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

NCT01915316 | Completed

• 1 other identifier: TP001
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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

Study Arms (1)

Prostate cancer

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.

Other: prostate biopsy

Interventions

prostate biopsy OTHER

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

Prostate cancer

Eligibility Criteria

• Age: 45 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Men. Primary biopsy and at least one secondary (repeat) biopsy diagnosed negative. Elevated PSA, \>10ng/mL. Subject directed at saturated trans-perineal biopsy

You may qualify if:

• 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

You may not qualify if:

• Subject was under Zn supplement nutrition treatment

Sponsors & Collaborators

• ProSight: lead
• Tel-Aviv Sourasky Medical Center: collaborator

Study Sites (1)

Tel Aviv Sourasky Medical Center

Tel Aviv, 64239, Israel

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Haim Matzkin, Prof.

  Tel-Aviv Sourasky Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 30, 2013
• First Posted: August 2, 2013
• Study Start: February 1, 2014
• Primary Completion: December 1, 2014
• Study Completion: February 1, 2015
• Last Updated: October 29, 2015

Record last verified: 2015-10

Locations

IL (1)