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

January 29, 2026 updated by: Tethis S.p.A.

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

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.

Study Overview

Status

Active, not recruiting

Conditions

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.

Study Type

Observational

Enrollment (Estimated)

60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Milan, Italy, 20132
        • Ospedale San Raffaele

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Probability Sample

Study Population

Participants will be selected from among the people who visit the urology department

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Cross-Sectional

Cohorts and Interventions

Group / Cohort
Low risk prostate cancer patients
Prostate cancer risk category is based on the definition of the European Association of Urology, namely low risk (PSA (prostate-specific antigen) <10 ng/ml, and stage T1/T2a and Gleason score 3+3).
High risk prostate cancer patients
Prostate cancer risk category is based on the definition of the European Association of Urology, namely high risk (PSA (prostate-specific antigen) >20 ng/ml or stage T3 or higher or biopsy Gleason score 8-10).
Healthy donor
Participants who are in good health and without history of cancer disease.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tethis S.p.A.

Investigators

  • Principal Investigator: Alberto Briganti, MD, Ospedale San Raffaele

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 9, 2021

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

July 7, 2021

First Submitted That Met QC Criteria

July 7, 2021

First Posted (Actual)

July 16, 2021

Study Record Updates

Last Update Posted (Actual)

February 2, 2026

Last Update Submitted That Met QC Criteria

January 29, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TET-21-002

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

This is a basic research study without an IPD information sharing plan

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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