Prostate Cancer
Conditions
Keywords
prostate cancer, targeted biopsies, cytological imprints, histology
Brief summary
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
Detailed description
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.
Interventions
OTHERCytological imprints
Each targeted biopsy is subject to cytological imprints. It causes no extra biopsies or extra discomfort for the patients
Sponsors
Oslo University Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
MALE
Healthy volunteers
No
Inclusion criteria
* Prostate specific antigene (PSA) 4-20ng/ml, and/or abnormal digital rectal examination * No previous prostate biopsies * Positive MRI * Signed letter of informed concent
Exclusion criteria
* Contraindications to MRI * Previous prostate biopsies
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The rate of positive and negative cytological imprints, e.g presence of malignant cells or not. | 15 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Interobserver variability | 15 months | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| The detection rate of high grade cancer | 15 months | 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). |
Countries
Norway
Outcome results
None listed