The phase 3 DASL-HiCaP trial, presented at ESMO 2026, has demonstrated improved metastasis-free survival with the addition of darolutamide to androgen deprivation therapy (ADT) and radiotherapy in patients with localised or locally advanced prostate cancer at high risk of recurrence. The randomised, placebo-controlled study enrolled 1,106 patients, who received darolutamide or placebo alongside ADT and […]
Updated results from the phase 1/2 CELC-G-201 trial (we talked about it in this previous article) provide new evidence of antitumor activity for gedatolisib combined with darolutamide in patients with metastatic castration-resistant prostate cancer (mCRPC) previously treated with androgen receptor pathway inhibitors (ARPIs). Gedatolisib inhibits the PI3K–AKT–mTOR signaling pathway, which can contribute to resistance to […]
A newly registered randomised phase 2/3trial will test an unusual strategy in metastatic androgen pathway modulation-resistant prostate cancer (mAPMR; formerly mCRPC or castration-resistant prostate cancer): deliberately exposing resistant cancer cells to very high testosterone levels before attacking the androgen receptor again with darolutamide. The study plans to enrol 432 patients with mCRPC who have already […]
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 […]
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