A Single-center Prospective Interventional Study on FPG500 in Non-metastatic Prostate Cancer Patients

NANot yet recruitingINTERVENTIONAL
Enrollment

184

Participants

Timeline

Start Date

August 5, 2025

Primary Completion Date

October 8, 2027

Study Completion Date

August 7, 2029

Conditions
Prostate Cancer
Interventions
DIAGNOSTIC_TEST

FPG500

A cancer genome profiling with FPG500 will be performed on samples available from surgery or biopsy. Specimen are reviewed to assess tumor cell fraction. All H\&E slides are digitized before nucleic acid extraction. Semi-automated process is used for DNA/RNA extraction, DNA fragmentation, quantification, library preparation, and sequencing. Profiling is done with the TruSight Oncology 500 assay, analyzing 523 genes for single nucleotide variants, insertions/deletions, copy number variations, and fusions/splicing variants in 55 genes. It also evaluates genomic signatures like microsatellite instability and tumor mutational burden. Sequencing data are processed using Illumina software and a custom pipeline. Post-sequencing quality control is performed. Variants are classified according to the Human Genome Variation Society and clinical actionability guidelines. Genomic report is reviewed by an institutional Molecular Tumor Board.

Trial Locations (1)

00168

Fondazione Policlinico Universitario A. Gemelli IRCCS, UOC Urologia, Roma

All Listed Sponsors
lead

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

OTHER