Measurements Of Zinc Concentration On Specimens Taken During Trans-Perineal Prostate Biopsy
Completed
- Conditions
- Prostate Cancer
- 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
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
- 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
Tel Aviv Sourasky Medical Center🇮🇱Tel Aviv, Israel