Clinical Trial Protocol for ProBio: An Outcome-adaptive and Randomised Multiarm Biomarker-driven Study in Patients with Metastatic Prostate Cancer

Bram De Laere; Alessio Crippa; Andrea Discacciati; Berit Larsson; Jan Oldenburg; Ashkan Mortezavi; Piet Ost; Martin Eklund; Johan Lindberg; Henrik Grönberg; ProBio Investigators

doi:10.1016/j.euf.2022.03.005

Clinical Trial Protocol for ProBio: An Outcome-adaptive and Randomised Multiarm Biomarker-driven Study in Patients with Metastatic Prostate Cancer

Eur Urol Focus. 2022 Nov;8(6):1617-1621. doi: 10.1016/j.euf.2022.03.005. Epub 2022 Mar 19.

Authors

Affiliations

¹ Department of Human Structure and Repair, Ghent University, Ghent, Belgium; Department of Medical Epidemiology and Biostatistics, Karolinska Institutet, Stockholm, Sweden. Electronic address: bramdelaere@gmail.com.
² Department of Medical Epidemiology and Biostatistics, Karolinska Institutet, Stockholm, Sweden.
³ Department of Oncology, Akershus University Hospital, Ahus, Norway.
⁴ Department of Urology, University Hospital Basel, Basel, Switzerland.
⁵ Department of Human Structure and Repair, Ghent University, Ghent, Belgium; Department of Radiation Oncology, GZA Sint-Augustinus, Antwerp, Belgium.
⁶ Department of Medical Epidemiology and Biostatistics, Karolinska Institutet, Stockholm, Sweden; Department of Oncology, Capio S:t Görans Sjukhus, Stockholm, Sweden.

PMID: 35317973
DOI: 10.1016/j.euf.2022.03.005

Abstract

ProBio is an outcome-adaptive, multiarm, multiple-assignment randomised, biomarker-driven platform trial in men with metastatic castration-resistant prostate cancer. Here we describe the amended clinical protocol, focusing on expansion of the trial to include patients with de novo metastatic hormone-sensitive prostate cancer.

Trial registration: ClinicalTrials.gov NCT03903835.

Keywords: Genomics; Liquid biopsy; Outcome-adaptive; Platform trial; Precision medicine; mCRPC; mHSPC.

Publication types

Clinical Trial Protocol
Research Support, Non-U.S. Gov't

MeSH terms

Adaptive Clinical Trials as Topic
Biomarkers*
Humans
Male
Prostatic Neoplasms* / therapy

Substances

Biomarkers

Associated data

ClinicalTrials.gov/NCT03903835