Publications
Articles and Abstracts
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.

Conference Coverage
Conference Highlights Written by Physician-Scientist
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 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 compared to 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). Darolutamide is a highly potent androgen receptor (AR) inhibitor with low blood-brain barrier penetration and limited drug-drug interactions.
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).
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