The added value of MRI for detection of prostate cancer: validation with MR guided biopsies, fusion of MRI and transrectal ultrasound guided biopsies and TRUS guided biopsies.
Recruiting
- Conditions
- prostate cancerprostate carcinoma10038594
- Registration Number
- NL-OMON32545
- Lead Sponsor
- niversitair Medisch Centrum Sint Radboud
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 60
Inclusion Criteria
• PSA>=4.0 ng/ml
• One or more previous negative TRUS guided prostate biopsies
Exclusion Criteria
• Patients with known contradictions to MRI
• Patients with known contra-indications to Gadolinium based contrast agents.
• Patients with previous radiotherapy, hormonal therapy or local treatment of the prostate.
• Patients with histological prove of prostate cancer
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Detection rates of MRGB (expected to be over 27%) compared to a second or later<br /><br>TRUSGB (expected to be 17% or less). Detection rate of MRUSFGB.</p><br>
- Secondary Outcome Measures
Name Time Method <p>Percentage of patients upgraded by MRGB and MRUSFGB respectively compared to<br /><br>TRUSGB.<br /><br>The mean increase of Gleason score for MRGB and MRUSFGB respectively compared<br /><br>to TRUSGB.<br /><br>Predicitive accuracy for MRGB, MRUSFGB and TRUSGB Gleason score for true<br /><br>prostatectomy specimen Gleason score in case of prostatectomy.<br /><br>The increase of detection of clinical significant prostate cancers by MRGB and<br /><br>MRUSFGB in comparison to TRUSGB. </p><br>