Identification of Prostate Cancer Specific Markers in Patients Compared to Healthy Participants

Identification and Characterization of Commercial RUO Antibodies for the Detection of Specific Prostate Cancer Tumoral Markers Expressed in Potential Circulating Tumoral Cells (CTCs)

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04964271

Enrollment

Registered

2021-07-16

Start date

2021-09-09

Completion date

2026-12-01

Last updated

2026-02-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prostatic Neoplasms

Keywords

prostate cancer biomarker, circulating tumoral cell, immunofluorescence assay, prostate cancer

Brief summary

This is an exploratory research study with the aim of identifying specific cancer biomarkers in various subtypes of prostate cancer. Blood samples will be collected from 60 participants divided into 40 patients and 20 healthy donors.

Detailed description

In this research study different commercial RUO (Research Use Only) antibodies will be purchased and then tested on blood samples obtained by patients affected by prostate cancer and by healthy participants as control. Sixty participants will be enrolled belonging to different risk categories:20 participants affected by prostate cancer at low risk, 20 participants affected by prostate cancer at high risk, and 20 participants without a cancer disease (healthy volunteers) as control. Risk categorization is based on the definition of the European Association of Urology. After signing the informed consent form, participants will be screened to evaluate if they meet the eligibility criteria. If all the criteria are met, participants will be enrolled into the study and will be asked to provide some demographic and other data. A 13 ml blood sample will be collected by the participants and shipped to Sponsor's laboratories, in order to be processed and analysed.

Interventions

None listed

Study design

Observational model

CASE_CONTROL

Time perspective

CROSS_SECTIONAL

Eligibility

Sex/Gender

MALE

Age

18 Years to No maximum

Healthy volunteers

Yes

Inclusion criteria

* Participant is willing and able to give and sign a written informed consent for participation in the study * Male, aged 18 years or above * Diagnosed with prostate cancer at low or high risk * Candidate to active surveillance (in case of low-risk disease) or treatment with curative intent such as radical prostatectomy or radiation therapy (in case of low risk patients not willing to undergo active surveillance or patients with high risk disease) * Healthy participants undergoing a visit at the site for reason other than cancer diagnosis (including prostate cancer)

Exclusion criteria

* History of other malignancies other than prostate cancer (for healthy participants includes also prostate cancer) * Undergone surgery or treatment for prostate cancer before enrolment * Presence of known severe coagulation or haematological disorder * Absence of written signed informed consent for participation in the study

Design outcomes

Primary

Measure	Time frame	Description
Number of commercial Antibodies capable of identify specific Prostate Cancer Biomarkers	day 1 : blood collection day	Qualitative assessment of Staining Positivity for different Prostate Cancer Biomarkers

Countries

Italy

Contacts

PRINCIPAL_INVESTIGATORAlberto Briganti, MD

Ospedale San Raffaele

Outcome results