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VISION clinical trial

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Posted 9/28/2019 11:30 AM (GMT -5)
There has been a fair amount of excitement about this clinical trial. https://clinicaltrials.gov/ct2/show/NCT03511664

This is probably the best hope-giving trial out there for guys who are mCRPC and starting to run out of options. I know a couple of other forum regulars here are/were members of the trial, Fairwind, LuvMyDAD, and rockyfords. Well thankfully, it looks like we can add my name to the group as my RO has gotten me into the pool of subjects even after the closing of the trial to new participants last week. Amazing work done by that doctor, Dr. Gay, to continue to push for my inclusion. Now I am finishing scans here and going to have to travel to Indianapolis for the special scan to see if I will make appropriate levels of PSMA for the Lutetium to bind to. Assuming that is good, then I just need some randomization luck to get into the treatment arm and not the control arm. (2 to 1 favoring the treatment arm). As far as I can tell, there is very little that can be done for guys in the control arm...Lupron and a pat on the back.

There seems to be a lot of hope that this trial won't go all the way to the end, that preliminary results will be so good that control arm folks will get the treatment as well, and it will get opened up to the public that much sooner. I don't completely understand the mechanics of it, but there are 2 points sort of built in to allow for that happy possibility.

I hope this thread will give a lasting point of reference for this VISION trial topic.
Posted 9/28/2019 2:26 PM (GMT -5)
Gmoose good luck with this. There is so much hope out there fir advanced cases and it keeps building, seems like daily we hear of trials like this.
I truly hope you get into the treatment arm. Keep us posted.
Posted 9/28/2019 3:53 PM (GMT -5)
Glad you made it into the trial Gmoose and hope you get through the PSMA scan and the randomization process.. Sometimes the politics and the rules and requirements can be maddening..Make sure your insurance is onboard as they will be asked to do some heavy lifting too once you get that first infusion..Keep posting and best of luck to you !
Posted 9/28/2019 5:28 PM (GMT -5)
Gmoose,
Thanks for participating. I’m looking hopefully to the results of this trial.

Good luck!
Posted 10/6/2019 3:35 PM (GMT 0)

Hello, GMOOSE2,

First of all, I'm excited that you may be participating in a new trial. I'm sending you 100% of my support and best wishes.

Second of all, I feel I owe a debt of gratitude to everyone who has helped blaze a trail ... past, present, and future ... by trying a new approach or enlisting in a clinical trial. It's how the scientists learn ... it leads to advances ... and I'm thankful to all.

Keep us posted, GMOOSE2 --- and let us know how you're faring!

Send with my best, from across the miles,
CYCLONE ~ Iowa State University
Posted 10/15/2019 8:40 PM (GMT -5)
Well, very bad luck for me. I got randomized into the control arm which is basically a pat on the back and a hearty "good luck to you, sir". I will probably drop out of the VISION trial very soon so that I can take a round of Cabazitaxel chemo instead. Joy! I hope the rest of you treatment arm guys will continue to post your VISION trial experiences here. I hope to learn a lot and this drug holds so much hope for us guys with seemingly very little hope left. Perhaps I do the travel/treatment thing over in Germany, or perhaps we will get lucky with such great response in the trial here that the drug trial may end sooner so they can allow guys like me to get treatment.
Posted 10/15/2019 9:23 PM (GMT -5)
Moose,
Sorry man, that is tough. It is hard to understand how they expect the control people, who need treatment NOW, to be okay with nothing.

Good luck on your path ahead!
Posted 10/18/2019 2:16 PM (GMT -5)
Sorry you did not get in the treatment arm. At the link to clinicaltrials.gov you provided it says: "Best supportive/best standard of care will be determined by the treating physician/investigator but will exclude investigational agents, cytotoxic chemotherapy, other systemic radioisotopes, and hemi-body radiotherapy. Novel androgen axis drugs [NAADs] (such as abiraterone or enzalutamide) are allowed."
So you could do a rechallenge with Zytiga or Xtandi, but not use Cabazitaxel or Radium 223. However, you could get a gene test for BRCA2 and take Olaparib if you have a BRCA2 mutation.

As long as you do not want to have Cabazitaxel I would stay in the trial. Maybe they allow the control-group to cross-over at some point next year. The current endpoint they agreed on with the FDA is radiographic progression free survival (rPFS) i.e. new mets. See page 62 in this presentation: https://www.novartis.com/sites/www.novartis.com/files/2018-11-r-d-day-investor-presentation.pdf If they can show rPFS, they will get the approval and usually allow the control group to cross-over.
Posted 10/18/2019 8:12 PM (GMT -5)
Great insights, thanks George. BTW, I did rechallenge Xtandi after ending docetaxel and got no response over a period of a couple of weeks.
Posted 10/19/2019 12:30 AM (GMT -5)
I had my third Lu-177 infusion today..For me, it's working very well, my PSA is down to 390 from 2300 when I started..

The "Vision" trial is having a lot of trouble meeting its stated objectives and there are very few patients who stay in the trial after they get randomized into the control group...Their regular MO's can provide more treatment options at lower cost..

Moose, my next choice was R-223 if I failed to get into the Vision treatment arm..
Posted 10/19/2019 2:13 AM (GMT -5)
Fairwind, I was sort of expecting RA-223 to be a next choice, but my RO and MO were both fairly negative about it and both thought Cabazataxel a better choice. Either way I get booted from the control group. Olaparib was suggested by George tonight and I may want to talk that over with the MO. Not sure if it will put the kybosh on the control group or not, and if there is much benefit to staying in the control arm anyway. Will decide towards the end of next week.

Such great guidance here in this forum. Thank you all.
Posted 10/19/2019 6:26 AM (GMT -5)
about 20% of the patients in your situation have the gene mutations that will make Olaparib work for them. So get the two tests (germline+somatic) to see if it will work for you. You will need both tests because 10% are germline and 10% are somatic mutations. The germline test is a blood test, the somatic test needs tumor tissue, e.g. from the biopsy.

As I understand, you just finished docetaxel and now shall begin with cabazitaxel? You need a break. I heard a presentation about Lu177. The doctor mentioned that he thinks a big advantage of the Lu177 therapy is that when done, it provides a break in treatments for the patient. This is an improvement in QoL. Otherwise the patient gets treatment after treatment and suffers from side effects for most of his remaining life.

You could get the treatment in Germany but this will be expensive. You probably need four cycles (Lu177+Ac225 mix) plus PSMA PET/CTs. One cycle costs about as much as one month of Xtandi. Your insurance will not pay for this.
Posted 10/19/2019 11:56 AM (GMT -5)
Before I got into the Vision trial, my last "SOC" treatment was Cabazitaxel..(Jevtana) It worked better for me than the Dosetaxel did with fewer side-effects, especially neuropathy to my feet which was bad with Dose. The Cabazitaxel controlled my PSA for about a year.

This board is specifically for advanced, stage 4 guys. It has lots of information about Lu-177 and AC-225 treatments in Germany. It's somewhat cumbersome to use but it's search feature will dig up all the Lu-177 / AC-225 threads.

https://healthunlocked.com/advanced-prostate-cancer/posts

https://healthunlocked.com/advanced-prostate-cancer/search/posts?query=Lu-177&page=1
Posted 11/19/2019 3:53 PM (GMT -5)
Adding an interesting link stolen from another post... https://www.urotoday.com/center-of-excellence/imaging-center/video-lectures/video/mediaitem/1467-players-brightcove-net2019-09-10-14-49-08.html
Posted 6/2/2020 7:06 AM (GMT -5)

Hello GMOOSE2 ~~~

I always follow your posts.

Last we heard, you didn't get the hoped for path in the VISION trial.

Hoping you are doing your best.

Drop us a line when you can, GMOOSE2. Let us know how you're faring.

Sent with my best, from across the miles,
CYCLONE --- # Iowa State University
Posted 6/3/2020 7:44 PM (GMT -5)
I have been having decent results on Cabazataxel since December, but like everything else before it, that treatment may be running its course. I am going to re ask about Lutetium . My RO had thought he heard something about it may be progressing towards becoming available out of the trial under compassionate use. He is looking into it. I should learn something tomorrow.
Posted 6/6/2020 7:09 AM (GMT -5)

Hello GMOOSE2 - - -

Keep us posted on what you find out, from your next consultation.

Hoping your doctors have some insight, and helpful ideas, as your treatments continue.

The WELCOME mat is always in front of the door here, and we'll leave the front porch light on, for your next visit here.

Sent with all my best,
CYCLONE ~~~ Iowa State University
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