Blood Test Study for Advanced Prostate Cancer Patients
Develops a blood test to analyze DNA and vesicles in adults with metastatic prostate cancer.
Key facts
- Who runs it
- Santa Chiara Hospital
- Where
- Meldola, Orbassano, Padova, and Trento, ItalySee the 4 sites
- Trial code
- Registry title
- PRostate Cancer Plasma Integrative Multi-modal Evaluation
- Status
- Recruiting
- People taking part
- 800 people, planned
- Started
- 7 May 2019
- Expected to end
- 31 Jan 2027
- Type of study
- Observational, 2 groups
- Treatments tested
- Analysis of cell free DNA, and extracellular vesicles (EVs) and EV-associated molecular components (including RNA, DNA, proteins)
- Record updated
- 20 May 2025
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for men with prostate cancer who can start drug treatment. Blood samples are used to develop a liquid biopsy test called PRIME.
- Age
- 18 years or older
- Sex
- Men only
- Disease stage
- Prostate cancer; the record names metastatic prostate cancer as the condition.
Main reasons for not taking part
- Cancer of another type than prostate cancer, shown by tissue examination
The registry criteria, word for word
Show all 4 criteriaShow less
Who can take part
- Diagnosis of prostate cancer
- Eligible for prostate cancer pharmacological treatment
- Given consent to study participation
Who cannot take part
- Histological diagnosis other than prostate cancer
Where in Italy
- Istituto Romagnolo per lo Studio dei TumoriMeldola, ItalyContact: Ugo De Giorgi, MD, PhDTaking people
- Azienda Ospedaliera San LuigiOrbassano, ItalyContact: Consuelo Buttigliero, MD, PhDTaking people
- Istituto Oncologico VenetoPadova, ItalyContact: Umberto Basso, MDTaking people
- Santa Chiara HospitalTrento, ItalyContact: Orazio Caffo, MDTaking people
About the trial
What the trial wants to find out
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).
The 2 groups in the trial
- Metastatic Castration Resistant Prostate Cancer (mCRPC) patients
This group includes mCRPC patients treated with serial lines of treatment. For each line of treatment, blood samples are collected: 1. Before starting the treatment; 2. After 12 weeks; 3. At the end of the treatment/progression.
Treatment: Analysis of cell free DNA, and extracellular vesicles (EVs) and EV-associated molecular components (including RNA, DNA, proteins)
- Metastatic Hormon Sensitive Prostate Cancer (mHSPC) patients
This group includes mHSPC patients treated with hormone therapy. In the hormone sensitive setting, blood samples are collected: 1. Before starting the treatment; 2. After 12 weeks; 3. Every six months until progression to the castration resistant status.
Treatment: Analysis of cell free DNA, and extracellular vesicles (EVs) and EV-associated molecular components (including RNA, DNA, proteins)
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Development of the PRIME Test for the Identification of Prostate Cancer Patients' Biomarkers Through Non-invasive Liquid Biopsies
- Plain-language title
- Blood Test Study for Advanced Prostate Cancer PatientsGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Record updated
- 20 May 2025