Hi, I'm Dr. Scholz. Let's talk about clinical trials for prostate cancer.
Men who are considering a radical prostatectomy who are in the Azure category, that's the
high-risk category (PSA over 20, Gleason score 8, 9, 10, or perhaps a large tumor in the
prostate itself), could consider taking a combination of surgery plus hormone therapy.
This is a really interesting question. Historically, hormone therapy has been reserved only for
men who are getting radiation, but long-term cure rates with high-risk prostate cancer
(with Azure) using surgery have not been very good. And there are some studies. Tanya Dorff
published a study in the "Journal of Clinical Oncology" about five years ago that showed
about 90% disease-free survival rates when men with high-risk disease got Lupron for
about a year. Lupron is another name for LHRH agonists. There's a bunch of medicines to
such a Firmagon and Trelstar. But 12 months of such hormone therapy was effective in that study
So, Janssen Pharmaceuticals is funding a trial in 1500 men who have high-risk prostate cancer.
Half of the men are going to get a Lupron type drug in addition to the surgery. The
other half are going to get Lupron plus apalutamide (or "Erleada"). Apalutamide is a recently
approved medicine for advanced prostate cancer. It has a unique mode of hormonal blockade.
It blocks the androgen receptor inside the cancer cell and thus is more effective than
traditional blockade such as Lupron. It's a pill; four pills are taken once a day. It's
well-tolerated. It can induce all of the similar problems that we see with low testosterone.
There's also an incidence of some skin rashes, but the effectiveness is definitely proven
and the overall tolerability is acceptable. So, the study's got an interesting design.
The men are going to get six months of hormone treatment before the surgery. At the time
of surgery, when the prostate is removed, they're going to be able to look and see how
much shrinkage there was in the original tumor. In some cases, previous studies have shown
that the tumors can disappear altogether. The hormone treatment, then, will be continued
for an additional six months, for a total of 12 months, then it will be stopped, testosterone
will recover, and comparisons will be made between the two groups. The group that got
just 12 months of Lupron and the group that got 12 months of Lupron plus apalutamide.
Hopefully, they'll show improved cure rates and if that's the case, then the men who got
apalutamide will be leading the way towards a new way to treat prostate cancer going forward,
at least in the men who decide to do surgery. So if this study is successful and does indeed
show higher cure rates over time (cure rates as judged by less metastasis, less PSA relapses)
then this type of treatment in all likelihood will become a standard approach for men with
high-risk disease who are undergoing radical prostatectomy.
So, if you want to participate in this clinical trial, instructions are on the screen. There
are multiple centers throughout the country and the opportunity to participate should
be easily accessible.