Fred Saad, MD, FRCS, discusses clinical impact of darolutamide approval in mCSPC

On June 3, 2025, the FDA approved darolutamide (Nubeqa) for the treatment of patients with metastatic castration-sensitive prostate cancer (mCSPC).¹ Darolutamide was previously approved in the US for mCSPC in combination with docetaxel.

In a recent interview with Urology Times®, Fred Saad, MD, FRCS, discusses the implications of this expanded approval for clinical practice.

He noted, “Having as many options as possible is critically important for both us that are treating these patients, but also for patients, getting them involved in the decision making [and] addressing the realities of what other drugs they're taking.”

Saad is a professor and chairman of the department of surgery as well as the head of GU oncology at the University of Montreal.

According to Saad, the approval of darolutamide offers physicians another opportunity to personalize care in men with mCSPC. With all of these options, he argues that androgen-deprivation therapy (ADT) alone is no longer a sufficient treatment approach in these patients.

He explained, “I think the big take-home message is now we've got multiple, multiple drugs showing that we can do significantly better than ADT alone. ADT alone should basically be banned from the vocabulary in men with metastatic hormone-sensitive disease, because we can do so much better in all aspects, and we have drugs that are very well tolerated. Now we have the option of using a drug like darolutamide with or without docetaxel, another great opportunity in personalizing how we treat prostate cancer in men that present with this lethal form of prostate cancer, which is metastatic hormone-sensitive disease that has to be taken seriously.”