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

NCT02013180 | Completed Results

• 1 other identifier: Zinc/PSA
• Study Type: observational
• Target: 480
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostate Cancer Detection

Keywords

Prostate cancer, PSA, zinc, zinc/PSA

Outcome Measures

Primary Outcomes (1)

• Assesment of Serum Zinc/PSA Ratio in Patients With Prostate Cancer and Benign Prostatic Diseases

  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

Study Arms (2)

prostate cancer

prostate adenocarcinoma in pathologic evaluation

control

benign prostatic diseases in pathologic evaluation

Eligibility Criteria

• Sex: male
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bagcilar Training and Research Hospital: lead

Study Sites (1)

Bagcilar Training and Research Hospital-Depertmant of Urology

Istanbul, Bagcilar, 34100, Turkey (Türkiye)

Location

Related Publications (1)

• Temiz MZ, Cakir OO, Aykan S, Kucuk SH, Tiryakioglu NO, Bilek G, Tunali NE, Kandirali E, Semercioz A. The use of serum zinc to prostate-specific antigen ratio as a biomarker in the prediction of prostate biopsy outcomes. Biomark Med. 2019 Feb;13(2):59-68. doi: 10.2217/bmm-2018-0260. Epub 2019 Jan 23.

  PMID: 30672309 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

serum, prostatic tissue

MeSH Terms

Conditions

Prostatic Neoplasms; Salivary Gland Adenoma, Pleomorphic

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Results Point of Contact

• Title: Dr. Mustafa Zafer Temiz
• Organization: Catalca Ilyas Cokay State Hospital

dr_mustafazafertemiz@hotmail.com

+90 212 787 19 12

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: resident

Study Record Dates

• First Submitted: December 1, 2013
• First Posted: December 17, 2013
• Study Start: July 1, 2012
• Primary Completion: January 1, 2013
• Study Completion: January 1, 2017
• Last Updated: April 16, 2019
• Results First Posted: April 16, 2019

Record last verified: 2017-11

Locations

TU (1)