Phase 3 Clinical Trial

[Emmett50]

My husband has a recurrence based on scans including PSMA. The PSMA showed avid at L3 and left lobe of prostate, and inguinal lymph nodes that should be followed.

Paul had biopsies of L3 and inguinal lymph node on 11/7. . We asked for the lymph node to be biopsied at same time as L3 because the inguinal lymph nodes are easily reached. We are awaiting results.

Paul's care plan includes possible participation in Phase 3 clinical trial. He is still hormone sensitive. The last visit notes call the drug Darolamuide but I'm thinking it's not spelled correctly. I would like to research this. Can someone tell me the correct spelling?

He had mapping today for 5 sessions of EBRT of L3. I know I'll have more questions when biopsy results are posted.

Since his diagnosis in December 2017, Paul hasn't read a single thing about PCa. I don't understand that. He relies on me to research and ask the MO questions. I don't mind doing that as I'm someone who believes knowledge is power in advocating for him. However, it's putting the responsibility on me to make decisions. It's not that I shirk that role. Rather, I'm concerned it's denial on his part. He doesn't want anyone to know about the recurrence. I had to argue that our adult son be informed. Do any of you have insight to help me understand?

Thank you! Mary

[tango65]

Darolutamide. It is a very effective anti androgen with less side effects than enzalutamide and apalutamide. It is approved for CSPC and CRPC.You need support from your family. In my opinion they should be informed.

It is a difficult situation since he does not want to do it and going against his will may erode his trust on you, his only advocate and support.

[Emmett50 in reply to tango65]

Thank you! I agree about family support. We talked and he agreed that I could talk to my siblings and his brother. They aren't local but will be support. If his status declines and he or I need practical and present help, we'll talk again. He is a man with many local friends who would jump at the chance to help.

[tango65 in reply to Emmett50]

I wish the best of luck.

[Tall_Allen]

Darulutamide (Nubeqa) is approved for non-metastatic castration-resistant Pca (but he is not castration-resistant), or with docetaxel for newly diagnosed metastatic hormone- sensitive PCa (but he is not newly diagnosed, not metastatic, and docetaxel is not a good idea for him). But sometimes, insurance may approve it anyway.

[Emmett50 in reply to Tall_Allen]

Hi. This is the Phase 3 trial his MO at UC-San Diego is suggesting. My spouse has osteoporosis from his prior ADT course. His MO's tentative plan is for Casodex, a switch from Lupron to degarelix (fewer bone issues) and enrollment in this trial.

clinicaltrials.gov/ct2/show...

He is currently metastatic with L3 lesion that was avid in last month's PSMA. That is the status used by his MO.

[Heykm01]

I am in the Arasec trial shown in your link. I started in Aug. I have been tolerating the meds well, but I came in pretty healthy and have stayed active.

An advantage of the trial is that the meds are free and you get bone and ct scans every 3 months to track progression. It’s also an open label trial which means you are assured of getting darolutamide and not a placebo.

Tango gives a short summary of darolutamide vs the alternatives. It’s easy to google to research this.

[Emmett50 in reply to Heykm01]

Thank you!