Phase III Checkmate Trial Decision Help

[Johnyjack]

My MO wants me to enter the phase III Checkmate trial. I'm curious what folks think about going into the trial. I ask because this is a big commitment with a fair share of misery. My stats are: age 65, diagnosed stage IV PC in 2/2020, ADT & prednisone since 3/2020, 6 rounds of chemo 7/2020-11/2020, added Zytiga in 12/2020. In this past May my PSA was 0.05. In September it was 0.15...in other words I've moved from castrate sensitive to castrate resistant. I need help making this decision and would appreciate your thoughtful answers.

[tango65]

IMHO, I will go with proven treatments at this stage. You can get Cabazitaxel chemo, or perhaps even better try to get into a Lu 177 PSMA trial. This PSMA therapy has shown to prolong life and it has no significant side effects unless there is diffuse infiltration of the bone marrow by the cancer. It may be more effective than Cabazitaxel in controlling the cancer.

There are several clinical trials:

clinicaltrials.gov/ct2/resu...

There are also trials for Ac 225 and thorium

clinicaltrials.gov/ct2/resu...

clinicaltrials.gov/ct2/resu...

If you decide to go for Lu 177 PSMA and you do not qualify for the trials, you could get the treatment abroad, if financially possible. There are many places in Europe and the less expensive seems to be in India.

[Tall_Allen]

I guess you mean the Checkmate 7DX trial which gives Docetaxel±Nivolumab. Did docetaxel work well when you took it before? Was it tolerable? You do not meet the definition of castration resistance to qualify, but you may have demonstrated it before you went on Zytiga.

[Johnyjack in reply to Tall_Allen]

Yes Checkmate 7DX is phase 3. My MO is the lead investigator and according to him I qualify as castrate resistant because my PSA of 0.05 in May, PSA of .11 in august and .15 in September. I was considered castrate sensitive after chemo and before starting Zytiga. From what I understand I tolerated docetaxel pretty well. Since it's a double blind trial I have a 50% chance of being either in the experimental group or control group. Either way it's a lot of extra scans and blood draws, along with all the other fun stuff that goes with getting chemo. Just trying to understand how to think about it.

[Tall_Allen in reply to Johnyjack]

Either way you get docetaxel. The experimental group gets Nivolumab too.

It's certainly up to him to let you in the trial, although you do not meet their definition of castration resistance. They are following the PCWG3 definition which states (if you do not have radiographic progression) "1.0 ng/mL is the minimal starting value if confirmed rise is only indication of progression" They allow rapid PSADT but it requires 3 values over 0.1 at least 4 weeks apart.

[EdBar]

Good time to do Provenge while PSA is low then go from there, that way you’ll have that working for you too although you can’t track it’s effectiveness by your PSA. In trials those who underwent Provenge who had a PSA of less than 5 and were asymptomatic saw an increased survival time of 14 months.

Ed

[j-o-h-n]

YOU'RE WELCOME!!!

Good Luck, Good Health and Good Humor.

j-o-h-n Tuesday10/05/2021 7:22 PM DST