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Standard ADT (androgen deprivation therapy)

DRUG2 trials

Sponsors

Bayer, Jena University Hospital

Conditions

Metastatic Hormone-Sensitive Prostate Cancer (mHSPC)Metastatic Hormone-sensitive Prostate Cancer

Phase 3

Darolutamide in Addition to Standard Androgen Deprivation Therapy and Docetaxel in Metastatic Hormone-Sensitive Prostate Cancer
CompletedNCT02799602
BayerMetastatic Hormone-sensitive Prostate Cancer
Start: 2016-11-30End: 2023-04-11Updated: 2025-12-04
A Trial Comparing Docetaxel 75 mg/m2 (3w) Versus Docetaxel 50 mg/m2 (2w) in Combination With Darolutamide + ADT in mHSPC Patients
Active, not recruitingNCT05676203
Jena University HospitalMetastatic Hormone-Sensitive Prostate Cancer (mHSPC)
Start: 2023-05-16End: 2026-12-01Updated: 2026-08-05

Related Papers

Postprogression Survival of Patients with Metastatic Hormone-sensitive Prostate Cancer who Received Darolutamide or Placebo in Combination with Docetaxel and Androgen Deprivation Therapy: Post Hoc Analysis of the Phase 3 ARASENS Trial.
2025-06-201 citations
Age-related efficacy and safety of darolutamide plus androgen-deprivation therapy (ADT) and docetaxel in patients with metastatic hormone-sensitive prostate cancer (mHSPC): A subgroup analysis of ARASENS.
Journal of Clinical Oncology2025-02-103 citations
Concomitant G-CSF use in maintaining an efficacious dose and safe delivery of docetaxel in combination with darolutamide in patients with metastatic hormone sensitive prostate cancer (mHSPC): ARASENS, a phase 3 study.
Journal of Clinical Oncology2025-02-101 citations
Darolutamide in Japanese patients with metastatic hormone‐sensitive prostate cancer: Phase 3 <scp>ARASENS</scp> subgroup analysis
Cancer Medicine2024-11-014 citations
Post-progression survival of patients with metastatic hormone-sensitive prostate cancer (mHSPC) who received darolutamide or placebo: Post hoc analysis of ARASENS.
Journal of Clinical Oncology2024-06-01
Deep and Durable Prostate-specific Antigen Response to Darolutamide with Androgen Deprivation Therapy and Docetaxel, and Association with Clinical Outcomes for Patients with High- or Low-volume Metastatic Hormone-sensitive Prostate Cancer: Analyses of the Randomized Phase 3 ARASENS Study.
2024-04-2129 citations
Overall survival with darolutamide vs placebo in combination with androgen-deprivation therapy (ADT) and docetaxel: A sensitivity analysis from ARASENS accounting for subsequent therapy.
Journal of Clinical Oncology2024-01-293 citations
ARAMON: A phase 2, randomized, open-label study comparing darolutamide (DARO) vs enzalutamide (ENZA) monotherapy on serum testosterone levels in patients (pts) with castration-sensitive prostate cancer (CSPC) after biochemical recurrence (BCR).
Journal of Clinical Oncology2024-01-291 citations
Efficacy and Safety of Darolutamide in Combination With Androgen-Deprivation Therapy and Docetaxel in Black Patients From the Randomized ARASENS Trial
The Oncologist2023-10-093 citations
Efficacy and safety of darolutamide in Chinese patients with metastatic hormone-sensitive prostate cancer (mHSPC): A subpopulation analysis of the phase 3 ARASENS study.
Journal of Clinical Oncology2023-06-011 citations
Darolutamide and time to pain progression by disease volume in ARASENS.
Journal of Clinical Oncology2023-06-01
Open-label study of darolutamide plus androgen-deprivation therapy (ADT) vs ADT in metastatic hormone-sensitive prostate cancer using an external control arm (ARASEC).
Journal of Clinical Oncology2023-06-01
MP29-01 RAPID, DURABLE, AND DEEP PROSTATE-SPECIFIC ANTIGEN RESPONSE FOLLOWING ADDITION OF DAROLUTAMIDE TO ANDROGEN-DEPRIVATION THERAPY AND DOCETAXEL IN ARASENS
The Journal of Urology2023-03-233 citations
MP29-02 EFFICACY AND SAFETY OF DAROLUTAMIDE IN COMBINATION WITH ANDROGEN-DEPRIVATION THERAPY AND DOCETAXEL IN THE NORTH AMERICAN POPULATION FROM ARASENS
The Journal of Urology2023-03-231 citations
Efficacy and safety of darolutamide (DARO) in combination with androgen-deprivation therapy (ADT) and docetaxel (DOC) by disease volume and disease risk in the phase 3 ARASENS study.
Journal of Clinical Oncology2023-02-209 citations
Dosing, safety, and pharmacokinetics (PK) of combination therapy with darolutamide (DARO), androgen-deprivation therapy (ADT), and docetaxel (DOC) in patients with metastatic hormone-sensitive prostate cancer (mHSPC) in the ARASENS study.
Journal of Clinical Oncology2023-02-206 citations
Darolutamide plus androgen-deprivation therapy (ADT) versus ADT in metastatic hormone-sensitive prostate cancer: Open-label single-arm study with an external control arm (ARASEC).
Journal of Clinical Oncology2023-02-202 citations
Abstract B131: Efficacy and safety of darolutamide in combination with androgen-deprivation therapy (ADT) and docetaxel in Black/African-American patients from the phase 3 ARASENS trial
Cancer Epidemiology Biomarkers & Prevention2023-01-011 citations
Darolutamide and survival in metastatic, hormone-sensitive prostate cancer: a patient and caregiver perspective and plain language summary of the ARASENS trial.
2022-06-039 citations
Association of prostate-specific antigen (PSA) response and overall survival (OS) in patients with metastatic hormone-sensitive prostate cancer (mHSPC) from the phase 3 ARASENS trial.
Journal of Clinical Oncology2022-06-0123 citations

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