Developing and Validating a Blood Test Using Plasma Exosomal RNA to Predict Bone Metastasis in Prostate Cancer Before Treatment

What this Trial Is About

Researchers are investigating a new way to predict bone metastasis in prostate cancer using a blood test that analyzes plasma exosomal RNA. This test aims to serve as a non-invasive rule-out method compared to the current standard imaging, PSMA PET, which is expensive and involves radiation. The study is divided into four phases, including discovery, model development, internal validation, and external validation, to develop and test this RNA-based signatures accuracy and usefulness. The study includes a single group of 1000 men with suspected or confirmed prostate cancer who have not yet received treatment. Blood samples are taken before any treatment or biopsy to analyze exosomal RNA. The four phases include identifying RNA candidates through sequencing, developing a predictive model using digital PCR and machine learning, validating the model in a natural disease group, and externally validating it in a multi-center group. Bone metastasis is determined by PSMA PET scans. Participants will provide blood samples and may undergo prostate biopsy if needed. Researchers will assess the RNA tests performance by measuring sensitivity, specificity, predictive values, and correlation with imaging and clinical markers such as PSA levels and MRI findings. The study will also explore biological mechanisms and subgroup differences. Data confidentiality is maintained, and the study plans to run until 2027.

Plasma Exosomal RNA Signature for Prostate Cancer Bone Metastasis