Biopsy Study Comparing MRI and Ultrasound Soft Image Fusion Guided Biopsies and Gold Standard Prostate Biopsies.

Launched by OSLO UNIVERSITY HOSPITAL · Oct 18, 2011

Keywords

ClinConnect Summary

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 towards lesions suspect of prostate cancer seen on TRUS, or detected by DRE (standard-target). Subsequently, they will undergo a standard random 12 core TRUS guided biopsy procedure. All biopsies will be performed using the Bruel and Kjaer ultrasound unit, type 1846, and transrectal transducer No 8531 (New york, United States). If there for any reason would be desirable to reduce the total number o...

Gender

MALE

Eligibility criteria

• • 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.