FDA protocol for PCa: In my last... - Advanced Prostate...

Advanced Prostate Cancer

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FDA protocol for PCa

dhccpa profile image
8 Replies

In my last appointment with MO on 12/12, we discussed a variety of developments over the last few years, including the PATCH trial, low dose estrogen, BAT, and other things.

My MO kept reverting to what the FDA has approved. I know they approve drugs and devices and procedures, but they weigh in more specifically for PCa treatment. I know they do things that affect sequencing of treatment, like saying that one must have chemo before Pluvicto, and that Darolutamide is for now for non-metastatic patients, but is that driven by the drug companies wanting things approved. For instance, if a wealthy person wants to pay for Daro out of sequence, regardless of insurance coverage, is there any prohibition on an MO prescribing it?

Same with estrogen or BAT, has the FDA weighed in in a prohibitive way?

Thanks for your input. I did point out to my MO that when I had brought up an FDA-approved treatment (Provenge, approved in 2009-10), he was of no help, leaving me treading water until I finally found a urologist to provide.

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dhccpa
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KocoPr profile image
KocoPr

I asked ChatGPT

Can a doctor legally prescribe fda approved drugs or procedures that is not standard of Care? For example i was prescribed darolutamide while still hormone sensitive and metatastic

note that i have asked ChatGPT to memorize my cancer history and notice it utilized my history in its answer.

Answer;

Yes, a doctor can legally prescribe FDA-approved drugs for indications that are not the officially approved or standard-of-care use. This is known as off-label prescribing, and it is both legal and common in oncology, especially for complex or advanced cases like metastatic prostate cancer.

Key Considerations for Off-Label Prescribing:

1. Clinical Judgment & Evidence – Physicians may prescribe off-label if they believe it offers potential benefit based on scientific evidence, case studies, or clinical experience.

2. Informed Consent – Doctors should discuss the rationale, potential benefits, risks, and uncertainties with the patient.

3. Insurance Coverage – Some off-label uses may not be covered by insurance unless there is strong supporting evidence or inclusion in guidelines like the NCCN (National Comprehensive Cancer Network).

4. Regulatory & Ethical Considerations – The FDA regulates drug approval but does not control how doctors prescribe medications once they are on the market.

Your Case:

• Darolutamide (Nubeqa) is FDA-approved for non-metastatic castration-resistant prostate cancer (nmCRPC) and metastatic castration-sensitive prostate cancer (mCSPC) in combination with docetaxel.

• However, your doctor prescribed darolutamide off-label for hormone-sensitive metastatic prostate cancer (without docetaxel)—which is not standard of care but is reasonable based on emerging clinical data and your individual case.

• Given your MSH6-loss and RAD50 mutation, your case is not typical, and your doctor may have chosen this approach based on a personalized strategy.

Off-label prescribing is a well-accepted practice in oncology, where treatment decisions often depend on evolving research and a patient’s specific tumor biology. It sounds like your doctor tailored your treatment with that in mind.

dhccpa profile image
dhccpa in reply toKocoPr

Excellent, thanks. I use AI but need to do it more.

KocoPr profile image
KocoPr in reply todhccpa

It’s essential

KocoPr profile image
KocoPr in reply toKocoPr

I use “notion.so” to organize my medical history and sync it to both desktop and iPhone then i also paste the whole thing into my cancer story which is one of the docs i created on my ChatGPT. From there i can call up anything in my history and i can also do so much more like search clinical trials best suited for my mutations or present conditions and sooo much more. I pay the 20bucks a month and it is the best investment i have made for my health

DesertDaisy profile image
DesertDaisy

Agree 100%. It's maddening.

NanoMRI profile image
NanoMRI

I seem to commonly go against guidelines, sometimes insurance covered, sometimes not. As explained to me , Guidelines themselves are not laws with criminal penalties. Docs are covered by the very broad spectrum of what is often said to be SOC.

I have a solid understanding that docs are often steered by their training/experiences, or not, by the purchase/volume contracts their medical group has, by time limitations on thru put, coding and ease of billing/collections.

AlmostnoHope profile image
AlmostnoHope in reply toNanoMRI

You are so correct. That's why there are so many scarecrows on here. There are better ways.

dhccpa profile image
dhccpa in reply toNanoMRI

I've heard that from two nurses I know who aren't part of my own care.

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