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

Completed

• Conditions: Prostate Cancer
• Interventions: Other: prostate biopsy

• Registration Number: NCT01915316
• Lead Sponsor: ProSight

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-07-30
• Study First Submitted QC: 2013-07-31
• Study First Posted: 2013-08-02
• Study Start: 2014-02
• Primary Completion: 2014-12
• Study Completion: 2015-02
• Status Verified: 2015-10
• Last Update Submitted: 2015-10-27
• Last Update Posted: 2015-10-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 30

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Prostate cancer	prostate biopsy	Men. Subjects have undergone primary and at least one secondary prostate biopsy with negative diagnostics. Elevated PSA (Prostate Specific Antigen), typically above 10 ng/mL.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Tel Aviv Sourasky Medical Center; 🇮🇱 Tel Aviv, Israel