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Article (Scientific journals)
Prognostic Value of the Circulating Tumor DNA Fraction in Metastatic Castration-resistant Prostate Cancer: Results from the ProBio Platform Trial.
Crippa, Alessio; De Laere, Bram; Discacciati, Andrea et al.
2025 • In European Urology Oncology
Peer Reviewed verified by ORBi
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https://hdl.handle.net/2268/331173
DOI
10.1016/j.euo.2025.02.002
PubMed
40263079
 

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ProBio ctDNA prognostic value Eur Urol Oncol 2025.pdf
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https://doi.org/10.1016/j.euo.2025.02.002
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Keywords :
Circulating tumor DNA; Dose-response; Platform trial; Prognostic biomarker; Prostate cancer
Abstract :
[en] [en] BACKGROUND AND OBJECTIVE: The aim of this study was to evaluate the prognostic value of undetectable circulating tumor DNA (ctDNA) and the dose-response relationship between ctDNA levels and survival outcomes in metastatic castration-resistant prostate cancer (mCRPC). METHODS: We analyzed data for patients enrolled in the ProBio trial up to November 2022 who received an androgen receptor pathway inhibitor or taxane. We compared survival outcomes between patients with undetectable ctDNA and those with detectable ctDNA randomized to physician's choice or investigational arms. Time to no longer clinically benefiting (NLCB) and overall survival (OS) were assessed using Bayesian survival models, with results reported as survival time ratios (STRs). Dose-response relationships were estimated using spike-at-zero models. KEY FINDINGS AND LIMITATIONS: A total of 220 patients were included, of whom 139 had detectable ctDNA (56 in the physician's choice arm, 83 in investigational arms) and 81 had undetectable ctDNA. In comparison to the undetectable ctDNA group, the physician's choice arm had 60% shorter time to NLCB (STR 0.40, 90% credible interval [CrI] 0.31-0.51) and 51% shorter OS (STR 0.49, 90% CrI 0.38-0.61). Similar results were observed in comparison to the investigational arms. Dose-response analysis revealed that the undetectable ctDNA group had twofold longer time to NLCB (STR 2.05, 90% CrI 1.66-2.57) and 1.6-fold longer OS (STR 1.63, 90% CrI 1.33-2.05) in comparison to the subgroup with a ctDNA fraction of 2.5%. Every 10-point increment in the ctDNA fraction corresponded to a 10% reduction in NLCB and OS times. CONCLUSIONS AND CLINICAL IMPLICATIONS: Undetectable ctDNA at baseline predicts superior prognosis in mCRPC, suggesting potential for treatment de-escalation and less intensive monitoring for this subgroup of patients. This trial is registered on ClinicalTrials.gov as NCT03903835.
Disciplines :
Oncology
Author, co-author :
Crippa, Alessio ✱;  Department of Medical Epidemiology and Biostatistics, Karolinska Institutet, Stockholm, Sweden
De Laere, Bram ✱;  Department of Medical Epidemiology and Biostatistics, Karolinska Institutet, Stockholm, Sweden, Department of Human Structure and Repair Ghent University, Ghent, Belgium
Discacciati, Andrea;  Department of Medical Epidemiology and Biostatistics, Karolinska Institutet, Stockholm, Sweden
Larsson, Berit;  Department of Medical Epidemiology and Biostatistics, Karolinska Institutet, Stockholm, Sweden
Persson, Maria;  Department of Medical Epidemiology and Biostatistics, Karolinska Institutet, Stockholm, Sweden
Johansson, Susanne;  Department of Medical Epidemiology and Biostatistics, Karolinska Institutet, Stockholm, Sweden
D'hondt, Sanne;  Clinical Trial Unit, Health, Innovation and Research Institute University Hospital Ghent, Ghent, Belgium
Hjälm-Eriksson, Marie;  Department of Oncology, Capio Saint Göran's Hospital, Stockholm, Sweden
Pettersson, Linn;  Department of Oncology, Länssjukhuset Ryhov, Jönköping, Sweden
Enblad, Gunilla;  Department of Oncology, Uppsala University Hospital, Uppsala, Sweden
Ullén, Anders;  Department of Oncology, Karolinska University Hospital, Stockholm, Sweden
Lumen, Nicolaas;  Department of Urology, University Hospital Ghent, Ghent, Belgium
Karlsson, Camilla Thellenberg;  Department of Oncology, University Hospital Umeå, Umeå, Sweden
Sandzén, Johan;  Department of Oncology, Centralsjukhuset Karlstad, Karlstad, Sweden
Jänes, Elin;  Department of Oncology, Sundsvalls Sjukhus, Sundsvall, Sweden
Ghysel, Christophe;  Department of Urology, AZ Sint Jan Brugge-Oostende AV, Brugge, Belgium
Olsson, Martha;  Department of Oncology, Centrallasarettet Växjö, Växjö, Sweden
Sautois, Brieuc  ;  Université de Liège - ULiège > Département de pharmacie
Schatteman, Peter;  Department of Urology, Onze Lieve Vrouwziekenhuis, Aalst, Belgium
Roock, Wendy De;  Department of Oncology, Ziekenhuis Oost-Limburg, Genk, Belgium
Bruwaene, Siska Van;  Department of Urology, AZ Groeninge, Kortrijk, Belgium
Verbiene, Ingrida;  Department of Oncology, Falu Lasarett, Falu, Sweden
Darras, Jochen;  Department of Urology, AZ Damiaan, Oostende, Belgium
Everaert, Els;  Department of Oncology, Vitaz campus Sint-Niklaas Lodewijk, Sint-Niklaas, Belgium
De Maeseneer, Daan;  Department of Oncology, AZ Sint-Lucas, Brugge, Belgium
Anden, Mats;  Department of Oncology, Länssjukhuset i Kalmar, Kalmar, Sweden
Strijbos, Michiel;  Department of Oncology, GZA Sint-Augustinus, Antwerp, Belgium
Luyten, Daisy;  Department of Oncology, Virga Jessa, Hasselt, Belgium
Mortezavi, Ashkan;  Department of Urology, University Hospital Zurich, Zurich, Switzerland
Oldenburg, Jan;  Akershus University Hospital, Nordbyhagen, Norway
Ost, Piet;  Department of Human Structure and Repair Ghent University, Ghent, Belgium, Department of Radiation Oncology, GZA Sint-Augustinus, Antwerp, Belgium
Lindberg, Johan ✱;  Department of Medical Epidemiology and Biostatistics, Science for Life Laboratory, Karolinska Institutet, Stockholm, Sweden
Grönberg, Henrik ✱;  Department of Medical Epidemiology and Biostatistics, Karolinska Institutet, Stockholm, Sweden, Prostatacancer Centrum, Capio S:t Görans Sjukhus, Stockholm, Sweden. Electronic address: henrik.gronberg@ki.se
Eklund, Martin ✱;  Department of Medical Epidemiology and Biostatistics, Karolinska Institutet, Stockholm, Sweden
ProBio Investigators
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✱ These authors have contributed equally to this work.
Language :
English
Title :
Prognostic Value of the Circulating Tumor DNA Fraction in Metastatic Castration-resistant Prostate Cancer: Results from the ProBio Platform Trial.
Publication date :
21 April 2025
Journal title :
European Urology Oncology
eISSN :
2588-9311
Publisher :
Elsevier, Netherlands
Peer reviewed :
Peer Reviewed verified by ORBi
Additional URL :
https://api.elsevier.com/content/article/PII:S2588931125000379?httpAccept=text/xml
Available on ORBi :
since 25 April 2025

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