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

Prostate Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01915316
• Other study ID #: TP001
• Status: Completed
• Phase: N/A
• First received: July 30, 2013
• Last updated: October 27, 2015
• Start date: February 2014
• Est. completion date: February 2015

Study information

• Verified date: October 2015
• Source: ProSight
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: February 2015
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 45 Years and older

Eligibility

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

Observational Model: Cohort, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Prostate Cancer

Intervention

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

Locations

Country	Name	City	State
Israel	Tel Aviv Sourasky Medical Center	Tel Aviv

Sponsors (2)

Lead Sponsor	Collaborator
ProSight	Tel-Aviv Sourasky Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	No
Secondary	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	No