Measurements Of Zinc Concentration On Specimens Taken During Trans-Perineal Prostate Biopsy

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01915316

Enrollment

Registered

2013-08-02

Start date

2014-02-28

Completion date

2015-02-28

Last updated

2015-10-29

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

Conditions

Prostate Cancer

Brief summary

The purposes of this study are to: i) confirm and improve the accuracy of the correlation between levels of Zinc in prostate tissue and the grade of prostate cancer in that tissue as determined through pathology; and ii) determine the levels of zinc in prostate tissue declared as non-cancerous by pathology and located in the vicinity of tissue declared as cancerous by pathology, and verify that the Zinc levels for the declared non-cancerous tissue are lower (statistically significantly) than the levels for benign tissue not in the vicinity of cancerous tissue.

Interventions

OTHERprostate biopsy

Measurements of Zinc concentration along fresh Specimens taken during Trans-Perineal saturated repeat Prostate Biopsy before Specimens are sent to Pathology.

Study design

Observational model

COHORT

Time perspective

CROSS_SECTIONAL

Eligibility

Sex/Gender

MALE

Age

45 Years to No maximum

Healthy volunteers

Inclusion criteria

* Elevated PSA, \>10ng/mL * Subject underwent primary and at least one secondary (repeat) prostate biopsy with negative diagnosis * Subject directed at saturated trans-perineal biopsy

Exclusion criteria

* Subject was under Zn supplement nutrition treatment

Design outcomes

Primary

Measure	Time frame
Verify the existence of correlation between low levels of Zinc concentration in a biopsy specimen and the prostate cancer grade for that specimen determined by pathology.	Zinc measurements on biopsy specimens are performed during the biopsy session; pathology classification is typically performed within 2-4 weeks.

Secondary

Measure	Time frame
Verify that the levels of zinc in non-cancerous specimens located in the vicinity of a specimen declared as cancerous by pathology are lower (statistically significantly) than the levels for benign specimens not in the vicinity of the cancerous specimen.	Time frame for pathology: within 2-4 weeks

Countries

Israel

Outcome results

None listed

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