Zinc/PSA Ratio as a Novel Biomarker for Prostate Cancer Detection

January 15, 2019 updated by: Mustafa Zafer Temiz, Bagcilar Training and Research Hospital

Although Prostate Specific Antigen (PSA) is a useful marker for early detection of the prostate cancer, its specivity is not sufficient. Several PSA variations were defined in order to increase the specivity of the test, but they aren't much more effective than the PSA alone for detection of disease.

In older studies reported that, serum and prostatic tissue zinc levels decreased in prostat cancer disease.

In our study we aimed to establish the utility of serum zinc, PSA, free PSA/PSA (fPSA/tPSA), zinc/PSA, levels for early detection of the prostate cancer.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

480

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

  • Turkey
    • Bagcilar
      • Istanbul, Bagcilar, Turkey, 34100
        • Bagcilar Training and Research Hospital-Depertmant of urology

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Sampling Method

Non-Probability Sample

Study Population

patient with LUTS(lower urinary tract symptomps) and elevated serum PSA levels/suspicious rectal examination who undergone transrectal ultrasonography guided prostate biopsy

Description

Inclusion Criteria:

Patients with LUTS and elevated serum PSA levels and/or suspicious rectal examination

Exclusion Criteria:

usage of zinc included drugs, older prostatic operations, older prostatic radiotherapy, older prostatic biopsies, chronic rectal diseases (anal fissure, hemorrhoid, etc..), PIN(prostatic intraepithelial neoplasia) and ASAP(atypical small acinar proliferation) in pathologic evaluation.

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: Prospective

Cohorts and Interventions

Group / Cohort
prostate cancer
prostate adenocarcinoma in pathologic evaluation
control
benign prostatic diseases in pathologic evaluation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assesment of Serum Zinc/PSA Ratio in Patients With Prostate Cancer and Benign Prostatic Diseases
Time Frame: measurement of serum zinc and PSA levels are performed prior to transrectal prostat biopsy; pathologic evaluation of biopsy specimens are performed within 2-3 weeks
Does the zinc/PSA ratio show statistically signifacant difference in patients with prostate cancer?
measurement of serum zinc and PSA levels are performed prior to transrectal prostat biopsy; pathologic evaluation of biopsy specimens are performed within 2-3 weeks

Collaborators and Investigators

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

Sponsor

Bagcilar Training and Research Hospital

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

July 1, 2012

Primary Completion (Actual)

January 1, 2013

Study Completion (Actual)

January 1, 2017

Study Registration Dates

First Submitted

December 1, 2013

First Submitted That Met QC Criteria

December 11, 2013

First Posted (Estimate)

December 17, 2013

Study Record Updates

Last Update Posted (Actual)

April 16, 2019

Last Update Submitted That Met QC Criteria

January 15, 2019

Last Verified

November 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Zinc/PSA

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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