NCT06875297

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

A Comprehensive Cancer Genome Profiling to Detect Actionable Alteration Representative of Progression of Non-metastatic Prostate Cancer.

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 184 (estimated)
• Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS · Academic / Other
• Sex: Male
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The search for clinically actionable alterations within the non-metastatic prostate cancer setting has been an overlooked issue so far. Genomic alterations predicting tumor progression or representative of micrometastatic spread could be crucial to prompt the correct treatment strategy, sequencing and possible intensification in the high-risk and locally advanced settings. Similarly, the definition of the genomic landscape in low-risk patients progressing to more aggressive disease could be of importance to prompt an immediate active treatment to those patients otherwise eligible to active surveillance. A CGP program has been launched by the Fondazione Policlinico Universitario Agostino Gemelli IRCCS (FPG), a leading Italian research hospital (ID: FPG500, ethical approval number 3837) and it convers 10 cancer types. This program offers genomic testing of over 500 genes through an efficient in-house process. To now, a CGP from FPG 500 has been applied to cholangiocarcinoma, endometrial cancer, non-small cell lung cancer. Investigators propose a prospective interventional single center study whose aim is to implement a comprehensive genome profiling (CGP) through this next generation sequencing (NGS) program for non-metastatic PCa and to define actionable mutations that correlate with tumor progression. The actionability relies on the opportunity to intensify treatment in non metastatic cases at risk of progression or to identify distant spread before it becomes biochemically and/or radiographically evident for high risk non metastatic cancers. From previous research, a genomic profiling may reveal distinct mutations or gene expression patterns linked to metastasis, biochemical recurrence, and PSA persistence. Some of these genomics alterations may be associated with poorer outcomes in high-risk and locally advanced patients. Conversely, patients under active surveillance might exhibit a more stable genomic profile, with fewer mutations representative of aggressive disease. Expected outcomes will include the development of accurate prognostic tools, allowing for better-tailored treatment plans and early intervention strategies to manage disease progression.

Conditions

• Prostate Cancer

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2025-08-05
• Primary completion: 2027-10-08
• Completion: 2029-08-07
• First posted: 2025-03-13
• Last updated: 2025-03-21

Locations

1 site across 1 country: Italy