PRostate Evaluation for Clinically Important disease: Sampling using Image-guidance Or Not?
Completed
- Conditions
- Prostaatkanker detectieprostatecancer
- Registration Number
- NL-OMON42747
- Lead Sponsor
- Radboud Universitair Medisch Centrum
- Brief Summary
Trial is onging in other countries
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 17
Inclusion Criteria
Men at least 18 years of age regerred with clinical suspicion of prostate cancer who have been advised to have a prostate biopsy.
PSA * 20ng/ml within the previous 3 months
Suspected stage * T2 on rectal examination (organ-confined prostate cancer) within the previous 3 months
Exclusion Criteria
Prior prostate biopsy
Prior treatment for prostate cancer
Contrainidaction to MRI
Contraindication to prostate biopsy
evidence of untreated urinary tract infection
Previous hipreplacement surgery, metallic hip replacement
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Proportion of men with clinically significant cancer detected </p><br>
- Secondary Outcome Measures
Name Time Method <p>Proportion of men in MRI arm who avoid biopsy<br /><br>Proportion of men in whom MRI score for suspicion of clinically significant<br /><br>cancer was 3, 4 or 5 but no clinically significant cancer was detected<br /><br>Proportion of men who go on to definitive local treatment (e.g. radical<br /><br>prostatectomy, radiotherapy, brachytherapy) or systemic treatment (e.g. hormone<br /><br>therapy, chemotherapy)<br /><br><br /><br>Proportion Gleason grade upgrading in men undergoing radical prostatectomy<br /><br>Post-biopsy complications<br /><br>Health-realted quality of life</p><br>