Biomarkers Consortium – NiP-Metastatic Prostate Cancer

Overview

Metastatic castration-resistant prostate cancer (mCRPC) is the second leading cause of cancer death of American men. Over 80% of these patients have metastases to the bone; for those with non-osseous spread, over 80% of soft tissue metastases are nodal. In a bone-dominant disease such as mCRPC, the lack of a surrogate endpoint for overall survival (OS) based on fully quantitative bone imaging has significantly impeded drug development and clinical care.

To develop new biomarkers that can deliver a readout of a drug’s activity earlier than OS, a whole-body imaging project is proposed that is non-invasive and addresses the challenges of tumor heterogeneity by capturing a patients’ entire tumor burden. A multi-variable response parameter will be created from the Cou302 trial database using imaging, serum biomarkers, clinical events, and progression and survival outcomes. A unique, fully quantitative response biomarker will be developed that is ready for validation in accordance with FDA guidelines for biomarker validation.

Goals

• Develop an analytically validated, fully automated computerized imaging platform that will detect bone and soft tissue disease on bone scintigraphy and CT scans, and will reflect post-treatment changes with a fully quantitative output.
• Develop an imaging endpoint that includes both bone and soft tissue disease, as well as disease volume, burden, and distribution, to reliably predict for overall survival (OS).
• Create a multi-variable prediction model that will predict for OS based on post-treatment imaging biomarker and serum and clinical biomarkers