Darolutamide and survival in metastatic, hormone-sensitive prostate cancer: A patient and caregiver perspective and plain language summary of the ARASENS trial

Matthew R. Smith; Maha Hussain; Fred Saad; Karim Fizazi; Cora N. Sternberg; David Crawford; Jan Manarite; David Muslin; Thomas Farrington; Bertrand Tombal

doi:10.2217/fon-2022-0433

Darolutamide and survival in metastatic, hormone-sensitive prostate cancer: A patient and caregiver perspective and plain language summary of the ARASENS trial

Matthew R. Smith^*, Maha Hussain, Fred Saad, Karim Fizazi, Cora N. Sternberg, David Crawford, Jan Manarite, David Muslin, Thomas Farrington, Bertrand Tombal

^*Corresponding author for this work

Medicine, Hematology Oncology Division

Research output: Contribution to journal › Review article › peer-review

7 Scopus citations

Abstract

What is this summary about? This is a summary of a publication about the ARASENS trial, which was published in the New England Journal of Medicine in February 2022. The trial includes 1,306 men with a type of prostate cancer called metastatic, hormone-sensitive prostate cancer (also called mHSPC). In the trial, researchers wanted to learn if combining a treatment called darolutamide (also known by the brand name Nubeqa®) with two other medicines called androgen deprivation therapy (also called ADT) and docetaxel (brand name Taxotere®) could help treat patients with mHSPC better than placebo plus ADT and docetaxel. ADT with docetaxel is a treatment used for patients with mHSPC. Darolutamide is an approved treatment for a different type of prostate cancer called non-metastatic, castration-resistant prostate cancer (also called nmCRPC). What were the results? The trial results showed that combining darolutamide with ADT and docetaxel increased the chance of survival and lowered the risk of death by 32.5% compared to combining ADT and docetaxel with placebo instead. Compared to patients who received the placebo, patients who received darolutamide had a delay in: their cancer becoming castration-resistant worsening pain having cancer-related bone fractures or related symptoms needing additional therapies for cancer The percentage of trial patients who had medical problems during the trial, also called adverse events, was similar between trial patients who received darolutamide and those who received the placebo. What do the results of the study mean? Combining darolutamide with ADT and docetaxel helped treat trial patients with mHSPC better than placebo with ADT and docetaxel. Darolutamide in combination with ADT and docetaxel could be a treatment option for patients with mHSPC. Patients should always talk to their doctors and nurses before making any decisions about their treatment. This summary also includes perspectives on the ARASENS trial and prostate cancer from 3 members of the patient community. ClinicalTrials.gov NCT number: NCT02799602 </sec.

Original language	English (US)
Pages (from-to)	2585-2597
Number of pages	13
Journal	Future Oncology
Volume	18
Issue number	21
DOIs	https://doi.org/10.2217/fon-2022-0433
State	Published - Jul 2022

Funding

The authors would like to thank the patients in the ARASENS trial and their family members and caregivers. They would also like to thank the trial staff who cared for and supported the patients in the trial. Without all of these people working together, clinical studies could not move forward. Medical writing and editorial assistance in the development of this summary were provided by Kimbra Edwards, PhD and Scott Finger of the Center for Information & Study on Clinical Research Participation (CISCRP), a non-profit organization focused on educating and informing the public about clinical research participation. Medical writing and editorial assistance was supported by Bayer.

Keywords

Darolutamide
Drug development
Lay summary
Metastatic hormone-sensitive prostate cancer
Novel therapy
Overall survival
Plain language summary
Safety
Urological/prostate

ASJC Scopus subject areas

Oncology
Cancer Research

UN SDGs

This output contributes to the following UN Sustainable Development Goals (SDGs)

Access to Document

10.2217/fon-2022-0433

Cite this

Smith, M. R., Hussain, M., Saad, F., Fizazi, K., Sternberg, C. N., Crawford, D., Manarite, J., Muslin, D., Farrington, T., & Tombal, B. (2022). Darolutamide and survival in metastatic, hormone-sensitive prostate cancer: A patient and caregiver perspective and plain language summary of the ARASENS trial. Future Oncology, 18(21), 2585-2597. https://doi.org/10.2217/fon-2022-0433

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title = "Darolutamide and survival in metastatic, hormone-sensitive prostate cancer: A patient and caregiver perspective and plain language summary of the ARASENS trial",

abstract = "What is this summary about? This is a summary of a publication about the ARASENS trial, which was published in the New England Journal of Medicine in February 2022. The trial includes 1,306 men with a type of prostate cancer called metastatic, hormone-sensitive prostate cancer (also called mHSPC). In the trial, researchers wanted to learn if combining a treatment called darolutamide (also known by the brand name Nubeqa{\textregistered}) with two other medicines called androgen deprivation therapy (also called ADT) and docetaxel (brand name Taxotere{\textregistered}) could help treat patients with mHSPC better than placebo plus ADT and docetaxel. ADT with docetaxel is a treatment used for patients with mHSPC. Darolutamide is an approved treatment for a different type of prostate cancer called non-metastatic, castration-resistant prostate cancer (also called nmCRPC). What were the results? The trial results showed that combining darolutamide with ADT and docetaxel increased the chance of survival and lowered the risk of death by 32.5% compared to combining ADT and docetaxel with placebo instead. Compared to patients who received the placebo, patients who received darolutamide had a delay in: their cancer becoming castration-resistant worsening pain having cancer-related bone fractures or related symptoms needing additional therapies for cancer The percentage of trial patients who had medical problems during the trial, also called adverse events, was similar between trial patients who received darolutamide and those who received the placebo. What do the results of the study mean? Combining darolutamide with ADT and docetaxel helped treat trial patients with mHSPC better than placebo with ADT and docetaxel. Darolutamide in combination with ADT and docetaxel could be a treatment option for patients with mHSPC. Patients should always talk to their doctors and nurses before making any decisions about their treatment. This summary also includes perspectives on the ARASENS trial and prostate cancer from 3 members of the patient community. ClinicalTrials.gov NCT number: NCT02799602 ",

keywords = "Darolutamide, Drug development, Lay summary, Metastatic hormone-sensitive prostate cancer, Novel therapy, Overall survival, Plain language summary, Safety, Urological/prostate",

author = "Smith, {Matthew R.} and Maha Hussain and Fred Saad and Karim Fizazi and Sternberg, {Cora N.} and David Crawford and Jan Manarite and David Muslin and Thomas Farrington and Bertrand Tombal",

note = "Funding Information: The authors would like to thank the patients in the ARASENS trial and their family members and caregivers. They would also like to thank the trial staff who cared for and supported the patients in the trial. Without all of these people working together, clinical studies could not move forward. Medical writing and editorial assistance in the development of this summary were provided by Kimbra Edwards, PhD and Scott Finger of the Center for Information & Study on Clinical Research Participation (CISCRP), a non-profit organization focused on educating and informing the public about clinical research participation. Medical writing and editorial assistance was supported by Bayer. Publisher Copyright: {\textcopyright} 2022 The Authors.",

year = "2022",

month = jul,

doi = "10.2217/fon-2022-0433",

language = "English (US)",

volume = "18",

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Smith, MR, Hussain, M, Saad, F, Fizazi, K, Sternberg, CN, Crawford, D, Manarite, J, Muslin, D, Farrington, T & Tombal, B 2022, 'Darolutamide and survival in metastatic, hormone-sensitive prostate cancer: A patient and caregiver perspective and plain language summary of the ARASENS trial', Future Oncology, vol. 18, no. 21, pp. 2585-2597. https://doi.org/10.2217/fon-2022-0433

TY - JOUR

T1 - Darolutamide and survival in metastatic, hormone-sensitive prostate cancer

T2 - A patient and caregiver perspective and plain language summary of the ARASENS trial

AU - Smith, Matthew R.

AU - Hussain, Maha

AU - Saad, Fred

AU - Fizazi, Karim

AU - Sternberg, Cora N.

AU - Crawford, David

AU - Manarite, Jan

AU - Muslin, David

AU - Farrington, Thomas

AU - Tombal, Bertrand

N1 - Funding Information: The authors would like to thank the patients in the ARASENS trial and their family members and caregivers. They would also like to thank the trial staff who cared for and supported the patients in the trial. Without all of these people working together, clinical studies could not move forward. Medical writing and editorial assistance in the development of this summary were provided by Kimbra Edwards, PhD and Scott Finger of the Center for Information & Study on Clinical Research Participation (CISCRP), a non-profit organization focused on educating and informing the public about clinical research participation. Medical writing and editorial assistance was supported by Bayer. Publisher Copyright: © 2022 The Authors.

PY - 2022/7

Y1 - 2022/7

N2 - What is this summary about? This is a summary of a publication about the ARASENS trial, which was published in the New England Journal of Medicine in February 2022. The trial includes 1,306 men with a type of prostate cancer called metastatic, hormone-sensitive prostate cancer (also called mHSPC). In the trial, researchers wanted to learn if combining a treatment called darolutamide (also known by the brand name Nubeqa®) with two other medicines called androgen deprivation therapy (also called ADT) and docetaxel (brand name Taxotere®) could help treat patients with mHSPC better than placebo plus ADT and docetaxel. ADT with docetaxel is a treatment used for patients with mHSPC. Darolutamide is an approved treatment for a different type of prostate cancer called non-metastatic, castration-resistant prostate cancer (also called nmCRPC). What were the results? The trial results showed that combining darolutamide with ADT and docetaxel increased the chance of survival and lowered the risk of death by 32.5% compared to combining ADT and docetaxel with placebo instead. Compared to patients who received the placebo, patients who received darolutamide had a delay in: their cancer becoming castration-resistant worsening pain having cancer-related bone fractures or related symptoms needing additional therapies for cancer The percentage of trial patients who had medical problems during the trial, also called adverse events, was similar between trial patients who received darolutamide and those who received the placebo. What do the results of the study mean? Combining darolutamide with ADT and docetaxel helped treat trial patients with mHSPC better than placebo with ADT and docetaxel. Darolutamide in combination with ADT and docetaxel could be a treatment option for patients with mHSPC. Patients should always talk to their doctors and nurses before making any decisions about their treatment. This summary also includes perspectives on the ARASENS trial and prostate cancer from 3 members of the patient community. ClinicalTrials.gov NCT number: NCT02799602

AB - What is this summary about? This is a summary of a publication about the ARASENS trial, which was published in the New England Journal of Medicine in February 2022. The trial includes 1,306 men with a type of prostate cancer called metastatic, hormone-sensitive prostate cancer (also called mHSPC). In the trial, researchers wanted to learn if combining a treatment called darolutamide (also known by the brand name Nubeqa®) with two other medicines called androgen deprivation therapy (also called ADT) and docetaxel (brand name Taxotere®) could help treat patients with mHSPC better than placebo plus ADT and docetaxel. ADT with docetaxel is a treatment used for patients with mHSPC. Darolutamide is an approved treatment for a different type of prostate cancer called non-metastatic, castration-resistant prostate cancer (also called nmCRPC). What were the results? The trial results showed that combining darolutamide with ADT and docetaxel increased the chance of survival and lowered the risk of death by 32.5% compared to combining ADT and docetaxel with placebo instead. Compared to patients who received the placebo, patients who received darolutamide had a delay in: their cancer becoming castration-resistant worsening pain having cancer-related bone fractures or related symptoms needing additional therapies for cancer The percentage of trial patients who had medical problems during the trial, also called adverse events, was similar between trial patients who received darolutamide and those who received the placebo. What do the results of the study mean? Combining darolutamide with ADT and docetaxel helped treat trial patients with mHSPC better than placebo with ADT and docetaxel. Darolutamide in combination with ADT and docetaxel could be a treatment option for patients with mHSPC. Patients should always talk to their doctors and nurses before making any decisions about their treatment. This summary also includes perspectives on the ARASENS trial and prostate cancer from 3 members of the patient community. ClinicalTrials.gov NCT number: NCT02799602

KW - Darolutamide

KW - Drug development

KW - Lay summary

KW - Metastatic hormone-sensitive prostate cancer

KW - Novel therapy

KW - Overall survival

KW - Plain language summary

KW - Safety

KW - Urological/prostate

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ER -

Darolutamide and survival in metastatic, hormone-sensitive prostate cancer: A patient and caregiver perspective and plain language summary of the ARASENS trial

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Funding

Keywords

ASJC Scopus subject areas

UN SDGs

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