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

Active, not recruiting

• Conditions: Prostatic Neoplasms

• Registration Number: NCT04964271
• Lead Sponsor: Tethis S.p.A.

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.

Study Timeline

• Study First Submitted: 2021-07-07
• Study First Submitted QC: 2021-07-07
• Study First Posted: 2021-07-16
• Study Start: 2021-09-09
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-17
• Last Update Posted: 2024-12-20
• Primary Completion: 2025-12
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Male
• Target Recruitment: 60

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Ospedale San Raffaele; 🇮🇹 Milano, Italy