Himalayas‑1 is a newly initiated global Phase 3 registrational trial testing rinzimetostat (ORIC-944) in combination with darolutamide in men with metastatic castration‑resistant prostate cancer (mCRPC) who have previously been treated with abiraterone. The trial is designed as a pivotal study intended to support approval if the results are positive, with about 600 patients planned across […]
A new trial phase 1 trial is investigating the combination of 177Lu-PSMA-617 (Pluvicto) with darolutamide in high-risk localized prostate cancer. Both agents are already established in prostate cancer care, but using them together before surgery is a novel way to intensify treatment in patients whose disease is still potentially curable. Its main idea is simple: […]
Using data from the international ARON-3 real-world study, investigators performed a retrospective head-to-head comparison of darolutamide- and abiraterone-based triplet therapy in patients with metastatic hormone-sensitive prostate cancer. The comparison included 247 patients treated with darolutamide plus docetaxel plus androgen deprivation therapy or abiraterone plus docetaxel plus androgen deprivation therapy across 37 institutions in 14 countries. […]
Mevrometostat is an oral EZH2 inhibitor being developed to overcome resistance to androgen‑receptor–targeted therapy in prostate cancer. In tumors, EZH2 helps switch off tumor‑suppressor genes and supports androgen‑independent growth and lineage plasticity, changes that are strongly linked to progression on drugs like enzalutamide. Adding an EZH2 inhibitor to continued AR blockade is meant to “re‑discipline” […]
In the phase 3 CaBRA trial, carboplatin is added to the docetaxel-based chemotherapy backbone used with lifelong ADT (androgen deprivation therapy) and darolutamide, creating a quadruple-intensification therapy for a small but very high-risk subgroup of metastatic castration-sensitive prostate cancer. The trial focuses on tumors with either BRCA alterations or neuroendocrine differentiation, two features that are […]
A Phase 1b/2 trial is planned to test the investigational KAT6 inhibitor OP-3136 combined with darolutamide in metastatic castration-resistant prostate cancer (mCRPC). About 36 patients will be enrolled, with the study expected to start in the second half of 2026. The focus is on safety, tolerability, and early signs of anti-tumor activity. OP-3136 blocks KAT6A/B, […]
Agents such as abiraterone and darolutamide have demonstrated significant survival benefits in randomized clinical trials, yet direct comparative evidence between these therapies, particularly in the pre-chemotherapy setting, remains notably absent. A recent retrospective cohort analysis leveraging the TriNetX database attempts to address this gap by comparing real-world outcomes in patients treated with ADT plus either […]
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 […]
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