Clinical Trial Protocol for ProBio-mHSPC: A ctDNA-driven De-escalation and Intensification Platform Trial for Metastatic Hormone-sensitive Prostate Cancer.

Prostate Biomarkers trial in metastatic hormone-sensitive prostate cancer (mHSPC) tests whether circulating tumor deoxyribonucleic acid (ctDNA) can personalize first-line treatment for mHSPC by safely de-escalating therapy in patients with undetectable ctDNA and by intensifying biomarker-matched treatment in ctDNA-detectable disease, aiming to preserve outcomes while reducing toxicity and improving quality of life.

European urology focus. 2026 May 12 [Epub ahead of print]

Bram De Laere, Alessio Crippa, Andrea Discacciati, Ashkan Mortezavi, Christoph Müller, Andreas Røder, Antti Rannikko, Piet Ost, Martin Eklund, Johan Lindberg, Henrik Grönberg, ProBio Investigators

Department of Medical Epidemiology and Biostatistics, Karolinska Institutet, Stockholm, Sweden; Department of Human Structure and Repair Ghent University, Ghent, Belgium., Department of Medical Epidemiology and Biostatistics, Karolinska Institutet, Stockholm, Sweden., Universitätsspital Zürich, Zürich, Switzerland., Cancer Treatment Centre, Sorlandet Hospital, Kristiansand, Norway., Urological Research Unit, Department of Urology, Center for Cancer and Organ Diseases Copenhagen University Hospital - Rigshospitalet, Denmark; Department of Clinical Medicine, University of Copenhagen, Copenhagen, Denmark., Research Program in Systems Oncology, Research Programs Unit and iCAN-Digital Precision Cancer Medicine Flagship, Faculty of Medicine, University of Helsinki, Helsinki, Finland; Department of Urology, Helsinki University Hospital, Helsinki, Finland., Department of Human Structure and Repair Ghent University, Ghent, Belgium; Department of Radiation Oncology, Iridium Network, Wilrijk, Belgium., Department of Medical Epidemiology and Biostatistics, Karolinska Institutet, Stockholm, Sweden. Electronic address: .