Clinical Study Evaluating Targeted Biopsies and Cytological Imprints in Prostate Cancer
Status
Conditions
Treatments
Details and patient eligibility
About
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
Full 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:
- Preoperative MRI and targeted biopsies + random biopsies .
- 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.
Sex
Volunteers
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
Trial design
Primary purpose
Allocation
Interventional model
Masking
0 participants in 1 patient group
Trial contacts and locations
Loading...
Data sourced from clinicaltrials.gov
Clinical trials
Research sites
Resources
Legal