Measurements Of Zinc Concentration On Specimens Taken During Trans-Perineal Prostate Biopsy
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| 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
Measurements of Zinc concentration along fresh Specimens taken during Trans-Perineal saturated repeat Prostate Biopsy before Specimens are sent to Pathology.
|
Outcome Measures
Primary Outcome Measures
- 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
- 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]
Eligibility Criteria
Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Tel Aviv Sourasky Medical Center | Tel Aviv | Israel | 64239 |
Sponsors and Collaborators
- ProSight
- Tel-Aviv Sourasky Medical Center
Investigators
- Principal Investigator: Haim Matzkin, Prof., Tel-Aviv Sourasky Medical Center
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- TP001