Prostate Cancer Clinical Trials Consortium (PCCTC)

Prostate Cancer Clinical Trials Consortium:
Bringing the “Best of the Best” to Prostate Cancer Patients Beer: There is no other organization in the
country that has accelerated research in one disease as—as much as the Prostate Cancer
Clinical Trials Consortium has. It has shown us how to get institutions that are large,
ambitious, and generally have worked on their own in the past—how to get them working
together and not just working together but being passionate about working together. That’s
what the PCRP has done. The PCRP is truly unique in accelerating moving
drugs from the laboratory into patients and making a difference. And we’re seeing now
in this last year, we had two drugs approved for advanced prostate cancer that improved
survival. We’ve gone from one to three drugs that can improve survival. We have another
one before the FDA that the consortium was heavily involved in that many of us expect
will get approved, and more drugs in Phase 3 studies than ever before, so we’ve gone
from a disease that was virtually untreatable to having multiple treatment options that
can extend the life of patients with advanced prostate cancer. And we’re seeing that kind
of progress just in the last couple of years. Higano: One of the projects that shows what
we contribute as a member of the consortium relates to the development of an agent called
IMCA12, which is an IGF-1 receptor inhibitor. Our scientists have done a lot of preclinical
work with this agent and we actually did the so-called first in human Phase 1 trial where
we gave the antibody for the very first time. So our institution did that within the consortium;
we did the Phase 2 study of this agent in a very specific population of prostate cancer
patients. We then went on in conjunction with the University of Michigan, Maha Hussain’s
group, and spearheaded a trial looking at this agent in combination with a chemotherapy
drug. And now again going back to that science that came out of our institution, we’re
doing a trial in a cooperative group, the Southwest Oncology Group looking at hormonal
therapy with or without this IMCA12 or cixutumumab drug. So I think you know that kind of shows
how you as a member of the consortium can take something that’s early in the drug
development, bring it through to a late-stage treatment, and design trials actually based
on the science at your own place. Scher: The amount of work that it takes to
bring a trial to fruition is enormous. The beauty of this group is not only does it streamline
the process, but with the underpinning of the scientists you’re starting to think
about the questions you will need to answer 3 or 4 years hence. And as everything is running
in parallel, they’ve already done the work so my trial can be written now. And that’s
in fact exactly what’s happening. A total of 133 concepts have been submitted
for review in a little bit over a 5-year period. We’ve approved 106; we’ve activated 84;
we’ve actually completed 48 studies. I’m thinking now as somebody who is getting older,
I want to work on things that will go all the way through. When the sponsors align and
each group does what they do best, the trials can go like wildfire. Heath: Detroit is a predominantly high African
American population so as we have heard at multiple meetings, there is a health disparity
that I see every day in my patients. Having the opportunity to take newer drugs, the best
of the best if you will, to our patients in Detroit who are already at high-risk, have
higher morbidity, higher mortality—that is an opportunity that’s unparalleled. The number one thing I get asked is—what
happens if this fails? Patients want to know that you have a plan from A to Z. And that’s
a critical part, and being part of the consortium allows that because we have trials everywhere.
And so when patients get a sense of that road map, they feel much more confident about their
own disease and can empower themselves in figuring out where they want to go. And I
think that’s a critical part for their overall well-being. Scher: So the beauty of the program is not
only its diversity but how it focuses on critical questions—ones that are not typically asked
by funding agencies, but are really relevant to the end-game which is how do we help patients. Higano: Everybody has their own personalities
and their work styles. But at the end of the day despite its challenges, I think we’ve
all been very gratified being part of the consortium because of the product at the end
of the day. Heath: We get to sit with 12 other major centers
dedicated to prostate cancer research and share our ideas for translation of new drugs,
new concepts and also to participate in the most cutting-edge clinical trials—terrific
opportunity. Beer: This is certainly not the only answer
to the prostate cancer problem. There are many, many approaches but I think the theme
is one of really drilling down to better understand what the right therapeutic targets are and
in the next generation individualizing that potentially to each individual patient by
studying their own cancer—that’s where I think the future is taking us and that’s
the kind of work that we’re seeing really across the centers supported by the PCRP. Scher: Typically when I talk to my friends
and say you know one of our major supporters is the Department of Defense and get a reaction
like why is that. And when you start to explain it and the scope of the program they go wow. When you look at the range of topics that
are conducted from biological warfare to tuberous sclerosis to various cancers, I obviously
don’t have direct knowledge of those other programs but if they’re anything like what’s
going on in the prostate cancer field it’s staggering.

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