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NCT Number: NCT06981377

PRostate Cancer Plasma Integrative Multi-modal Evaluation

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).

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Key information

Conditions

Metastatic Prostate Cancer Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

Male

Study type

Observational

Primary location

Istituto Romagnolo per lo Studio dei Tumori, Meldola, Forlì-Cesena, Italy

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Diagnostic Test

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.

Primary outcomes

  1. Quantification of circulating tumor DNA (ctDNA) in the plasma

    Time frame: From enrolment across different lines of treatment

    Number of circulating tumor DNA (ctDNA) in the plasma

  2. Quantification of the fraction of cfDNA hypo/hypermethylation

    Time frame: From enrolment across different lines of treatment

    Rate of cfDNA hypo/hypermethylation

  3. Presence of recurrent somatic aberrations in ctDNA (such as loss of RB1, TP53, BRCA1/2, or AR amplification).

    Time frame: From enrolment across different lines of treatment

    Assessment (yes/no) of recurrent somatic aberrations in ctDNA (such as loss of RB1, TP53,

  4. Presence of Copy Number Variants (CNVs) in ctDNA

    Time frame: From enrolment across different lines of treatment

    Assessment (yes/no) of Copy Number Variants (CNVs) in ctDNA

  5. Identification of EV-associated biomarkers

    Time frame: From enrolment across different lines of treatment

    Assessment (yes/no) of EV-associated biomarkers

Study contacts

Contact information is provided by the study sponsor or research team.

Orazio Caffo

CONTACT

[email protected]

+39 0461902121

Sponsors and collaborators

Lead sponsor

Santa Chiara Hospital

Other

Collaborators

  • Università degli Studi di Trento

Registry information

Official study title

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

Acronym: PRIME

Important dates

Study start
2019
Primary completion
2027
Study completion
2027
First posted
May 20, 2025
Registry last updated
May 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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