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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02013180
Enrollment
480
Registered
2013-12-17
Start date
2012-07-31
Completion date
2017-01-31
Last updated
2019-04-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prostate Cancer Detection

Keywords

Prostate cancer, PSA, zinc, zinc/PSA

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.

Interventions

None listed

Sponsors

Bagcilar Training and Research Hospital
Lead SponsorOTHER_GOV

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
MALE
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Assesment of Serum Zinc/PSA Ratio in Patients With Prostate Cancer and Benign Prostatic Diseasesmeasurement of serum zinc and PSA levels are performed prior to transrectal prostat biopsy; pathologic evaluation of biopsy specimens are performed within 2-3 weeksDoes the zinc/PSA ratio show statistically signifacant difference in patients with prostate cancer?

Countries

Turkey (Türkiye)

Participant flow

Participants by arm

ArmCount
Prostate Cancer
prostate adenocarcinoma in pathologic evaluation
119
Control
benign prostatic diseases in pathologic evaluation
361
Total480

Baseline characteristics

CharacteristicControlTotalProstate Cancer
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
184 Participants265 Participants81 Participants
Age, Categorical
Between 18 and 65 years
177 Participants215 Participants38 Participants
Age, Continuous64.19 years
STANDARD_DEVIATION 7.53
65.23 years
STANDARD_DEVIATION 8.1
68.39 years
STANDARD_DEVIATION 9
Race and Ethnicity Not Collected0 Participants
Region of Enrollment
Turkey
361 participants480 participants119 participants
Sex: Female, Male
Female
0 Participants0 Participants0 Participants
Sex: Female, Male
Male
361 Participants480 Participants119 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 1190 / 361
other
Total, other adverse events
0 / 1190 / 361
serious
Total, serious adverse events
0 / 1190 / 361

Outcome results

Primary

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?

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

ArmMeasureValue (MEDIAN)
Prostate CancerAssesment of Serum Zinc/PSA Ratio in Patients With Prostate Cancer and Benign Prostatic Diseases150.8 ratio
ControlAssesment of Serum Zinc/PSA Ratio in Patients With Prostate Cancer and Benign Prostatic Diseases239.6 ratio

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026