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. 2025 Apr;21(10):1157-1170.
doi: 10.1080/14796694.2025.2476929. Epub 2025 Mar 25.

Prostate-specific antigen (PSA) response with darolutamide in metastatic hormone-sensitive prostate cancer and its impact on treatment outcomes in the ARASENS trial: a plain language summary

Fred Saad  1 , Maha H A Hussain  2 , Bertrand Tombal  3 , Karim Fizazi  4 , Ken Mastris  5   6 , Thomas Flannery  7   8 , Matthew R Smith  9
Affiliations

Prostate-specific antigen (PSA) response with darolutamide in metastatic hormone-sensitive prostate cancer and its impact on treatment outcomes in the ARASENS trial: a plain language summary

Fred Saad et al. Future Oncol. 2025 Apr.
No abstract available

Plain language summary

What is this summary about?This summary describes the results from an additional (or post-hoc) analysis of the ARASENS trial in which researchers studied the impact of prostate-specific antigen (PSA) response on treatment outcomes, including how long patients lived, in metastatic hormone-sensitive prostate cancer (mHSPC). mHSPC is a form of prostate cancer that has spread to other parts of the body but can be treated with hormone therapy.The ARASENS trial included 1,305 patients with mHSPC. In this trial, combining darolutamide with two other medications called androgen deprivation therapy (ADT) and docetaxel increased the chances of survival and lowered the risk of death by 32.5%. The percentage of patients reporting medical problems, also called adverse events, was similar to those who received placebo with ADT and docetaxel.What were the PSA results?More than double the patients who received darolutamide, ADT, and docetaxel achieved a deep PSA response compared with those who received placebo, ADT, and docetaxel.Patients who received darolutamide with ADT and docetaxel had more time before their PSA levels increased (durable PSA response) compared with those who received a placebo with ADT and docetaxel.Compared with patients who did not achieve a deep PSA response in the darolutamide group, patients who had a deep PSA response lived longer, had more time before their cancer stopped responding to hormone treatment such as ADT, and had more time before their PSA levels increased.What do these results mean?These results show an important link between a deep PSA response and improved treatment outcomes. They also highlight the importance of monitoring PSA levels and aiming to achieve a deep PSA response at any time during treatment for mHSPC. These findings suggest that triple therapy of darolutamide plus ADT and docetaxel could be considered for all patients with mHSPC, including those with low-volume disease.[Box: see text].

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Conflict of interest statement

Fred Saad certifies that all conflicts of interest, including specific financial interests and relationships and affiliations relevant to the subject matter or materials discussed in the manuscript (e.g. employment/affiliation, grants or funding, consultancies, honoraria, stock ownership or options, expert testimony, royalties, or patents filed, received, or pending), are the following: Fred Saad has a consulting or advisory role for AbbVie, Advanced Accelerator Applications, Astellas Pharma, AstraZeneca/MedImmune, Bayer, Janssen Oncology, Myovant Sciences, Novartis, Pfizer, Knight Therapeutics, and Sanofi; has received honoraria from AbbVie, Advanced Accelerator Applications, Astellas Pharma, AstraZeneca, Bayer, Bristol-Myers Squibb, Janssen Oncology, Knight Therapeutics, Merck, Myovant Sciences, Novartis, Pfizer, and Sanofi; and has received institutional research funding from Advanced Accelerator Applications, Astellas Pharma, AstraZeneca, Bayer, Bristol-Myers Squibb, Janssen Oncology, Merck, Novartis, Pfizer, and Sanofi. Maha H.A. Hussain has received honoraria from UroToday, Merck, Astellas Pharma, AstraZeneca, Precisca, Medscape Zero, Targeted Oncology, Great Debates and Updates in GU Oncology, and Clinical Care Options; has a consulting or advisory role for Pfizer, Novartis, Merck, Janssen, Tempus, Bayer, AstraZeneca, GSK, and Convergent Therapeutics; has received institutional research funding from Genentech, Pfizer, PCCTC, AstraZeneca, Bayer, and Arvinas; and has interest in patents UM-14437/US-1/PRO 60/923,385; UM-14437/US-2/ORD 12/101,753; US 8,185,186; EP 08745653.9; CA 2683805; US 13/362,500; US 8,185,186; 224,990/10-016P2/311,733 61/481/671; 11764665.4-1,464; and 11764656.2-1,464 (Open Payments link: https://openpaymentsdata.cms.gov/physician/146932). Bertrand Tombal has received honoraria from Amgen, Astellas, Bayer, Ferring, Janssen, Myovant, Pfizer, and Sanofi; has a consulting or advisory role for Astellas, Bayer, Ferring, Janssen, Myovant, Pfizer/Astellas, Sanofi, Steba, and Takeda; participates in speaker bureaus for Amgen, Astellas, and Janssen; and has received travel and accommodation expenses from Amgen, Astellas, Bayer, Ferring, Janssen, and Sanofi. Karim Fizazi has received institutional honoraria from Janssen, Sanofi, Astellas Pharma, and Bayer; has a consulting or advisory role for Janssen Oncology, Astellas Pharma, Sanofi, AstraZeneca, ESSA, Amgen, Bristol-Myers Squibb, Clovis Oncology, Novartis, and Pfizer; has a consulting or advisory role for Bayer and Orion; and has received travel and accommodation expenses from Janssen, Merck Sharp & Dohme, and AstraZeneca. Matthew R. Smith has a consulting or advisory role for Bayer, Janssen Oncology, Amgen, Pfizer, Lilly, Novartis, and Astellas Pharma; and has received institutional research funding from Janssen Oncology, Bayer, Lilly, ESSA, and ORIC Pharmaceuticals. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.

Medical writing and editorial assistance in the development of this summary was provided by Krystelis Ltd. Medical writing and editorial assistance was supported by Bayer.

Patient reviewers on this PLSP have received honorarium from Future Oncology for their review work but have no other relevant financial relationships to disclose.

Peer reviewers on this manuscript have no relevant financial or other relationships to disclose.

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