Clinical Study Evaluating Targeted Biopsies and Cytological Imprints in Prostate Cancer
- Conditions
- Prostate Cancer
- Registration Number
- NCT01745718
- Lead Sponsor
- 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
- 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.
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- Male
- Target Recruitment
- Not specified
- Prostate specific antigene (PSA) 4-20ng/ml, and/or abnormal digital rectal examination
- No previous prostate biopsies
- Positive MRI
- Signed letter of informed concent
- Contraindications to MRI
- Previous prostate biopsies
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method The rate of positive and negative cytological imprints, e.g presence of malignant cells or not. 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
Name Time Method Interobserver variability 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.
Trial Locations
- Locations (1)
Oslo University Hospital , Aker
🇳🇴Oslo, Norway
Oslo University Hospital , Aker🇳🇴Oslo, Norway