Tag Archive for: darolutamide

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 […]

Darolutamide Linked to Better Real‑World Outcomes than Enzalutamide or Apalutamide in nmCRPC

A large real‑world study in nonmetastatic castration‑resistant prostate cancer (nmCRPC) called DEAR‑EXT, published on Nature, has added new detail to how the three androgen receptor inhibitors (darolutamide, enzalutamide, and apalutamide) behave outside of randomized trials, using data from over 1,300 men treated in US urology practices between 2019 and 2023. The analysis builds on an […]

Phase 1/2 Trial: Valemetostat Plus Darolutamide in mCRPC

A phase 1/2 clinical trial investigating valemetostat (DS-3201b), a dual EZH1/2 inhibitor, combined with darolutamide in metastatic castration-resistant prostate cancer (mCRPC) is going to start to recruit participants. This study aims to evaluate the safety, tolerability, and preliminary efficacy of the combination in men whose disease has progressed despite prior androgen receptor pathway inhibitors (ARPIs). […]

Phase 1/2 Trial to Evaluate Gedatolisib Plus Darolutamide Combo in mCRPC

Gedatolisib, an inhibitor targeting the PI3K/AKT/mTOR pathway, in combination with darolutamide, an androgen receptor antagonist, is being evaluated as a treatment option for metastatic castration-resistant prostate cancer (mCRPC). In a phase 1/2 clinical trial, patients who had progressed on prior androgen receptor signaling inhibitors received once-weekly intravenous gedatolisib in doses of 120 mg or 180 […]

ARASAFE Trial Offers Safer Docetaxel-Darolutamide-ADT Regimen for mHSPC

Recent data presented at the 2025 European Society for Medical Oncology (ESMO) Congress reveal a promising new treatment schedule for patients with metastatic hormone-sensitive prostate cancer (mHSPC). The phase 3 ARASAFE trial evaluated an alternative docetaxel dosing regimen combined with darolutamide and androgen deprivation therapy (ADT), showing significant reductions in severe toxicities while maintaining effective […]

Phase 2 Trial: Supraphysiologic Testosterone Priming Induces Darolutamide Extended Response via Modulation of Androgen Receptor (SPIDERMAN)