Clinical trial NCT06981377: PRostate Cancer Plasma Integrative Multi-modal Evaluation
Official title: Development of the PRIME Test for the Identification of Prostate Cancer Patients' Biomarkers Through Non-invasive Liquid Biopsies
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Metastatic Prostate Cancer
Keywords: Liquid biopsy
Cell free DNA (cfDNA)
Extracellular Vesicles (EVs)
Biomarkers
Lead sponsor: Santa Chiara Hospital
Sponsor class: OTHER
Collaborators: name: Università degli Studi di Trento
First posted: 2025-05-20
Enrollment: 800
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients are selected at oncology care clinics at participating clinical sites.

Brief 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 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

Primary outcomes:
measure: Quantification of circulating tumor DNA (ctDNA) in the plasma
timeFrame: From enrolment across different lines of treatment
measure: Quantification of the fraction of cfDNA hypo/hypermethylation
timeFrame: From enrolment across different lines of treatment
measure: Presence of recurrent somatic aberrations in ctDNA (such as loss of RB1, TP53, BRCA1/2, or AR amplification).
timeFrame: From enrolment across different lines of treatment
measure: Presence of Copy Number Variants (CNVs) in ctDNA
timeFrame: From enrolment across different lines of treatment
measure: Identification of EV-associated biomarkers
timeFrame: From enrolment across different lines of treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Meldola
country: Italy
facility: Istituto Romagnolo per lo Studio dei Tumori
state: Forlì-Cesena
city: Orbassano
country: Italy
facility: Azienda Ospedaliera San Luigi
state: Torino
city: Padova
country: Italy
facility: Istituto Oncologico Veneto
city: Trento
country: Italy
facility: Santa Chiara Hospital
Study officials:
References:
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