Darolutamide (Nubeqa) caused significantly less cognitive decline than enzalutamide (Xtandi) over 24 weeks in men with advanced prostate cancer, according to results from the phase 2 ARACOG trial, which are scheduled to be presented at the 2026 ASCO Annual Meeting. The findings represent the first randomized, prospective head-to-head comparison of the cognitive effects of two […]
The ARASEC trial, offers compelling evidence for darolutamide combined with androgen deprivation therapy as a treatment option for men with metastatic hormone-sensitive prostate cancer. This Phase 2 study tackled a challenging ethical dilemma in modern clinical trial design: how to evaluate a new treatment when randomizing patients to receive only standard ADT would be considered […]
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 […]
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 […]
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). […]
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 […]
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 […]
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