Video: Apalutamide for High-Risk Prostate Cancer | Learn About Clinical Trials

Learn About Clinical Trials | Transcription

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.