Know Cancer

or
forgot password

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


N/A
N/A
N/A
Open (Enrolling)
Male
Prostate Cancer

Thank you

Trial Information

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


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.


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

The rate of positive and negative cytological imprints, e.g presence of malignant cells or not.

Outcome 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.

Outcome Time Frame:

15 months

Safety Issue:

No

Principal Investigator

Eduard Baco, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Oslo University Hospital

Authority:

Norway:Local Regional Ethics Committee

Study ID:

OsloUH_2

NCT ID:

NCT01745718

Start Date:

October 2012

Completion Date:

December 2013

Related Keywords:

  • Prostate Cancer
  • prostate cancer
  • targeted biopsies
  • cytological imprints
  • histology
  • Prostatic Neoplasms

Name

Location