PRostate Cancer Plasma Integrative Multi-modal Evaluation (PRIME)

Santa Chiara Hospital

Status: Enrolling

Conditions: Metastatic Prostate Cancer

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

Study type: Observational

Funder types: Other

Identifiers

NCT06981377

PRIME - AA Trento

Details and patient eligibility

About

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).

Enrollment: 800 estimated patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

800 participants in 2 patient groups

Metastatic Castration Resistant Prostate Cancer (mCRPC) patients

Description:

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:

Diagnostic Test: 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

Description:

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:

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