Clinical Study Evaluating Targeted Biopsies and Cytological Imprints in Prostate Cancer

Oslo University Hospital

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Conditions

Prostate Cancer

Interventions

Cytological imprintsOTHER

Each targeted biopsy is subject to cytological imprints. It causes no extra biopsies or extra discomfort for the patients

Eligibility

Sex: MALE

Medical Language ↔ Plain English

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

Locations (1)

Oslo University Hospital , Aker

Oslo, Norway

Outcomes

Primary Outcomes

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.

Time frame: 15 months

Secondary Outcomes

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.

Time frame: 15 months

Data from ClinicalTrials.gov

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