that has helped is the oncologist and trial drs. Have said that on this trial it is significant when your PSA is so high to start with and does respond and quickly drop that that is also one of the grading tools that they use to show progress. Ex. Brothers was around 2800-200-0.5 somehow there is a formula that is used to determine effectiveness so your husbands may not be in NORMAL range yet but is progressing.