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

Completed

• Conditions: Prostate Cancer Detection

• Registration Number: NCT02013180
• Lead Sponsor: Bagcilar Training and Research Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-07
• Primary Completion: 2013-01
• Study First Submitted: 2013-12-01
• Study First Submitted QC: 2013-12-11
• Study First Posted: 2013-12-17
• Study Completion: 2017-01
• Status Verified: 2017-11
• Results First Submitted: 2017-11-27
• Results First Submitted QC: 2019-01-15
• Last Update Submitted: 2019-01-15
• Results First Posted: 2019-04-16
• Last Update Posted: 2019-04-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 480

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Assesment of Serum Zinc/PSA Ratio in Patients With Prostate Cancer and Benign Prostatic Diseases	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?

Trial Locations

Locations (1)

Bagcilar Training and Research Hospital-Depertmant of Urology; 🇹🇷 Istanbul, Bagcilar, Turkey