Comparison of transperineal MRI/Ultrasound-fusion biopsy oft he prostate to transrectal ultrasound guided biopsy with elastography, color sonography and contrast enhanced ultrasound in the detection of prostate cancer in men with prior negative prostate biopsy
Not Applicable
Recruiting
- Conditions
- C61Malignant neoplasm of prostate
- Registration Number
- DRKS00009407
- Lead Sponsor
- Klinik und Poliklinik für UrologieUniversitätsklinikum Carl Gustav Carus
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Male
- Target Recruitment
- 240
Inclusion Criteria
Age > 40, = 75 years;
-PSA > 3,0ng/ml;
-At least one prior negative prostate biopsy,
-no contraindications for mpMRI
-no contraindications for the application of ultrasound contrast agent (SonoVue; Fa. Bracco)
-signed consent form
Exclusion Criteria
Known prostate cancer
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Proportion of men diagnosed with clinically significant cancers defined by Gleason Score = 3+4=7 by all biopsy methods (MRI/ultrasound-fusion biopsies vs. standard biopsies alone and in combination with targeted biopsy in multiparametric ultrasonography).
- Secondary Outcome Measures
Name Time Method -proportion of men with diagnosed prostate cancer with a Gleason Score >= 6 in MRI/Ultrasound-fusion biopsy vs. Targeted biopsy in multiparametric ultrasonography vs. Systematic biopsy<br>-overall detection rate in all three methods<br>-proportion of prostate cancer (Gleason Score >=6 and >= 3+4) in MRI lesions with PIRADS >=3<br>-proportion of positive cores in all three methods overall and separately<br>-proportion of positive cores with clinically significant cancer in all three methods<br>-proportion of lesions in mpMRI with PIRADS>=2 without tumour detection<br>-proportion of lesions in multiparametric ultrasonography with and without tumour detetction<br>-detection of prostate cancer Gleason score >=6 in multiparametric ultrasonography<br>-correlation of stiffness and ratio of stiffness in elastography with tumour detection rate and tumour aggressivenenss<br>-correlation of the grade of perfusion in doppler ultrasound and contrast enhanced ultrasound<br>