Dr. Stratton on phase 1B trial of relugolix and enzalutamide in high-risk prostate cancer

In this video, Kelly L. Stratton, MD, FACS, gives an overview of a phase 1B trial evaluating relugolix (Orgovyx) and enzalutamide (Xtandi) for high-risk prostate cancer. Stratton is an associate professor of urologic oncology at the University of Oklahoma, Oklahoma City.

Transcription:

Please provide an overview of this study.

This is a study of relugolix and enzalutamide in patients with locally advanced prostate cancer. These are high-risk patients who have high-grade cancer. Some of them may have pelvic lymph node disease, and we're looking at combined hormonal therapy, before radiation or surgery, and then also additional treatment after, again, either radiation or surgery. The rationale is that these patients are at very high risk for recurrence and the development of metastatic disease. We understand the activity of combined hormonal therapy, and our hope is that by adding combined hormonal therapy, both before and after local treatment, we can improve our outcomes for these patients. Unique to this study is that we'll be using Orgovyx, which is an oral drug that is a testosterone-reducing drug, an LHRH antagonist. That medicine works to lower the testosterone and different than what we typically use—leuprolide—it may have some potential benefits from the perspective that it may have less cardiac risks, it also works faster, and when you're done taking it, it stops working faster as well, so it doesn't linger as long as leuprolide would. Patients will receive 2 years of combined hormonal therapy in this study, and we'll be looking at the pathologic complete response rate in patients undergoing surgery, minimal disease rate in patients undergoing surgery, and then also objective response rate and patients either undergoing surgery or radiation.

This transcription was edited for clarity.