ProBio: An outcome-adaptive and randomised multi-arm biomarker driven study in patients with metastatic prostate cancer

The lack of treatment-predictive biomarkers is an unmet clinical need in metastatic prostate cancer leading to inferior clinical outcomes, overtreatment and accelerating costs.

The ProBio study (NCT03903835) is an ongoing randomized trial that builds on a novel adaptive study design and prospectively evaluates treatment predictive biomarker signatures in a large network of over 35 study centers in Europe.

By using ProBio we will be able to rapidly evaluate both new and old drugs in subsets of patients with similar genomic biomarker.

If successful, patients with prostate cancer will get individualized treatment based on treatment-predictive genomic biomarker signatures in the near future.To test this hypothesis, we will use a multiphase randomized study using an outcome-adaptive multi-arm biomarker-driven study design.

We have the following main aims: To investigate if treatment decisions based on a biomarker signature identified by sequencing circulating tumor DNA improves progression free survival (primary endpoint)To ultimately show that the ProBio concept is a model for collaboration between academia and industry in the evaluation of new drugs in prostate cancer