New algorithm for gene testing in metastatic prostate cancer using liquid biopsy
Implementation of a New Algorithm for HRR Gene Mutation Testing in Patients With mPC
This study is trying out a new way to test for gene mutations in the blood of men with advanced prostate cancer to see if it can improve their diagnosis and treatment.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 125 (estimated) |
| Ages | 18 Years and up |
| Sex | Male |
| Sponsor | European Institute of Oncology Academic / other |
| Locations | 1 site (Milan, Italy) |
| Trial ID | NCT06762379 on ClinicalTrials.gov |
What this trial studies
This study focuses on implementing a novel algorithm for testing HRR gene mutations in patients with metastatic prostate cancer (mPC) by integrating liquid biopsy techniques. It involves analyzing the current clinical landscape in Italy to identify gaps in testing and treatment. The methodology includes patient enrollment, blood sample collection, plasma purification, ctDNA extraction, and next-generation sequencing (NGS) analysis of HRR genes. The goal is to develop a testing algorithm based on real-world data and molecular analysis, ultimately creating a best practice model for diagnostic procedures in mPC patients.
Who should consider this trial
Good fit: Ideal candidates for this study are patients with metastatic prostate cancer who do not have adequate tumor tissue available for molecular testing.
Not a fit: Patients who are able to provide adequate tumor tissue for molecular testing may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could enhance the accuracy of gene mutation testing in mPC patients, leading to more personalized treatment options.
How similar studies have performed: Other studies have shown promise in using liquid biopsy for genetic testing, but this specific algorithm implementation is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Milan, Italy
- European Institute of oncology — Milan, Italy, Italy (Recruiting)
Study contacts
- Study coordinator: Elena Guerini Rocco, MD
- Email: elena.guerinirocco@ieo.it
- Phone: 00390294372871
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.