Should go into the OMAHA2a ODM-208 (MK-5684-004): phase 3 trial?

[LakeT]

I had my 3 monthly OC visit last week. Blood test is showing 0.3 up from 0.15 six weeks ago. MO is suggesting that I should go into the ODM-208 (MK-5684): phase 3 trial if PSA rises above 1.0. PSA of 1.0 or above is a entry requirement for the trial, presumable to be sure that my current treatment has failed. The arms of the trial are:

1:Hormone replacement therapy (HRT)+ opevesostat

Participants receive opevesostat 5 mg by oral tablets twice daily (BID) plus dexamethasone 1.5 mg by oral tablets and fludrocortisone acetate 0.1 mg oral tablet once daily (QD) continuously until disease progression. Hydrocortisone 100 mg (oral or intramuscular [IM]) will also be provided to participants for use as rescue medication.

2: Active Comparator: Alternative next generation hormonal agent (NHA)

Participants receive Abiraterone 1000 mg QD by oral tablets plus Prednisone 5 mg BID by oral tablets or Enzalutamide 160 mg QD by oral tablets until disease progression.

The comparator is basically the same as my current treatment with the option of changing from Abiraterone to Enzalutamide.

I’m not sure of my next best move. Financially a trial makes sense and opevesostat seems to have good results so far albeit it seems to be only tested with patients with an androgen receptor gene ligand-binding domain mutation (ARmut, AR LBD). There is only a 50% chance of receiving this drug in the trial and the active comparator feels like I may miss out on current standard of care, whatever that may be and whatever that may cost.

Any advice would be appreciated please.

[God_Loves_Me]

You already have docetaxal in 2022, Have you tried enzalutamide, or apalutamide or darolutamide ?

[LakeT in reply to God_Loves_Me]

Only Abiraterone so far and nothing else suggested yet. I'll research these three for my next discussion. Enzalutamide is an active comparator in the study. Thanks.

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

Here's hoping for good results........ down under the down under...........

Good Luck, Good Health and Good Humor.

j-o-h-n

[MPCa]

I'm signing on the dotted line for this stage 3 study in Australia this week.Nothing else is working & the PSA is now well over 100 with much bone pain discomfort creeping in after 5 years.

Lets hope this knocks it back some.

Xtandi did nothing....

[LakeT in reply to MPCa]

Best of luck for the trial. It is still a couple of months until the trial opens in Auckland.