Targeted Biopsies and the Role of Cytological Imprints for Diagnosis of Prostate Cancer
Background:
When substituting a random biopsy procedure with a few targeted biopsies, it is of outmost
importance to know immediately if the biopsy is positive or not. A recent study has
demonstrated a high sensitivity and specificity of imprint cytology of random biopsies.
Aim:
The correlation between cytological imprints and histology of targeted prostate biopsies
Material&Method:
All patients in this study are already participating in an ongoing randomized biopsy study
(NCT01455792) comparing:
1. Preoperative MRI and targeted biopsies + random biopsies .
2. Random biopsies (gold standard).
Only patients with a positive MRI were included in this collateral study.
The cytological imprints (negative/positive) of each targeted biopsy is compared to the
histology (negative/positive) and Gleason score.
Interventional
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
The rate of positive and negative cytological imprints, e.g presence of malignant cells or not.
The cytological imprints will be compared to the histology of targeted biopsies (defined as gold standard). Measure of agreement, sensitivity and specificity will be calculated.
15 months
No
Eduard Baco, MD
Principal Investigator
Oslo University Hospital
Norway:Local Regional Ethics Committee
OsloUH_2
NCT01745718
October 2012
December 2013
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