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Clinical Study Evaluating Targeted Biopsies and Cytological Imprints in Prostate Cancer

Primary Purpose

Prostate Cancer

Status
Withdrawn
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Cytological imprints
Sponsored by
Oslo University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Prostate Cancer focused on measuring prostate cancer, targeted biopsies, cytological imprints, histology

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • Oslo University Hospital , Aker

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

MRI and targeted biopsies

Arm Description

All patients receive the same level/number of diagnostic procedures. They all undergo targeted biopsies which are compared to the cytological imprints.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
November 20, 2012
Last Updated
September 22, 2015
Sponsor
Oslo University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01745718
Brief Title
Clinical Study Evaluating Targeted Biopsies and Cytological Imprints in Prostate Cancer
Official Title
Targeted Biopsies and the Role of Cytological Imprints for Diagnosis of Prostate Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
September 2015
Overall Recruitment Status
Withdrawn
Why Stopped
The study was stopped for technical reasons
Study Start Date
October 2012 (undefined)
Primary Completion Date
August 2013 (Actual)
Study Completion Date
September 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Oslo University Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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: 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
prostate cancer, targeted biopsies, cytological imprints, histology

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
MRI and targeted biopsies
Arm Type
Other
Arm Description
All patients receive the same level/number of diagnostic procedures. They all undergo targeted biopsies which are compared to the cytological imprints.
Intervention Type
Other
Intervention Name(s)
Cytological imprints
Intervention Description
Each targeted biopsy is subject to cytological imprints. It causes no extra biopsies or extra discomfort for the patients
Primary Outcome Measure Information:
Title
The rate of positive and negative cytological imprints, e.g presence of malignant cells or not.
Description
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 Outcome Measure Information:
Title
Interobserver variability
Description
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
Other Pre-specified Outcome Measures:
Title
The detection rate of high grade cancer
Description
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).
Time Frame
15 months

10. Eligibility

Sex
Male
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eduard Baco, MD
Organizational Affiliation
Oslo University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Oslo University Hospital , Aker
City
Oslo
ZIP/Postal Code
0514
Country
Norway

12. IPD Sharing Statement

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Clinical Study Evaluating Targeted Biopsies and Cytological Imprints in Prostate Cancer

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