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PEER-TO-PEER CLINICAL CONVERSATIONS
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A Urologist's Perspective On Treatment with Darolutamide in the Metastatic Hormone-Sensitive Patient
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Neal Shore, MD, FACS
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| Neal Shore joins Alicia Morgans in discussing the approval of NUBEQA® (darolutamide) in the metastatic hormone-sensitive setting in combination with docetaxel and ADT. Drs. Shore and Morgans speak about the clinical implications of this approval from a urologist's perspective.
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| The Association of PSA Response and Overall Survival in Patients with mHSPC in the Phase 3 ARASENS Trial |
Fred Saad, MD, FRCS
Fred Saad joins Alicia Morgans in discussing the association between PSA response and overall survival (OS) in patients with metastatic hormone-sensitive prostate cancer (mHSPC) from the phase 3 ARASENS trial. |
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Practice Changing Data from ARASENS - Statistically Significant Overall Survival
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Neal Shore, MD, FACS, Bertrand Tombal, MD, Ph.D., and Fred Saad, MD, FRCS
Fred Saad, Bertrand Tombal, and Neal Shore join Alicia Morgans in a discussion on the results of the ARASENS trial which examined darolutamide in combination with docetaxel and ADT compared to docetaxel and ADT. They discuss the trial design, its endpoints, how it impacts practice in Canada, the US, and in Europe, and the ideal patient population for this treatment.
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| Darolutamide Approved for Patients with mHSPC |
Alicia Morgans, MD, MPH, Charles Ryan, MD
Drs. Charles Ryan and Alicia Morgans discuss the approval of NUBEQA® (darolutamide) tablets, for oral use for metastatic hormone-sensitive prostate cancer (mHSPC). The FDA has approved darolutamide in combination with docetaxel for adult patients with mHSPC. |
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| Enough is No Longer Enough |
| Alicia Morgans, MD, MPH |
| The treatment landscape for mHSPC has become increasingly complex during the last several years. Since 2014 we have been aware that combination treatment with androgen deprivation therapy and docetaxel chemotherapy is associated with improved overall survival in patients with mHSPC. Quality of life (QOL) data suggested that better control of the disease with intensified treatment was associated with similar QOL by 12 months after starting chemohormonal treatment. However, there remained a need to ensure that patients who were not candidates for chemotherapy, or who might not benefit sufficiently from chemotherapy, had an option to improve outcomes. |
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| Overall Safety and Incidences of Adverse Events by Time Interval with Darolutamide Plus Androgen-Deprivation Therapy and Docetaxel in the ARASENS Trial
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| E. David Crawford, MD
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| In a podium presentation in the Late-Breaking Abstracts session at the 2022 American Urologic Association Annual Meeting held in New Orleans and virtually, E. 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.
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| ARASENS Trial Overall Survival With Darolutamide Versus Placebo in Combination With ADT and Docetaxel for mHSPC |
| Matthew Smith, MD, Ph.D. |
| Matthew Smith presented the first results of the ARASENS trial which examined darolutamide in combination with docetaxel and ADT compared to docetaxel and ADT. Results of this trial were concurrently published in the New England Journal of Medicine. Among patients with mHSPC, early triplet combination therapy with darolutamide, docetaxel, and ADT significantly increased overall and improved key secondary endpoints compared with ADT and docetaxel alone with similar rates of treatment emergent adverse events between the two arms. |
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| Phase 3 ARASENS Trial Discussion - Darolutamide and Survival in Metastatic, Hormone-Sensitive Prostate Cancer
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| Jan Philipp Radtke, MD, MBA
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| The 37th Annual European Association of Urology Congress held in Amsterdam, Netherlands between July 1st, and 4th 2022 was host to the prostate cancer “Game-Changing Session”. 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”.
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| ARASENS Trial Overall Survival With Darolutamide Versus Placebo in Combination With ADT and Docetaxel for mHSPC - Discussion
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| Elisabeth I. Heath, MD, FACP
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| Elisabeth Heath provides a discussion of presentations from Dr. Matthew Smith and Dr.Axel Merseburger 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.
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