ProBio: A Biomarker Driven Study in Patients With Metastatic Prostate Cancer

ProBio is an international, outcome-adaptive, multi-arm, open-label, multiple assignment randomized biomarker driven platform trial in patients with metastatic prostate cancer. Patients will be randomized to control or experimental treatment arms. Patients in the control arm will receive standard of care following national guidelines. Patients in the experimental arm will be randomized to treatments based on a biomarker signature inferred from diagnostic tissue or liquid biopsy profiling. The predefined biomarker signatures are tumor properties or mutations in genes/pathways with previously demonstrated clinical validity (e.g. prognostic value or association with treatment response). The biomarker signatures are identified using a hybridisation capture gene panel specifically designed for prostate cancer.

NCT Number	NCT03903835
Lead Sponsor	Karolinska Institutet Collaborators: The Swedish Research Council, Kom Op Tegen Kanker, Janssen Pharmaceutica N.V., Belgium, AstraZeneca, Cancerfonden
Conditions	Metastatic Castration-resistant Prostate Cancer (mCRPC), Metastatic Hormone-Sensitive Prostate Cancer (mHSPC)
Enrollment	750 participants
Start Date	2019-02-01
Primary Completion	2026-12 (estimated)
Study Completion	2026-12 (estimated)
Updated on ClinicalTrials.gov	2025-04-09