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A recent phase III randomized controlled trial (RCT: ARASENS) demonstrated significant improvement in overall survival (OS) for men with metastatic hormone-sensitive prostate cancer (mHSPC) who received triplet therapy (androgen deprivation therapy [ADT] plus docetaxel plus darolutamide; an androgen signaling inhibitor [ASI], as compared with ADT plus docetaxel).

The PEACE-1 trial reported improved OS for ADT plus abiraterone, an androgen synthesis inhibitor (also designated ASI), compared with ADT alone; the protocol was amended to recommend docetaxel in both experimental and control arms, and approximately 60% of men in both arms received it.

The ARASENS trial also showed improvement in other clinically meaningful outcomes linked to quality of life (e.g., time to next skeletal-related event, time to pain progression) with an acceptable safety profile.

With these results from two large phase III RCTs, triplet therapy will be regarded by many as the new standard of care for men with mHSPC. However, is triple therapy (ADT plus an ASI plus docetaxel) better than ADT plus an ASI?

Triplet therapy may be a viable option for men with mHSPC who would otherwise have been offered ADT plus docetaxel. The benefits of triplet therapy over ADT plus an ASI remain questionable, because of the lack of head-to-head comparisons.

In the absence of definitive evidence of benefit, particularly in men with lower-grade, low-volume mHSPC, the default should be to simpler, less toxic treatment.

Read an interview about the study here and expert commentary about it here.