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Clinical Study Evaluating Targeted Biopsies and Cytological Imprints in Prostate Cancer

This study is currently recruiting participants.
Verified December 2012 by Oslo University Hospital
Sponsor:
Information provided by (Responsible Party):
Oslo University Hospital
ClinicalTrials.gov Identifier:
NCT01745718
First received: November 20, 2012
Last updated: December 7, 2012
Last verified: December 2012
History of Changes
  Purpose

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


Condition Intervention
Prostate Cancer
 Other: Cytological imprints

Study Type: Interventional
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Oslo University Hospital:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Other Outcome Measures:
  • 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).


Estimated Enrollment: 100
Study Start Date: October 2012
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01745718

Contacts
Contact: Eduard Baco, MD 22894000 eduard.baco@oslo-HF.no
Contact: Erik Rud, MD 22894411 p.e.rud@medisin.uio.no

Locations
Norway
Oslo University Hospital , Aker Recruiting
Oslo, Norway, 0514
Contact: Eduard Baco, MD            
Contact: Erik Rud, MD            
Principal Investigator: Eduard Baco, MD            
Sponsors and Collaborators
Oslo University Hospital
Investigators
Principal Investigator: Eduard Baco, MD Oslo University Hospital
  More Information

No publications provided

Responsible Party: Oslo University Hospital
ClinicalTrials.gov Identifier: NCT01745718     History of Changes
Other Study ID Numbers: OsloUH_2
Study First Received: November 20, 2012
Last Updated: December 7, 2012
Health Authority: Norway:Local Regional Ethics Committee

Keywords provided by Oslo University Hospital:
prostate cancer
targeted biopsies
cytological imprints
histology

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
 Neoplasms
Genital Diseases, Male
Prostatic Diseases

ClinicalTrials.gov processed this record on May 19, 2013