Clinical Study Evaluating Targeted Biopsies and Cytological Imprints in Prostate Cancer
The investigators will evaluate the accuracy of performing cytological imprints of targeted biopsies when diagnosing prostate cancer.
It is useful to know whether the biopsy is cancer or not, in order to know when to stop sampling and when to continue.
The strategy is used in other types of cancer, e.g lung, breast etc
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
|Official Title:||Targeted Biopsies and the Role of Cytological Imprints for Diagnosis of Prostate Cancer|
- The rate of positive and negative cytological imprints, e.g presence of malignant cells or not. [ Time Frame: 15 months ] [ Designated as safety issue: No ]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.
- Interobserver variability [ Time Frame: 15 months ] [ Designated as safety issue: No ]The cytological imprints will be evaluated by three different cytologists and classified as either negative or positive. The results will be compared to the histology which defines the gold standard. Any difference in evaluation will be assessed.
- The detection rate of high grade cancer [ Time Frame: 15 months ] [ Designated as safety issue: No ]The cytology will be compared to the specific Gleason score in patients with positive histology in order to evaluate any difference in the detection rate of intermediate/high grade cancer (Gleason score 7 or higher) and low grade cancer (<Gleason score 6).
|Study Start Date:||October 2012|
|Study Completion Date:||September 2013|
|Primary Completion Date:||August 2013 (Final data collection date for primary outcome measure)|
MRI and targeted biopsies
All patients receive the same level/number of diagnostic procedures. They all undergo targeted biopsies which are compared to the cytological imprints.
Other: Cytological imprints
Each targeted biopsy is subject to cytological imprints. It causes no extra biopsies or extra discomfort for the patients
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.
The correlation between cytological imprints and histology of targeted prostate biopsies
All patients in this study are already participating in an ongoing randomized biopsy study (NCT01455792) comparing:
- Preoperative MRI and targeted biopsies + random biopsies .
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01745718
|Oslo University Hospital , Aker|
|Oslo, Norway, 0514|
|Principal Investigator:||Eduard Baco, MD||Oslo University Hospital|