Clinical Study Evaluating Targeted Biopsies and Cytological Imprints in Prostate Cancer

Study Overview
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Brief Summary
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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
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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: 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.

Official Title
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Targeted Biopsies and the Role of Cytological Imprints for Diagnosis of Prostate Cancer

Conditions
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Prostate Cancer

Intervention / Treatment
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* Other: Cytological imprints


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: MRI and targeted biopsies<br>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<br>* Each targeted biopsy is subject to cytological imprints. It causes no extra biopsies or extra discomfort for the patients<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Interobserver variability | 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. | 15 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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prostate cancer, targeted biopsies, cytological imprints, histology