Developing a liquid biopsy test for advanced prostate cancer
Development of the PRIME Test for the Identification of Prostate Cancer Patients' Biomarkers Through Non-invasive Liquid Biopsies
This study is testing a new blood test for advanced prostate cancer to see if it can help doctors make better treatment decisions by analyzing different genetic information.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 800 (estimated) |
| Ages | 18 Years and up |
| Sex | Male |
| Sponsor | Santa Chiara Hospital Academic / other |
| Locations | 4 sites (Meldola, Forlì-Cesena and 3 other locations) |
| Trial ID | NCT06981377 on ClinicalTrials.gov |
What this trial studies
This study focuses on creating the PRIME liquid biopsy test to analyze plasma samples from patients with metastatic prostate cancer. It aims to integrate various data types, including cell free DNA (cfDNA) mutations, structural genomic changes, and extracellular vesicle (EV) information. By employing advanced computational and sequencing techniques, the study seeks to enhance the diagnostic utility of liquid biopsies in clinical settings and trials for advanced prostate cancer. The goal is to provide a comprehensive evaluation of biomarkers that could inform treatment decisions.
Who should consider this trial
Good fit: Ideal candidates for this study are patients diagnosed with prostate cancer who are eligible for pharmacological treatment.
Not a fit: Patients with histological diagnoses other than prostate cancer will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more accurate and personalized treatment options for patients with metastatic prostate cancer.
How similar studies have performed: Other studies utilizing liquid biopsies and cfDNA analysis have shown promise in cancer diagnostics, suggesting that this approach may yield beneficial results.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Diagnosis of prostate cancer * Eligible for prostate cancer pharmacological treatment * Given consent to study participation Exclusion Criteria: \- Histological diagnosis other than prostate cancer
Where this trial is running
Meldola, Forlì-Cesena and 3 other locations
- Istituto Romagnolo per lo Studio dei Tumori — Meldola, Forlì-Cesena, Italy (Recruiting)
- Azienda Ospedaliera San Luigi — Orbassano, Torino, Italy (Recruiting)
- Istituto Oncologico Veneto — Padova, Italy (Recruiting)
- Santa Chiara Hospital — Trento, Italy (Recruiting)
Study contacts
- Study coordinator: Orazio Caffo
- Email: orazio.caffo@apss.tn.it
- Phone: +39 0461902121
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.