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

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.

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Key information

Conditions

Prostate Cancer Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

45 year and older

Sex eligibility

Male

Study type

Observational

Primary location

Tel Aviv Sourasky Medical Center

Tel Aviv, 64239, Israel

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

prostate biopsy

Other

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

Primary outcomes

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.

Time frame: Zinc measurements on biopsy specimens are performed during the biopsy session; pathology classification is typically performed within 2-4 weeks.

Secondary outcomes

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: Time frame for pathology: within 2-4 weeks

Sponsors and collaborators

Lead sponsor

ProSight

Industry

Collaborators

Tel-Aviv Sourasky Medical Center

Registry information

Important dates

Study start: 2014
Primary completion: 2014
Study completion: 2015
First posted: Aug 2, 2013
Registry last updated: Oct 29, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed