Clinical trial Recruiting at 4 sites Observational Ages 18 and up Men only

Developing a liquid biopsy test for advanced prostate cancer

Official title: Development of the PRIME Test for the Identification of Prostate Cancer Patients' Biomarkers Through Non-invasive Liquid Biopsies

Run by Santa Chiara Hospital · NCT06981377 · Data updated 2026-11-12

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 typeObservational
Ages18 Years and up
SexMen only
Enrollment800 (estimated)
SponsorSanta Chiara Hospital
Academic / other
Locations4 sites (Meldola, Forlì-Cesena and 3 other locations)
StatusRecruiting
StartedMay 7, 2019
Main results expectedJanuary 31, 2027
Study endsJanuary 31, 2027
Registry record updatedMay 20, 2025
Trial IDNCT06981377 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates for this study are patients diagnosed with prostate cancer who are eligible for pharmacological treatment.

Probably not a fit

Patients with histological diagnoses other than prostate cancer will not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

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 gone: Other studies utilizing liquid biopsies and cfDNA analysis have shown promise in cancer diagnostics, suggesting that this approach may yield beneficial results.

Who can join: the full rules

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 it's running

  • 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.