"Darolutamide achieved the primary endpoint. Easily 100% of the patients had a PSA decrease above 90%," says Bertrand F. Tombal, MD, PhD.
In this video, Bertrand F. Tombal, MD, PhD, discusses a phase 2 study of darolutamide as a monotherapy vs. androgren deprivation therapy (ADT) for men with hormone-naïve prostate cancer. The findings were presented at the 2023 ASCO Genitourinary Cancers Symposium in San Francisco, California. Tombal is a urologist at Cliniques Universitaires Saint Luc in Brussels, Belgium.
Could you describe the background for this study?
Darolutamide is one of the AR pathway inhibitors that we commonly use in prostate cancer now, together with enzalutamide, and apalutamide. Usually, these drugs are used on top of androgen deprivation therapy, either in patients with metastatic hormone-sensitive prostate cancer or with non-metastatic CRPC. But historically, first generation of this class such as bicalutamide, flutamide, we also use them in monotherapy to avoid the [adverse events] of castration. Here, what we wanted to do is to test whether we could use darolutamide as a single agent, and not in combination with androgen deprivation therapy, and to compare this in a small phase 2 where the patients were randomized between darolutamide alone or any of the androgen deprivation therapy agents people use usually.
What were some of the notable findings?
In that study, what we looked at was very simple, is whether it decreases PSA. We took as an objective to decrease PSA by more than 80% and more than 90%. Actually darolutamide achieved the primary endpoint. Easily 100% of the patients had a PSA decrease above 90%. Although we don't want to make comparisons, the group of androgen deprivation therapy was there for reference. It's at least, by the number, a little bit superior to the androgen deprivation therapy.
The second objective was to look at quality of life using a validated instrument such as EROTC questionnaire and the AMS scale. What we showed is that actually, darolutamide seems to have much less impact on quality of life, especially when it comes to hormonal [adverse events], and the impact on quality of life of hormonal [adverse events]. That's very promising. It seems that we can actually suppress PSA while avoiding the deterioration of quality of life usually seen with these agents.
This transcription has been edited for clarity.