ProBio Adaptive, Randomized Multi-Arm Study Using Biomarkers to Guide Treatment in Men With Metastatic Prostate Cancer

What this Trial Is About

Researchers are evaluating treatments for patients with metastatic prostate cancer, including both hormone-sensitive and castration-resistant forms. This international trial uses biomarker signatures identified from tumor or liquid biopsies to guide treatment assignments. The study compares standard care based on national guidelines with experimental treatments tailored to genetic changes related to prostate cancer. It uses an adaptive design to assign treatments based on ongoing results to improve patient outcomes. Participants are randomized to either a control group receiving standard care or an experimental group receiving treatments matched to their biomarker profile. Experimental treatments include androgen receptor signaling inhibitors, taxane-based chemotherapy combined with AR inhibitors, PARP inhibitors, AKT inhibitors, and carboplatin, depending on the biomarker signature and disease stage. Patients progressing during the trial may be re-assigned up to three times to different treatments based on updated biomarker profiles. Throughout the study, patients undergo regular assessments including progression-free survival monitoring up to 60 months. Researchers also track treatment response rates, overall survival, patient-reported outcomes, cost-effectiveness, and safety through adverse event reports. An independent board regularly reviews data to evaluate treatment effectiveness and may modify treatment assignments accordingly. The trial aims to personalize therapy for metastatic prostate cancer based on genetic markers.

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