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NCT Number: NCT06762379

Implementation of a New Algorithm for HRR Gene Mutation Testing in Patients With mPC Through Liquid Biopsy Integration

Implementation of a new algorithm for HRR gene mutation testing in patients with mPC through liquid biopsy integration

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Key information

Conditions

Metastatic Prostate Cancer (mPC) Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

Male

Study type

Observational

Primary location

European Institute of oncology

Milan, Italy, 20141

Location status: Recruiting

Location contact

elena Guerini Rocco, MD

CONTACT

[email protected]

+300294372871

About this study

Analysis of the current clinical landscape of mPC Italy to identify gaps and opportunities for improvement.

Patient identification and enrollment Blood sample collection and plasma purification ctDNA extraction and NGS analysis of homologous recombination repair (HRR) genes. Clinical Real-World Data (RWD) and molecular analysis data collection Testing algorithm development based on collected data Finalization and sharing of a best practice model for diagnostic procedures in mPC patients

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients with metastatic prostate cancer whose tumor tissue is unavailable or inadequate for molecular testing. • Written informed consent must be signed and dated by the patient and the investigator prior to inclusion.

Exclusion criteria

  • Unable to provide written informed consent

Treatment and study plan

Primary outcomes

  1. Validation of an assay for homologous recombination repair (HRR) gene mutation testing using liquid biopsy

    Time frame: 3 years

    Validation of an assay for homologous recombination repair (HRR) gene mutation testing using liquid biopsy in patients with metastatic prostate cancer (mPC) whose tumor tissue is inadequate or unavailable for molecular testing.

Study contacts

Contact information is provided by the study sponsor or research team.

Elena Guerini Rocco, MD

CONTACT

[email protected]

00390294372871

francesca lombardi, biologist

CONTACT

[email protected]

00390257489425

Sponsors and collaborators

Lead sponsor

European Institute of Oncology

Other

Collaborators

  • Pfizer

Registry information

Official study title

Implementation of a New Algorithm for HRR Gene Mutation Testing in Patients With mPC

Acronym: L2-267

Important dates

Study start
2024
Primary completion
2027
Study completion
2030
First posted
Jan 7, 2025
Registry last updated
Mar 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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