Video: Darolutamide (Nubeqa) + Lupron 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.

Clinical trials are the cutting-edge of new discoveries and the PCRI has asked me to pick out some of the salient trials that are leading the way towards new discoveries and better treatment. 

In this particular clinical trial, I'd like to cover an 1100 patient series that's presently underway looking at whether or not adding darolutamide to Lupron can help men who are in High-Azure or in the Indigo stage. These are men who have high-risk prostate cancer with unfavorable features. Men that have Gleason 9 and 10, PSAs over 20, large bumps when you do a digital rectal, seminal vesicle invasion, lymph nodes in the pelvis. They're even accepting men that have had previous surgery in whom the PSA never dropped down to zero or in men that had recent surgery and they found lymph nodes at the time of surgery. These are all descriptions of a high-risk more dangerous type of prostate cancer and it's very logical to consider adding a more potent hormonal agent. 

It's well known that adding Lupron in this situation is helpful in delaying the onset of metastasis, and that's what they're going to be looking at in this 1100 patient trial. They're going to divide the men between Lupron alone for about 22 months versus Lupron plus darolutamide for 22 months, and the expectation—our hope for the trial—is that the men who get the darolutamide will have a better outcome. It wouldn't be surprising. I mean, it is a more potent agent and it has been already FDA approved in more advanced stages of prostate cancer and shown to be effective. Darolutamide, otherwise known as Nubeqa, is a pill that's taken twice a day. Compared to Lupron, it probably doesn't have a whole lot of additional side effects in most people. Maybe in some men, there will be a little bit more fatigue, but it is quite well tolerated. This is an opportunity for patients because this medicine is very expensive. I'm not quite sure the precise cost, but somewhere in the range of $10,000 a month. I mean, we're really pricey with this agent. So, to be able to get it on a clinical trial which would be free of charge to the patients is a real opportunity. 

So this trial is going to require a few years before we know the outcome, but if it does demonstrate that men have a delay in the onset of metastasis and better survival with darolutamide, this trial could make giving this agent—or second-generation hormonal agents like it—the standard of care for men with Azure—High-Azure and Indigo stage prostate cancer. 

If you want more information about how to participate in this trial, we'll provide those on the screen to follow.