Clinical Study Evaluating Targeted Biopsies and Cytological Imprints in Prostate Cancer

Prostate Cancer Clinical Trial

Official title:

Targeted Biopsies and the Role of Cytological Imprints for Diagnosis of Prostate Cancer

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01745718
• Other study ID #: OsloUH_2
• Status: Withdrawn
• Phase: N/A
• First received: November 20, 2012
• Last updated: September 22, 2015
• Start date: October 2012
• Est. completion date: September 2013

Study information

• Verified date: September 2015
• Source: Oslo University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Norway:Local Regional Ethics Committee
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: September 2013
• Est. primary completion date: August 2013
• Accepts healthy volunteers: No
• Gender: Male
• Age group: N/A and older

Eligibility

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

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

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

Locations

Country	Name	City	State
Norway	Oslo University Hospital , Aker	Oslo

Sponsors (1)

Lead Sponsor	Collaborator
Oslo University Hospital

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	The detection rate of high grade cancer	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 (	15 months	No
Primary	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.	15 months	No
Secondary	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.	15 months	No