Would like Opinions about Continuing on Pluvicto Trial

[spolyu]

Dgnsd 2020. Had radiation for 2 months and was on Abiraterone for 2 years. Abiraterone stopped working. PSA started to rise to 9.3. I have been getting Cat Scans, PSMA and Bone scans. I enrolled in Pluvicto trial in September 22. I wasn’t selected for Pluvicto until the scans get worse. I was put on Std of Care with Xtandi. I had to stop Xtandi due to allergic reaction with a rash. The PSA did improve to 8.There is no other Std of Care Option available. If I want to stay in the Trail, I have to continue to be scanned every 8 weeks until the scans get worse without any Cancer treatment. I am thinking if it makes sense to continue the waiting game or to try a different medication which would cause me to drop out of the trial. Iwould appreciate your thoughts.

[GP24]

I assume you take part in the PSMAfore trial. It says for the control arm: "For participants randomized to the ARDT arm, the change of ARDT treatment will be administered per the physician's orders. Best supportive care, including ADT may be used." So you could change to Apalutamide or Darolutamide while staying in the trial.

clinicaltrials.gov/ct2/show...

[spolyu in reply to GP24]

I was taking Arbiratone and it stopped working. The only two drugs that are allowed in the trial for standard of care. is Ab abiraterone and Xtandi. I had an allergic reaction with a rash with Xtandi. I was forced to stop taking it. So my choices are to continue to wait and see and take scans every eight weeks with no cancer treatment or to leave the trial and get a new medication

[GP24 in reply to spolyu]

What is the name of the trial?

[spolyu in reply to GP24]

Protocol NO. CURLu177PSM0001

[GP24 in reply to spolyu]

This is a difficult decision. The Vision trial with Lu177 by Novartis had a very similar protocol and this was critized because the patients in the control arm were allowed to take Xtandi or Abiraterone only which is effective to a short period only when you are resistant to Abiraterone. If you would take Xtandi your PSA value would rise again in about three months and you would have to make the same decision as you have now. Nobody knows if radiographic progression will reduce your overall survival now. I would just wait until I can cross over to the Lu 177 therapy and hope that this will decrease the progression then.

[spolyu in reply to GP24]

Thank you

[Tall_Allen]

Aren't you taking Lupron? Docetaxel would be a good choice now.

[spolyu in reply to Tall_Allen]

The only Std of Care options available on this trial are Abiraterone and Xtandi. Abiraterone stopped working after 2 years. I tried Xtandi for a week and was forced to stop the medication due to a severe rash. So I can continue to be without cancer treatment until my scans show me getting worse. I would be getting scans about every 8 weeks . Or I can leave the trial and try a different treatment. Please share your thoughts. Ty

[Tall_Allen in reply to spolyu]

I just shared my thoughts.

[noahware]

Personally, I would stay in the trial. My feeling would be that there is only a real urgency to begin a new treatment if the scans show progression... and if the scans show progression, then the "new treatment" will be Pluvicto!

And this is coming from a guy who was in a Pluvicto trial who appears to have failed that treatment. What I really wish I had done differently was 1) insisted on PSMA-PET to help monitor the treatment after it began, and 2) insisted on an FDG-PET prior to starting, to help see how likely success might be.

These two things were of course NOT part of the trial protocol. So I have no idea if insurance would have covered them, let alone if those running the trial would even have allowed them. I took my chances, but seemed to have a limited response (aside from it making me more anemic).

So without these scans, my feeling is that doing Pluvicto is a crap shoot. Just because some of your mets have enough PSMA-avidity to qualify for the trial does not mean the treatment will succeed.

Being this is an uncurable disease, and one of the most powerful resistors to treatment in the world and could blow your head clean off, you've gotta ask yourself one question: "Do I feel lucky?"

[spw1 in reply to noahware]

This is a good response. My husband was selected for a trial and told that he had PSMA avid cancer. We decided to try Lu177 first and went to India to get the treatment. Prudently, they did FDG and PSMA scans. There was a lot of discordance and FDG was more avid than PSMA. The trial teams do not look out for the patient's best perspective overall. Can you get these scans independently to help you decide?

[noahware in reply to spw1]

Well, that's a good question... I didn't do it, but I wish now that I had tried to. I have to agree that it seems the trial team can have the trial, and not the patient, as their primary focus.

[spolyu]

Thank you

[Fightinghard]

i was in a Pluvecto trial. Completed 3 of 4 rounds then scans showed progression so I was out. Not a silver bullet as I had hoped for. Now on SOC chemo.

My opinion would be to follow TA’s suggestion above and go to chemo now. Waiting sounds like a risky idea to me. If needed, you should be able to get the Pluvecto after chemo. The FDA approved this use AFTER chemo, so trial should not be necessary.

[spolyu in reply to Fightinghard]

Thank you

[tango65]

I would stay on ADT and in the trial and get the Lu 177 treatment. Lu 177 is as good or better than chemo and has less negative side effects than chemo unless the cancer is infiltrating the bone marrow.

[spolyu in reply to tango65]

Thank you

[spolyu]

Thank you