Clinical Study Evaluating Targeted Biopsies and Cytological Imprints in Prostate Cancer

This study has been withdrawn prior to enrollment.
(The study was stopped for technical reasons)
Information provided by (Responsible Party):
Oslo University Hospital Identifier:
First received: November 20, 2012
Last updated: September 22, 2015
Last verified: September 2015

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:

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).

Enrollment: 0
Study Start Date: October 2012
Study Completion Date: September 2013
Primary Completion Date: August 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:


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.


The correlation between cytological imprints and histology of targeted prostate biopsies


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.


Genders Eligible for Study:   Male
Accepts 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01745718

Oslo University Hospital , Aker
Oslo, Norway, 0514
Sponsors and Collaborators
Oslo University Hospital
Principal Investigator: Eduard Baco, MD Oslo University Hospital
  More Information

No publications provided

Responsible Party: Oslo University Hospital Identifier: NCT01745718     History of Changes
Other Study ID Numbers: OsloUH_2
Study First Received: November 20, 2012
Last Updated: September 22, 2015
Health Authority: Norway:Local Regional Ethics Committee

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

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Diseases, Male
Genital Neoplasms, Male
Neoplasms by Site
Prostatic Diseases
Urogenital Neoplasms processed this record on November 27, 2015