Findings in the Docetaxel-Naive Patient Population

Summary for Physicians: Findings in DOC-Naive Population and Clinical Implications

In the docetaxel (DOC)-naive population:

• Treatment benefit appears consistent with the overall study population across both enzalutamide and darolutamide trials.
• Radiographic progression-free survival improvements remain significant compared with ADT alone.
• No clear efficacy differences between the agents have been definitively established in this specific subgroup.
• Treatment sequencing decisions (androgen receptor [AR] pathway inhibitor first vs docetaxel first) remain an area of clinical judgment.

Clinical implications:

• DOC-naive patients represent an important subgroup that may derive substantial benefit from AR pathway inhibitors.
• Treatment selection should consider disease burden, patient fitness for chemotherapy, comorbidities, and patient preference.
• For patients unlikely to tolerate docetaxel, either enzalutamide or darolutamide plus androgen deprivation therapy provides a valuable treatment option.
• Monitoring for long-term outcomes in this subpopulation remains important as data mature.

These findings support the role of AR pathway inhibitors as effective first-line options in DOC-naive patients with mHSPC.