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

Tethis

Status: Active, not recruiting

Conditions: Prostatic Neoplasms

Study type: Observational

Funder types: Industry

Identifiers

NCT04964271

TET-21-002

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 estimated patients

Sex: Male

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

60 participants in 3 patient groups

Low risk prostate cancer patients

Description:

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

Description:

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

Description:

Participants who are in good health and without history of cancer disease.