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

NCT ID: NCT06875297

Last Updated: 2025-03-21

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 184 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-08-05
• Study Completion Date: 2029-08-07

Brief 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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

FPG500 test

This is a single-center prospective interventional study involving patients with histologically confirmed low-risk, high-risk and locally advanced PCa.

A cancer genome profiling with FPG 500 will be performed within these cohorts. Samples will be available from surgery for high-risk and locally advanced PCa, from prostate biopsy for low risk patients.

Group Type: EXPERIMENTAL

FPG500

Intervention Type: DIAGNOSTIC_TEST

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.

Interventions

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.

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

Inclusion Criteria

• histologically proven diagnosis of low-risk, or high-risk or locally advanced prostate cancer
• high-risk and locally advanced prostate cancer undergoing surgery
• low-risk prostate cancer undergoing active surveillance or surgery

Exclusion Criteria

• previous or concomitant malignancies
• patients already undergoing androgen suppression or other medical treatments for prostate cancer

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

maria chiara

Role: PRINCIPAL_INVESTIGATOR

Fondazione

Locations

Fondazione Policlinico Universitario A. Gemelli IRCCS, UOC Urologia

Roma, , Italy

Countries

Italy

Central Contacts

Maria Chiara Sighinolfi

Role: CONTACT

mariachiara.sighinolfi@policlinicogemelli.it

0039 3921329216

Erika Mastrecchia

Role: CONTACT

erika.mastrecchia@policlinicogemelli.it

0039 3921329216

Facility Contacts

Maria Chiara C Sighinolfi, PhD

Role: primary

References

Sighinolfi MC, Pallotta G, Assumma S, Panio E, Pinto F, Gavi F, Totaro A, Presutti S, Pasciuto T, Nero C, Del Re M, Tagliaferri L, Ciccarese C, Iacovelli R, Gabarrini A, Patel E, Moschovas MC, Patel V, Rocco B. A novel comprehensive cancer genome profiling for non-metastatic prostate cancer: study protocol with FPG500 to detect actionable alterations representative of progressive disease. BJU Int. 2025 Oct 10. doi: 10.1111/bju.70019. Online ahead of print.

Reference Type: DERIVED

PMID: 41070807 (View on PubMed)

Other Identifiers

IDTBD

Identifier Type: -

Identifier Source: org_study_id