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Clinical Study Evaluating Targeted Biopsies and Cytological Imprints in Prostate Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01745718
Recruitment Status : Withdrawn (The study was stopped for technical reasons)
First Posted : December 10, 2012
Last Update Posted : September 23, 2015
Information provided by (Responsible Party):
Oslo University Hospital

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

Condition or disease Intervention/treatment Phase
Prostate Cancer Other: Cytological imprints Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Targeted Biopsies and the Role of Cytological Imprints for Diagnosis of Prostate Cancer
Study Start Date : October 2012
Actual Primary Completion Date : August 2013
Actual Study Completion Date : September 2013

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. The rate of positive and negative cytological imprints, e.g presence of malignant cells or not. [ Time Frame: 15 months ]
    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 :
  1. Interobserver variability [ Time Frame: 15 months ]
    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:
  1. The detection rate of high grade cancer [ Time Frame: 15 months ]
    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).

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01745718

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Oslo University Hospital , Aker
Oslo, Norway, 0514
Sponsors and Collaborators
Oslo University Hospital
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Principal Investigator: Eduard Baco, MD Oslo University Hospital
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Responsible Party: Oslo University Hospital Identifier: NCT01745718    
Other Study ID Numbers: OsloUH_2
First Posted: December 10, 2012    Key Record Dates
Last Update Posted: September 23, 2015
Last Verified: September 2015
Keywords provided by Oslo University Hospital:
prostate cancer
targeted biopsies
cytological imprints
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Prostatic Diseases