Implementation of a New Algorithm for HRR Gene Mutation Testing in Patients With mPC Through Liquid Biopsy Integration (L2-267)

March 23, 2026 updated by: European Institute of Oncology

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

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

Study Overview

Status

Recruiting

Conditions

Detailed Description

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

Study Type

Observational

Enrollment (Estimated)

125

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Italy
    • Italy
      • Milan, Italy, Italy, 20141
        • Recruiting
        • European Institute of Oncology
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients with metastatic prostate cancer

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
patient with metastatic prostate cancer (mPC)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

European Institute of Oncology

Collaborators

Pfizer

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 20, 2024

Primary Completion (Estimated)

December 31, 2027

Study Completion (Estimated)

December 31, 2030

Study Registration Dates

First Submitted

December 31, 2024

First Submitted That Met QC Criteria

January 6, 2025

First Posted (Actual)

January 7, 2025

Study Record Updates

Last Update Posted (Actual)

March 24, 2026

Last Update Submitted That Met QC Criteria

March 23, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • L2-267

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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