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. 2025 Feb 27;11(4):426-429.
doi: 10.1001/jamaoncol.2024.7051. Online ahead of print.

Plasma AR Alterations and Timing of Intensified Hormone Treatment for Prostate Cancer: the STAMPEDE Phase 3 Randomized Clinical Trial

Gianmarco Leone  1 , Francesco Orlando  2 , Peter Dutey-Magni  3 , Osvaldas Vainauskas  1 , Emily Grist  1 , Yari Ciani  2 , Sharanpreet Lall  1 , Suparna Thakali  1 , Anna Wingate  1 , Daniel Wetterskog  1 , Ashwin Sachdeva  4   5 , Matthew R Sydes  3 , Neil McPhail  6 , Thiagarajan Sreenivasan  7 , Joe M O'Sullivan  8 , Noel W Clarke  4 , Mahesh K B Parmar  3 , Louise C Brown  3 , Nicholas D James  9 , Francesca Demichelis  2 , Gerhardt Attard  1 ; STAMPEDE collaborators
Collaborators, Affiliations

Plasma AR Alterations and Timing of Intensified Hormone Treatment for Prostate Cancer: the STAMPEDE Phase 3 Randomized Clinical Trial

Gianmarco Leone et al. JAMA Oncol. .
No abstract available

Plain language summary

This randomized clinical trial explores whether hormone intensification at start of androgen deprivation therapy alters selection of androgen receptor (AR) gene alterations within the gene body and/or enhancer region.

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Conflict of interest statement

Conflict of Interest Disclosures: Dr Orlando reported being listed as co-inventor on a patent with claims covering the PCF-SELECT methodology (WO2022/25897). Mr Vainauskas reported a patent pending for P032355US. Dr Sachdeva reported grants from Cancer Research UK, Prostate Cancer UK, the Prostate Cancer Foundation, the National Institute for Health and Care Research, The Urology Foundation, and the John Black Charitable Foundation; personal fees from Veracyte and Ipsen; and travel support from AIRA Matrix outside the submitted work. Prof Sydes reported nonfinancial support from Astellas, Clovis Oncology, Janssen, Novartis, Pfizer, and Sanofi-Aventis during the conduct of the study, as well as speaker fees and travel support from Eli Lilly and Janssen outside the submitted work. Dr McPhail reported personal fees from GlaxoSmithKline, Eisai, and Ipsen, as well as travel support from Ipsen and Bayer outside the submitted work. Dr O’Sullivan reported personal fees from AAA, Bayer, Astellas, Novartis, Johnson & Johnson, and Sanofi outside the submitted work. Prof James reported personal fees from Astellas and Janssen, as well as institutional grants from Astellas and Janssen during the conduct of the study. Dr Demichelis reported grants from the AIRC Foundation for Cancer Research in Italy during the conduct of the study, as well as being listed as co-inventor on a patent with claims covering the PCF-SELECT methodology (WO2022/25897). Prof Attard reported grants from Cancer Research UK, the AIRC Foundation for Cancer Research in Italy, Prostate Cancer UK, the Prostate Cancer Foundation, Janssen, Astellas, the John Black Charitable Foundation, Prostate Cancer Research, and the Medical Research Council during the conduct of the study; personal fees from Janssen, Astellas, Blue Earth Therapeutics, Bayer, Novartis, AstraZeneca, and Sanofi, and grants from Novartis and Agilent outside the submitted work; and a patent for claims covering the PCF-SELECT methodology issued (WO2022/25897) and a patent for abiraterone acetate with royalties paid. No other disclosures were reported.

References

    1. Attard G, Murphy L, Clarke NW, et al. ; STAMPEDE investigators . Abiraterone acetate plus prednisolone with or without enzalutamide for patients with metastatic prostate cancer starting androgen deprivation therapy: final results from two randomised phase 3 trials of the STAMPEDE platform protocol. Lancet Oncol. 2023;24(5):443-456. doi:10.1016/S1470-2045(23)00148-1 - DOI - PMC - PubMed
    1. Romanel A, Gasi Tandefelt D, Conteduca V, et al. . Plasma AR and abiraterone-resistant prostate cancer. Sci Transl Med. 2015;7(312):312re10. doi:10.1126/scitranslmed.aac9511 - DOI - PMC - PubMed
    1. Takeda DY, Spisák S, Seo JH, et al. . A somatically acquired enhancer of the androgen receptor is a noncoding driver in advanced prostate cancer. Cell. 2018;174(2):422-432. doi:10.1016/j.cell.2018.05.037 - DOI - PMC - PubMed
    1. Orlando F, Romanel A, Trujillo B, et al. ; PEACE Consortium . Allele-informed copy number evaluation of plasma DNA samples from metastatic prostate cancer patients: the PCF_SELECT consortium assay. NAR Cancer. 2022;4(2):zcac016. doi:10.1093/narcan/zcac016 - DOI - PMC - PubMed
    1. Schiavon G, Hrebien S, Garcia-Murillas I, et al. . Analysis of ESR1 mutation in circulating tumor DNA demonstrates evolution during therapy for metastatic breast cancer. Sci Transl Med. 2015;7(313):313ra182. doi:10.1126/scitranslmed.aac7551 - DOI - PMC - PubMed