So, Dr. Scholz, today we're talking about what they call the M0 space, and I know that this has
come up in many of our helpline calls and talking to patients, and there's new treatments that have
come in that can really help in this space, but first of all can we talk about what M0 is?
M0 is sort of an artificial construct that was created for some clinical trials to
get FDA approval for some very powerful second-generation hormone medicines such as
Xtandi, Zytiga, Nubeqa, and Erleada. By defining this space—which is men that have been on Lupron
and now have developed a rising PSA, and when they get scans they don't see any spots of cancer
outside the pelvis. They see no spots in the bones, no spots in the lungs, no spots in the
lymph nodes above the pelvis, and so "M" stands for metastases, so M0 means "no metastases,"
but in someone who has developed a rising PSA while on Lupron.
Oftentimes, I've heard patients kind of get confused and I've understood that even
when I speak to doctors this doesn't seem to be clear, you know, they talk about localized
prostate cancer being within the prostate, and then we talk about metastases, and normally
people think anything outside the prostate, so can you explain why you would consider
metastases that are in the lymph nodes below the pelvis non-metastatic versus metastatic.
Well, technically they are metastatic even if you have lymph nodes in the pelvis region which is
right around the prostate, but this idea that some of these people can be still cured with treatment
even though they have early lymph node disease I think is why there's a separation.
There's the same type of separation in breast cancer where women have early spread from their
breasts to the lymph nodes under in the armpit and some of those women are still curable even though
there's some early spread, so the implications of metastasis generally, as you've pointed out,
is the idea that you're not curable, but the idea of making a distinction between M0 and allowing
some early metastasis to the lymph nodes of the pelvis—or in breast cancer to the to the armpit—is
making a distinction between who we're going to try and cure and who are just going to try
and control the disease, so I think that's why there's a trade-off and it is confusing
because there are early metastasis in some of these M0 patients although it's confined
only to lymph nodes and only to the pelvis. If there's pelvic bone metastasis that's not M0.
With imaging, obviously these people are not getting PSMA scans; what is a normal protocol for
imaging that they're getting where they, you know, would be checking to see where these spots are?
Well, historically people would get a cat scan, an MRI, or a bone scan,
and, of course, we've known through the years that that's a fairly crude measure and that
may be partly why you have this idea of no metastasis because as better scans came out
you're talking about the PSMA PET scan which was recently FDA approved, we're starting to see that
some of these M0 patients where they didn't even see lymph nodes in the pelvis actually do have
some early metastatic disease, we just couldn't detect it with the old cat scans, bone scans,
and MRIs. Now we've reached a watershed time in the prostate cancer management realm because
with PSMA PET scans we're going to see a lot more metastasis. These scans are so much more
accurate and sensitive and that will probably supersede all the other scans; we probably won't
be doing bone scans anymore; we probably won't be doing cat scans looking for lymph nodes anymore.
So, these treatments that have been approved for the M0 space, what happens to them and how
will patients be affected in getting them with this new advent of PSMA coming out?
Well , you know, this is an insurance construct; these are very expensive medicines and so when
a new medicine is approved for a segment of a of a disease the insurance companies
stand firmly on the premise that you can't use it for anything outside this segment because it's so
expensive—they want to save money. Fortunately, the clinical trials that were done looking at the
second generation hormonal medicines like Zytiga, Xtandi, Nubeqa, and Erleada all allowed for some
early metastasis in the pelvic area with lymph nodes, and so that pretty much leaves the door
open for using these medicines in the traditional M0 space even when there are some pelvic lymph
nodes detected. Because the clinical trials were designed to include those folks, the insurance
companies don't really have a leg to stand on when they say they're not going to pay for it,
and for that reason, they typically will pay for these rather pricey drugs.
Hi everyone this is me and Hunter. No, we did not name him Prostate or Gleason,
but thank you so much for your comment recommendations.
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