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The ARASENS Trial: Darolutamide and Survival in Metastatic, Hormone-Sensitive Prostate Cancer

Curated by Clinicians: Educational Forum with Videos, Abstracts and Conference Information
Videos
Q-TWIST Analysis Applied to ARASENS Trial in Metastatic Hormone-Sensitive Prostate Cancer - Brigida Maiorano
Quality of Life and Treatment Intensification in mHSPC - Fred Saad
Multidisciplinary Strategies for Managing the Complexities of mHSPC Care - Neal Shore
Association of PSA Trajectories with Survival in mHSPC from ARASENS and ARANOTE Trials - Christopher Wallis
Evolution of Chemohormonal Therapy for Metastatic Prostate Cancer - Pedro Barata
ARASENS Trial Analysis Investigates Impact of Initial PSA Values on Treatment Response in mHSPC - Alicia Morgans
2024 NCCN Prostate Cancer Guidelines: Updates in M1 CSPC Treatment - Rashid Sayyid & Zachary Klaassen
Darolutamide Outcomes in European Patients with Metastatic Hormone-Sensitive Prostate Cancer from the ARASENS Trial - Bertrand Tombal
Chinese Subgroup Analysis Reveals Both Similar and Distinct Responses to Novel Darolutamide Combination Therapy - Yao Zhu
ARASENS Phase 3 Clinical Trial Regimen Demonstrates Significant Survival Benefit for Chinese Patients - Yong YANG
Deep PSA Response Following Addition of Darolutamide to ADT and Docetaxel in ARASENS - Fred Saad
Exploring Darolutamide's Impact on Time to Pain Progression Based on Disease Volume in the ARASENS Study - Matthew Smith
Efficacy and Safety of Darolutamide in Combination with ADT and Docetaxel by Disease Volume and Disease Risk in the ARASENS Trial - Karim Fizazi
Phase 3 ARASENS Study, The Impact of Disease Burden and Risk on Efficacy and Safety Outcomes - Matthew Smith
Analyzing the ARASENS Trial: Darolutamide Boosts Survival in Prostate Cancer Subgroups Journal Club - Zachary Klaassen
Quality of Life and Patient-relevant Endpoints With Darolutamide in the ARASENS Trial - Karim Fizazi
The ARASENS Trial in Metastatic Hormone-Sensitive Prostate Cancer: Benefits In the Urologic Clinical Practice - Neal Shore
A Urologist's Perspective On Treatment with Darolutamide in the Metastatic Hormone Sensitive Patient - Neal Shore
Outcomes of the ARASENS Trial by Metastatic Subtype - Bertrand Tombal
Darolutamide Approved for Patients with mHSPC - Charles Ryan
The Association of PSA Response and Overall Survival in Patients with mHSPC in the Phase 3 ARASENS Trial - Fred Saad
No Longer ADT Alone in Metastatic Hormone-Sensitive Prostate Cancer, The ARASENS Trial - Cora Sternberg
Early Triplet Combination Therapy Shows Increased Overall Survival: The ARASENS Trial - Tomasz Beer
Treatment Considerations in Advanced Prostate Cancer - Bertrand Tombal
Practice Changing Data from ARASENS - Statistically Significant Overall Survival - Fred Saad, Bertrand Tombal, and Neal Shore
ARASENS: A Phase 3 Trial of Darolutamide in Combination with Docetaxel for Men with Metastatic Hormone-Sensitive Prostate Cancer (mHSPC). Journal Club - Christopher Wallis & Zachary Klaassen
ARASENS Trial Significantly Improves Overall Survival with Darolutamide in Combination with ADT and Docetaxel for Metastatic Hormone-Sensitive Prostate Cancer - Matthew Smith
Advanced Prostate Cancer Practice Informing Data Presented at ASCO GU 2022 - Oliver Sartor
Darolutamide and Survival in Metastatic Hormone-Sensitive Prostate Cancer - ARASENS Trial - Karim Fizazi

Continuum of Care for Patients with Metastatic Hormone-Sensitive Prostate Cancer

Conference Coverage
Conference Highlights Written by Physician Scientists
Presented by Shinro Hata, MD
The American Urological Association's 2026 Annual Meeting, between May 15 – May 18, 2026 in Washington D.C., was host to the Interactive Poster IP38: Prostate Cancer: Advanced I Session. Dr. Shinro Hata presented interactive poster IP38-14: Dissecting Synergistic vs. Additive Contributions to Survival in the ARASENS Triplet Regimen: A Modeling Analysis
(UroToday.com) The 2026 American Urological Association annual meeting featured practice-changing, paradigm-shifting clinical trials in urology and a presentation by Dr. Rana McKay discussing data from ARASEC, a US prospective, open-label, phase 2 study with an external control assessing darolutamide + ADT in metastatic hormone-sensitive prostate cancer (mHSPC).
Presented by Brigida Anna Maiorano, MD, PhD
The 2026 GU ASCO annual meeting featured a prostate cancer session and a presentation by Dr. Brigida Anna Maiorano discussing an analysis of quality-adjusted time without symptoms or toxicity (Q-TWIST) in patients with metastatic hormone-sensitive prostate cancer (mHSPC) from the ARASENS trial.
Presented by Yufan Y. Zhao
Dr. Yufan Y. Zhao presented a post hoc analysis of ARASENS evaluating the impact of lead-in androgen deprivation therapy (ADT) on severe neutropenia (grade≥3) secondary to docetaxel in metastatic hormone-sensitive prostate cancer (mHSPC) patients.
Presented by Alicia Morgans, MD, MPH
The 2025 EAU annual meeting featured a prostate cancer session and a presentation by Dr. Alicia Morgans discussing the impact of baseline PSA on clinical outcomes in patients with metastatic hormone sensitive prostate cancer (mHSPC) treated with darolutamide triplet therapy in ARASENS. In ARASENS, ADT + docetaxel + darolutamide significantly reduced the risk of death by 32.5% (HR 0.68, 95% CI 0.57-0.80) versus ADT + docetaxel + placebo in patients with mHSPC.1
Presented by Zachary Klaassen, MD, MSc
Zachary Klaassen, MD, MSc, presented a post-hoc sensitivity analysis from the phase III ARASENS trial evaluating the overall survival benefit of darolutamide versus placebo, in combination with androgen deprivation therapy (ADT) plus docetaxel, for patients with metastatic hormone sensitive prostate cancer (mHSPC), after accounting for subsequent therapy received.
Presented by Joan Carles Galceran, MD, PhD
Joan Carles Galceran, MD, PhD, discusses a subgroup analysis of ARASENS assessing age-related efficacy and safety of darolutamide + ADT and docetaxel in patients with metastatic hormone-sensitive prostate cancer (mHSPC).
Presented by Michael Ong, MD, FRCPC
The 2025 American Society of Clinical Oncology (ASCO) Genitourinary (GU) Annual Symposium held in San Francisco, CA between February 13–15, 2025 was host to a prostate cancer poster session. Dr. Michael Ong presented an ad hoc analysis of the phase III ARASENS trial evaluating 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).
Presented by Rana McKay, MD
 The 2025 American Society of Clinical Oncology Genitourinary (ASCO GU) cancers symposium held in San Francisco, CA between February 13th and 15th 2025, was host to the Poster Session A: Prostate Cancer. Dr. Rana McKay presented Clinical use and outcomes of androgen-receptor pathway inhibitors triplet therapy for metastatic hormone-sensitive prostate cancer (ARAAT).
Presented by Soumyajit Roy, MBBS, MSc
Dr. Soumyajit Roy presented the results of an individual patient data meta-analysis of early PSA nadir in the ARASENS, LATITUDE, and TITAN trials.
Presented by Marc-Oliver Grimm, MD
Marc-Oliver Grimm, MD, discussed a post hoc analysis of ARASENS discussing post-progression survival of patients with metastatic hormone-sensitive prostate cancer (mHSPC) who received darolutamide or placebo.
Presented by Bertrand Tombal, MD, PhD
The 2024 European Association of Urology (EAU) annual meeting featured a session on metastatic prostate cancer, and a presentation by Dr. Bertrand Tombal discussing the efficacy and safety of darolutamide in combination with ADT and docetaxel in European patients from the phase 3 ARASENS trial.
Presented by Daniel J. George, MD
 The 2024 Southeastern Section of the AUA (SESAUA) annual meeting featured a prostate cancer session and a presentation by Dr. Daniel George discussing the association of PSA response and overall survival in patients with metastatic hormone-sensitive prostate cancer (mHSPC) in the phase 3 ARASENS trial.
Presented by Evan Goldfischer, MD, MBA, FACS
The 2024 Southeastern Section of the AUA (SESAUA) annual meeting featured a prostate cancer session and a presentation by Dr. Evan Goldfischer discussing efficacy and safety by disease volume and risk in the phase 3 ARASENS trial.
Presented by Alicia K. Morgans, MD, MPH
The 2024 American Society of Clinical Oncology Genitourinary (ASCO GU) cancers symposium held in San Francisco, CA between January 25th and 27th was host to a prostate cancer poster session. Dr. Alicia Morgan presented the results of a secondary analysis of ARASENS assessing the rate of hospitalization and length of hospital stay during and post-docetaxel for darolutamide-treated patients with metastatic hormone sensitive prostate cancer (mHSPC).
Presented by Neal Shore, MD, FACS
The 2024 American Society of Clinical Oncology Genitourinary (ASCO GU) cancers symposium held in San Francisco, CA was host to a prostate cancer poster session. Dr. Neal Shore presented the results of a post-hoc, sensitivity analysis from ARASENS accounting for subsequent therapy received, to evaluate the overall survival (OS) benefit with darolutamide versus placebo, in combination with androgen deprivation therapy plus docetaxel, for patients with metastatic hormone sensitive prostate cancer (mHSPC).
Presented by  Fred Saad, MD, FRCS
During the 2023 ESMO annual congress Dr. Fred Saad presented the results of a secondary analysis of ARASENS evaluating PSA outcomes with darolutamide + docetaxel + ADT triplet therapy in patients with high- and low-volume metastatic hormone-sensitive prostate cancer (mHSPC).
Presented by Matthew R. Smith, MD, PhD
The 2023 ASCO annual meeting included a prostate cancer session, featuring a presentation by Dr. Matthew Smith discussing darolutamide and time to pain progression by disease volume in the ARASENS trial.
Presented by Fred Saad, MD, FRSC
At the 2023 AUA annual meeting, Dr. Fred Saad discussed rapid, durable and deep PSA response following the addition of darolutamide to ADT and docetaxel in ARASENS. Dr. Saad and colleagues reported on PSA responses and kinetics data from ARASENS.
Presented by Neal D. Shore, MD, FACS
At the 2023 AUA annual meeting Dr. Neal Shore discussed the efficacy and safety of darolutamide in combination with ADT and docetaxel in the North American population in ARASENS. Dr. Shore and colleagues reported clinical outcomes in North American patients in ARASENS.
Presented by Arash Rezazadeh, MD
The 2023 GU ASCO annual meeting included a session on prostate cancer, featuring a presentation by Dr. Arash Rezazadeh discussing dosing, safety, and pharmacokinetics of combination therapy with darolutamide, ADT, and docetaxel in patients with metastatic hormone-sensitive prostate cancer (mHSPC) in the ARASENS study.
Presented by Maha H. A. Hussain, MD, FACP, FASCO
The 2023 GU ASCO annual meeting included a session on advanced prostate cancer, specifically new targets, new drugs, and new victories, featuring a presentation by Dr. Maha Hussain discussing efficacy and safety of darolutamide in combination with ADT and docetaxel by disease volume and disease risk in the phase 3 ARASENS study.
Presented by Karim Fizazi, MD, Ph.D
The 2022 ESMO annual meeting featured a prostate cancer session, including a presentation by Dr. Karim Fizazi discussing quality of life and patient-relevant endpoints with darolutamide in the phase 3 ARASENS study.
Presented by Bertrand Tombal, MD, PhD
Dr. Bertrand Tombal discussed results from the Phase 3 ARASENS trial evaluating overall survival with darolutamide versus placebo in combination with androgen deprivation therapy (ADT) and docetaxel by stratification factors.
Presented by Professor Jan Philipp Radtke, MD, MBA
Professor Jan Philipp Radtke led a discussion session following Dr. Tombal’s presentation: “Overall Survival with Darolutamide versus placebo in combination with androgen deprivation therapy and docetaxel by stratification factors in the phase 3 ARASENS trial”.
Presented by Fred Saad, MD, FRCS
The 2022 ASCO annual meeting featured a session on prostate cancer, including a presentation by Dr. Fred Saad discussing the association of PSA response and overall survival in patients with mHSPC from the phase 3 ARASENS trial.
Presented by E. David Crawford, MD
In a podium presentation in the Late-Breaking Abstracts session at the 2022 American Urologic Association Annual Meeting held in New Orleans and virtually, Dr. David Crawford presented a post hoc analysis of safety and adverse events among men with metastatic hormone-sensitive prostate cancer (mHSPC) treated in the context of the ARASENS trial (NCT02799602).
Presented by Elisabeth I. Heath, MD
(UroToday.com) Dr. Elisabeth Heath provided a discussion following presentations from Dr. Smith and Dr. Merseberger on the ARASENS and PRESIDE trials, respectively In an oral abstract presentation on the first day of the American Society for Clinical Oncology (ASCO) Genitourinary Cancer Symposium 2022.
Presented by Matthew Raymond Smith, PhD, MD

Darolutamide is a related, but structurally distinct, androgen receptor inhibitor which has demonstrated improved metastasis-free survival and overall survival in patients with nonmetastatic castration-resistant prostate cancer (CRPC). In an oral abstract presentation Dr. Smith presented the first results of the ARASENS trial which examined darolutamide in combination with docetaxel and ADT

Presented by Matthew R. Smith, MD, PhD
(UroToday.com) In this presentation, Dr. Smith presented results of the ARASENS study. ARASENS is a randomized phase 3 trial of darolutamide versus placebo in combination with docetaxel and androgen-deprivation therapy (ADT) for metastatic hormone-sensitive prostate cancer (mHSPC). 
Presented by Matthew Raymond Smith, MD, PhD
San Francisco, CA (UroToday.com) The addition of either docetaxel or abiraterone acetate plus prednisone to androgen deprivation therapy (ADT) improves overall survival (OS) compared with ADT alone in men with metastatic hormone sensitive prostate cancer (mHSPC). It is hypothesized that other androgen receptor (AR)-targeted therapies could be combined with docetaxel for mHSPC.
Presented by Bertrand Tombal, MD
Madrid, Spain (UroToday.com) Dr. Tombal and colleagues presented their phase III trial design assessing darolutamide in males with metastatic hormone-sensitive prostate cancer (mHSPC). It is well established that androgen-deprivation therapy (ADT) demonstrates antitumor activity in mHSPC with prolonged disease control, albeit resistance ultimately occurs and patients die of castration resistant prostate cancer (CRPC) with up to half of patients developing CRPC in <5 years.
Presented by Matthew R. Smith, MD, PhD
Chicago, IL (UroToday.com) Dr. Matthew Smith and colleagues presented the design for their trial, the ARASENS phase III trial assessing ODM-201 (darolutamide) in men with metastatic hormone-sensitive prostate cancer at the prostate cancer poster session at ASCO 2017. Even with first line therapy (ADT +/- docetaxel or abiraterone, based on the LATITUDE and STAMPEDE studies presented this week), most patients with metastatic hormone-sensitive prostate cancer (mHSPC) progress to castration-resistant prostate cancer (CRPC).
Publications
Peer-Reviewed Journal Abstracts

We assessed the impact of granulocyte colony-stimulating factor (G-CSF) use and docetaxel relative dose intensity (RDI) on the safety profile of the ARASENS (NCT02799602) triplet regimen with darolutamide in patients with metastatic hormone-sensitive prostate cancer.

Prostate cancer is typically a disease of older men. As patients age, they develop comorbidities and require more medications, which may adversely affect or be affected by prostate cancer treatments.

Darolutamide + docetaxel + androgen-deprivation therapy (ADT) significantly improved overall survival (OS) and delayed time to disease progression versus docetaxel + ADT in ARASENS (NCT02799602).

Prostate-specific antigen (PSA) is a critical biomarker in metastatic hormone-sensitive prostate cancer (mHSPC), offering insights into disease progression and treatment efficacy. An early PSA response to intensified therapy has significant prognostic implications; however, traditional methods often categorize PSA levels and focus on fixed time points, neglecting its dynamic nature.

In the ARASENS trial (NCT02799602), darolutamide in combination with androgen-deprivation therapy (ADT) and docetaxel significantly reduced the risk of death by 32.5% (HR, 0.68; 95% CI, 0.57-0.80; P < .0001) compared with placebo plus ADT with docetaxel in patients with metastatic hormone-sensitive prostate cancer (mHSPC). We present efficacy and safety of darolutamide versus placebo in Black patients from ARASENS.

Darolutamide (NUBEQA®) is an oral androgen receptor inhibitor (ARi) that is approved for the treatment of metastatic hormone-sensitive prostate cancer (mHSPC) in combination with androgen deprivation therapy (ADT) and docetaxel.

Darolutamide is a potent androgen-receptor inhibitor that has been associated with increased overall survival among patients with nonmetastatic, castration-resistant prostate cancer. Whether a combination of darolutamide, androgen-deprivation therapy, and docetaxel would increase survival among patients with metastatic, hormone-sensitive prostate cancer is unknown.

Androgen deprivation therapy (ADT) is a mainstay initial treatment for advanced hormone-sensitive prostate cancer (HSPC), but disease progression to castration-resistant prostate cancer (CRPC) invariably occurs when patients do not succumb to another disease or comorbidity.

Press Releases
Official Announcements on Clinical Developments
Reno, Nevada (UroToday.com) -- Bayer will present new data for NUBEQA® (darolutamide) in prostate cancer at the upcoming American Urological Association (AUA) Annual Meeting taking place in Las Vegas from April 26-29, 2025. These data support the potential of NUBEQA as a treatment option across the prostate cancer disease spectrum and in diverse patient populations. NUBEQA is indicated in the U.S. for the treatment of adult patients with metastatic hormone-sensitive prostate cancer (mHSPC) in combination with docetaxel and for the treatment of adult patients with non-metastatic castration-resistant prostate cancer (nmCRPC).