Darolutamide Monotherapy in ARAMON Trial: 52-Week Results in Non-Metastatic or Oligometastatic CSPC

A new study called ARAMON shows promising results for using darolutamide alone to treat non-metastatic or oligometastatic castration-sensitive prostate cancer (CSPC), as known as androgen pathway modulator sensitive (APMS), in men who have biochemical recurrence after surgery or radiation. This phase 2 trial enrolled 23 evaluable patients with PSA ≥0.2 ng/mL post-prostatectomy or ≥2 ng/mL post-radiotherapy, PSA doubling time ≤20 months, fewer than 5 asymptomatic metastatic lesions, testosterone >150 ng/dL, and good performance status. Patients received darolutamide 600 mg twice daily for 52 weeks without androgen deprivation therapy (ADT), the usual treatment that sharply lowers testosterone.

At baseline, the median age was 74 years (range 54–84), median PSA was 6.0 ng/mL (range 2.1–27.4), most had nonmetastatic disease (15/23), five had oligometastatic bone lesions, and three had small soft tissue metastases.
Darolutamide raised mean testosterone levels by 53% (95% CI 33–76%) after 12 weeks and 48% at 52 weeks, a milder increase than enzalutamide monotherapy (114% at week 25) or apalutamide (134%). It still delivered strong PSA control: 65% (15/23) reached PSA <0.2 ng/mL at 52 weeks and deep responses in 15 patients at week 12.

Side effects were mostly mild (grade 1/2), with only one patient quit due to gynecomastia after week 12, far better than ADT’s common issues like hot flashes, bone loss, and fatigue that hurt daily life.

Unlike ADT, which suppresses testosterone to <50 ng/dL, darolutamide monotherapy keeps hormone levels higher for potentially better quality of life while delaying cancer growth. The trial’s randomized phase will directly compare it to enzalutamide monotherapy on testosterone and PSA.

Shared at ASCO GU 2026, these results suggest darolutamide alone as a tolerable early option for CSPC biochemical recurrence, though the small, single-arm design calls for bigger confirmatory studies.

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