Status:
COMPLETED
Biopsy Study Comparing MRI and Ultrasound Soft Image Fusion Guided Biopsies and Gold Standard Prostate Biopsies.
Lead Sponsor:
Oslo University Hospital
Conditions:
Prostate Cancer
Eligibility:
MALE
Phase:
NA
Brief Summary
Background: Prostate biopsies are usually performed due to accidentally discovered elevated prostate specific antigen (PSA) and/or abnormal digital rectal examination. Transrectal ultrasound (TRUS) gu...
Detailed Description
Biopsy procedures 1. Conventional TRUS biopsy procedure (Gold standard). These patients will first undergo 0-6 TRUS targeted biopsies (TRUS TB) (2 targeted biopsies in up to 3 lesions), directed towa...
Eligibility Criteria
Inclusion
- Inclusion criteria
- Patients without previous biopsies.
- Men aged \< 75 years, in whom it is clinically relevant to decide whether he has prostate cancer.
- PSA \> 3 - 4 ng/ml and \< 20 ng/ml.
- Suspicious findings on DRE or TRUS.
- Informed consent.
- Exclusion criteria
- Patients who refuse to sign the consent form for any reason or do not accept the study premises.
- Patients who want to withdraw for any reason during the study.
- Patients with contraindications to MRI (pacemaker, claustrophobia etc.)
- Patients who have already undergone a high quality MRI examination of the prostate within the last year. In this situation the MRI examination will be evaluated together with the surgeon and radiologist on an individual basis. In case of a low quality examination, we will disregard the findings, and include the patient.
- An accurate record will be kept of all the excluded patients.
Exclusion
Key Trial Info
Start Date :
September 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2013
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT01455792
Start Date
September 1 2011
End Date
September 1 2013
Last Update
December 30 2013
Active Locations (1)
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1
Oslo University Hospital, Aker
Oslo, Norway, 0514