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OpenTrials
Active, Not Recruiting

NCT Number: NCT04964271

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Age range

18 year and older

Sex eligibility

Male

Study type

Observational

Primary location

Ospedale San Raffaele

Milan, 20132, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Tethis S.p.A.

Industry

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2026
Study completion
2026
First posted
Jul 16, 2021
Registry last updated
Feb 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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