RecruitingNCT06981377

PRostate Cancer Plasma Integrative Multi-modal Evaluation

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

Sponsor

Santa Chiara Hospital

Enrollment

800 participants

Start Date

May 7, 2019

Study Type

OBSERVATIONAL

Conditions

Metastatic Prostate Cancer

Summary

The study aims to develop PRIME (PRostate cancer plasma Integrative Multi-modal Evaluation) liquid biopsy test and to implement its use to query prospectively collected samples in advanced prostate cancer (PCa) clinical trials and/or clinical settings. In order to maximise the utility of liquid biopsies for advanced PCa, PRIME is focused on the development of novel computational and sequencing approaches that integrate multiple information from plasma circulating elements: i) cell free DNA (cfDNA) gene mutation data with accurate quantitation of cfDNA structural genomic changes, ii) cfDNA genomic profiling with cfDNA methylation status, and iii) the information provided by extracellular vesicles (EVs) and EV-associated cargo (including DNA, RNA and proteins).

Eligibility

Sex: MALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is collecting blood samples (liquid biopsies) from men with prostate cancer who are about to start or change drug treatment. Researchers will analyze the blood to look for genetic and biological markers that could predict how well the treatment will work — helping doctors personalize treatment decisions in the future. **You may be eligible if...** - You have a confirmed prostate cancer diagnosis - You are eligible to start or change to a new pharmacological (drug-based) treatment for prostate cancer - You have given consent to participate **You may NOT be eligible if...** - Your cancer type is something other than prostate cancer Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DIAGNOSTIC_TESTAnalysis of cell free DNA, and extracellular vesicles (EVs) and EV-associated molecular components (including RNA, DNA, proteins)

Plasma and buffy coat samples are shipped from the recruiting clinical sites to the lab of Professor Francesca Demichelis at the University of Trento (UniTN). At UniTN, samples are stored in dedicated freezers with restricted access and subsequently used as follows: * the plasma is used for the isolation of cell free DNA and extracellular vesicles (EVs); * the buffy coat is used for the extraction of genomic DNA. Nucleic acids sequencing library preparations and all downstream omics analyses are performed by Prof. Demichelis team.