Amarnath Challapali
Real world prospective evaluation of clinical outcomes in patients with non-metastatic castrate resistant prostate cancer treated with darolutamide
Challapali, Amarnath; Rennison, Emily; White, Paul; Elumalai, Thiraviyam; Parikh, Omi; Vickers, Alexander; Birtle, Alison Jane; Brocklehurst, Andrew; Bhana, Rajanee; Wickramasinghe, Kanchana; Jayaprakash, Kamalram Thippu; Gray, Emma; Sephton, Matthew; Bowzyk Al-Naeeb, Anna; Foulstone, Emily; Soundy, Alexandra; Ashurst, Lauren; Bahl, Amit
Authors
Emily Rennison
Paul White Paul.White@uwe.ac.uk
Professor in Applied Statistics
Thiraviyam Elumalai
Omi Parikh
Alexander Vickers
Alison Jane Birtle
Andrew Brocklehurst
Rajanee Bhana
Kanchana Wickramasinghe
Kamalram Thippu Jayaprakash
Emma Gray
Matthew Sephton
Anna Bowzyk Al-Naeeb
Emily Foulstone
Alexandra Soundy
Lauren Ashurst
Amit Bahl
Abstract
Background: The RECORD Study is a real world data, prospective evaluation of clinical outcomes in patients with nmCRPC treated with Darolutamide. This study will increase the understanding of treatment response and management and in particular inform regarding use of next generation imaging in this setting.
Methods: Patient data from 9 UK centres was collected based on the recommendation of NICE for Darolutamide as an option for the treatment of non-metastatic castrate resistant prostate cancer (nmCRPC) from November 2020. Data cut-off was 15 September 2022. The study is ongoing.
Results: 87 patients were analysed with a median age of 78 (range 61-92). Median pre-treatment PSA and PSA doubling time (PSAdT) were 13 (range 1.99-110.6) mg/L and 5.05 (range 0.6 - 10) months. 42 patients (49.4%) had pre-treatment PSAdT of <6 months and 43 (50.6%) patients had PSAdT of ≥6 months (2 patients had no pre-treatment PSAdT data). 6 patients (6.90%) had next generation imaging prior to initiation of Darolutamide. Median duration of treatment on Darolutamide was 17 months for patients with pre-treatment PSAdT <6 months but median duration had not been reached for patients with pre-treatment PSAdT ≥6 months after 24 months of treatment, a significant difference p=0.018 (HR=0.385, 95% CI 0.17-0.88). 30 patients have come off treatment so far (34.5%); 21 (70%) for disease progression, 5 (16%) for a medical cause unrelated to the drug (e.g. COVID infection, reduced performance status secondary to pre-existing Parkinson's), 3 (10%) for unacceptable toxicity (rash, Grade3 fatigue, muscle aches, memory issues), and 1 patient died (unrelated).
Conclusions: In the RECORD study, predominantly the diagnosis of nmCRPC is based on conventional imaging. The majority of patients respond and tolerate Darolutamide well, comparable with the ARAMIS trial. There is a significant difference between time on Darolutamide for those with pre-treatment PSAdT of <6 months compared with ≥6 months. Further long-term toxicity, MFS and OS data will continue to be collected prospectively within the study.
Presentation Conference Type | Conference Paper (published) |
---|---|
Acceptance Date | Feb 20, 2023 |
Online Publication Date | Feb 21, 2023 |
Publication Date | Feb 20, 2023 |
Deposit Date | Feb 27, 2023 |
Publicly Available Date | Feb 21, 2024 |
Journal | Journal of Clinical Oncology |
Print ISSN | 0732-183X |
Electronic ISSN | 1527-7755 |
Publisher | American Society of Clinical Oncology |
Peer Reviewed | Not Peer Reviewed |
Volume | 41 |
Issue | 6_suppl |
Pages | 335 |
DOI | https://doi.org/10.1200/JCO.2023.41.6_suppl.335 |
Keywords | prostate cancer; darolutamide; cancer research; oncology |
Public URL | https://uwe-repository.worktribe.com/output/10486956 |
Publisher URL | https://ascopubs.org/doi/abs/10.1200/JCO.2023.41.6_suppl.335?af=R |
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Real world prospective evaluation of clinical outcomes in patients with non-metastatic castrate resistant prostate cancer treated with darolutamide
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Copyright Statement
This is the authors accepted version of ‘Challapali, A., Rennison, E., White, P., Elumalai, T., Parikh, O., Vickers, A., …Bahl, A. (in press). Real world prospective evaluation of clinical outcomes in patients with non-metastatic castrate resistant prostate cancer treated with darolutamide. Journal of Clinical Oncology, 41(no. 6_suppl), 335 – 335’.
DOI: https://doi.org/10.1200/JCO.2023.41.6_suppl.335
The final published version is available here: https://ascopubs.org/doi/pdf/10.1200/JCO.2023.41.6_suppl.335?role=tab
Copyright © 2023, by the American Society of Clinical Oncology
Real world prospective evaluation of clinical outcomes in patients with non-metastatic castrate resistant prostate cancer treated with darolutamide
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Document
Licence
http://www.rioxx.net/licenses/all-rights-reserved
Publisher Licence URL
http://www.rioxx.net/licenses/all-rights-reserved
Copyright Statement
This is the authors accepted version of ‘Challapali, A., Rennison, E., White, P., Elumalai, T., Parikh, O., Vickers, A., …Bahl, A. (in press). Real world prospective evaluation of clinical outcomes in patients with non-metastatic castrate resistant prostate cancer treated with darolutamide. Journal of Clinical Oncology, 41(no. 6_suppl), 335 – 335’.
DOI: https://doi.org/10.1200/JCO.2023.41.6_suppl.335
The final published version is available here: https://ascopubs.org/doi/pdf/10.1200/JCO.2023.41.6_suppl.335?role=tab
Copyright © 2023, by the American Society of Clinical Oncology
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