Lu-177 "Vision" trial NCT03511664 Protocols

[Fairwind]

Does this sound a little strange to anyone except me ?

"Detailed Description:

Patients with PSMA positive scans will be randomized in a 2:1 ratio to receive either 177Lu-PSMA-617 plus best supportive/best standard of care or to receive best supportive/best standard of care only. 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."

"

COSTS

"Lu-PSMA will be provided free of charge in this study to you. The administration of the radionucleotide will be billed to your insurance company. Tests and procedures that are done only for the study will not be billed to you or your insurance company.

You or your insurance company may be billed for all standard medical care given during this research study, including best supportive/best standard-of-care in this study. You may want to talk with your insurance company about its payment policy for standard medical care given during a research study. If your insurance company does not pay, you may be billed for those charges. You will be responsible for any co-pays or deductibles as defined by your insurance for standard-of-care services."

It looks to me like half or more of the costs of this trial will be born by the participant !

[FCoffey]

"Lu-PSMA will be provided free of charge in this study to you." I have no idea what Lu-PSMA costs, but I doubt it is cheap. Since the rest is SOC, insurance should cover it for most people.

[Fairwind in reply to FCoffey]

That's my problem..My Medicare Advantage HMO type plan does not cover "out of network" providers. I'm trying to get them to make an exception or to let me use a third party provider for the SOC part...

[Tall_Allen in reply to Fairwind]

They don't make an exception for clinical trials?

[Fairwind in reply to Tall_Allen]

I'm working on that possibility.. So far, responses have been positive.. I offered to pay out of pocket but Medicare rules don't allow that..Or I could drop Medicare Advantage and go back to regular Medicare, which they accept..Go Figure...Can't change plans until November...

[Kevinski65 in reply to FCoffey]

What about , 'Ordinary Medicare' , thith a supplement does it pay?

[tango65]

It is allowed in a clinical trial to charge the SOC cost of treating a patient. They could charge for all the SOC blood tests, SOC medicines such as abiraterone or enzalutamide , lupron etc and for other SOC test such as xrays, ct scans etc. etc. The "trial" and the doctors running the trial do not charge anything. It is the hospital that will charge for all the SOC tests and the SOC medicines that they provide.

I had this problem when I was in a clinical trial for a vaccine in 2007. I complained and they made a courtesy for what Medicare did not pay. Trials conducted at NIH do not charge anything and provide some travel and lodging expenses (you pay them with your taxes).

[Magnus1964]

That is confusing. First, they are allowing participants to take other standard treatments while in the study? It does not make clear what is part of study and what is "best medical care". If the study requires CT and bone scans, is that to be considered standard care or study procedures. No insurance company is going to pay for monthly procedures.

[CJ4J]

In this study, only the Lu-PSMA is free. Hotel is provided and reimbursement for mileage. We are billed for all labs, office visits, ct scans and bone scans.

Have you discussed the Medicare advantage limitations with the trial provider? They may have ways to help you? Our trial provider in Omaha (Dr. Nordquist) is very accommodating.

[Break60]

It sounds like normal practice to me. Basically you wouldn’t pay anything for the treatments under traditional Medicare. Other types of insurance are another matter, each policy having its own requirements.

As to whether your Travel and living expenses are paid it depends on the type of clinical trial and is spelled out by the trial administrator/funder. See new quidelines:

centerwatch.com/cwweekly/20...

[Stegosaurus37]

The rationale is that the Standards of Care is what you'd be getting anyway if you weren't in the trial, so it's really "not part of the trial" (except that it is).

Since my prostate cancer is Agent Orange-presumptive, the VA is providing that part of the VISION treatment. I've been going to the VA for my treatment anyway and there is a close relationship between OHSU and the Portland VA, so that has been relatively smooth.

[Charles4212 in reply to Stegosaurus37]

I am also a VN vet with advanced PC, Can you tell me more about what the VA is paying on this Vision. Are you getting the Lu-177? Thanks. I am a 100% Disabled vet so my VA in Togus Maine pays for everything I am getting, I just failed with Xtiga and started Xtandi yesterday,

[Stegosaurus37 in reply to Charles4212]

The Lu-177 (which I am getting) is paid for by the study. I also get "Best Standards of Care" (ha!) which is Zytiga. The study doesn't pay for that - "you'd be getting that anyway", but the VA does. I also get 100% disability payment.

[Charles4212 in reply to Stegosaurus37]

Thanks

[ronnie1943 in reply to Charles4212]

Hi Charles.. My name is Lynn, my husband will be going for the Lu-177 trial soon, we live in. The states.

Did you have any sides effects from the infusions.. How are you doing and how many infusions did you have? Did you any reaction to the PSMA scan? Any information you could give would be greatly appreciated.

Hope you are doing well?

Lynn Pa.