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

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

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

Bram De Laere et al. Eur Urol Focus. 2022 Nov.

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.

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