Does the Mayo clinic strictly follow the FDA guidelines for Pluvicto?

Hi @rockey99, that is a good question for your Mayo Clinic oncologist specific to your treatment needs.

What you are referring to is often called "off-label use". Off-label drug use occurs when a physician prescribes medication to treat a condition before that use has been approved by the Food and Drug Administration. This may be done in a clinical trial setting as researchers study expanded effectiveness of drugs or when a clinical trial has proven an expanded use of a drug to be effective, but it is still going through the final stages of FDA approval.

Here's some information about a study Mayo Clinic did about off-label use
- Off-Label Drug Use Common, but Patients May not Know They’re Taking Them, Mayo Finds https://newsnetwork.mayoclinic.org/discussion/off-label-drug-use-common-but-patients-may-not-know-theyre-taking-them-mayo-finds/

@rockey99, I recommend discussing with your doctor whether Pluvicto is an option appropriate for you and when.

I can only address this from me specifically, but I had to have chemo first and I’ve not talked to any other Patient that is getting it now that didn’t have to have chemo first. I would say the big issue with giving Pluvicto first would be Insurances not wanting to pay for it.

When I’ve heard this topic brought up in the various online and in-person support groups that I attend, I’ve never heard anyone say that they got access to Pluvicto without any chemotherapy.
I’ve heard them say that they weren’t on chemotherapy long (i.e., they didn’t wait for it to fail, and suffer all the adverse side-effects during that time).
Since they knew they were PSMA-positive, they were only on chemo briefly - technically, having “undergone chemo” - and then moved immediately to Pluvicto (with successful outcomes).
It’s all in the interpretation of the phrase “having undergone chemo.”

Yes. Although I completed chemo the guidelines don’t require completion. If you attempt it and it isn’t working or the side effects/lab work prevents you from finishing it you become a candidate for Pluvicto.

I am receiving the pluvicto treatment without having had chemotherapy.

My oncologist has basically done everything else and all other treatments have run their course and are no longer effective.

I lobbied him for several months to give me pluvicto. I specifically declined chemotherapy as it made no sense to me to kill off the good with the bad and hope that the good came back faster than the bad

He was prevented from doing this by the FDA guidelines which strictly adhered to the earlier clinical trial procedures of requiring chemotherapy first. That requirement was compounded by a manufacturing bottleneck which resulted in there not being enough Pluvecto to satisfy the demand even for those who already had chemotherapy.

The manufacturer solved the supply problem and at the same time began to loosen the real need for chemotherapy as a requirement to undergo this treatment. I went through the scans that showed my prostate cancer was indeed of the psma positive variety and that, plus the internal papers from the manufacturer was enough to get the treatment approved by my insurance.

I just had my second session. The first session went well, with a week of isolation. Side effects were constipation, even more fatigue and lack of energy, and boredom. After that my pain levels decreased noticeably and the increased fatigue went away. I think I am the very first patient of this oncologist to undergo the Pluvecto treatment without having had chemotherapy and I would rate it a success.

I glad you did what you wanted to do for your treatment.
I do have a question
I will be starting this treatment soon, my question is- you had a week of isolation, the Dr and what I've read is they say 3 to 4 days

Official guidelines is 3-4 days. We got our own Geiger counter so we could monitor the progress of the half life deterioration. They are only about $100 on Amazon. Out of an abundance of caution and not wanting to inflict "collateral damage" on anyone, and based on the radiation readings, my personal protocol is to isolate for one week, then be cautious about any prolonged contact for a second week. After that, no problem resuming "normal" prostate cancer life.

Thank you
Great answer and thinking

You're welcome. Hope it was beneficial to you.

Had a question for you. My first post. My dad had his first pluvicto over two weeks ago on jan 29 (day 0). We also bought a nice geiger counter on amazon from someones rec in this group. I also bought a lead apron as I transport my dad in a wheelchair to treatments and am closer than 3 feet from him. Just measured him today (day 15), and still getting readings when i place the geiger counter on his body around 2200 CPM. Some areas on his body are less. Did your levels ever come down after a week to the safe zone? Ours said around less than 50 is normal. If we sit 3 feet away, we are at a normal range.