C61 R77.80
Conditions
Interventions
Group 1: All men:
mp-MRI (T2, DCE, DWI), with PI-RADS scoring AND conventional systematic ultrasound guided biopsy (12 cores) performed by an experienced urologist.
Group 2: Depending on mp-MRI:
PI-RA
Sponsors
Universitätsklinikum Heidelberg
Eligibility
Sex/Gender
Male
Age
40 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Men referred for an initial prostate biopsy; 2. PSA > 3.0 and <50 ng/ml; 3. No contraindications to mp-MRI.
Exclusion criteria
Exclusion criteria: 1. Prior prostate biopsy; 2. Highly suspicious prostate nodule on DRE; 3. Contraindications to prostate biopsy; 4. Known prostate cancer.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of men diagnosed with significant cancers defined by Gleason score =7 disease by the two methods (MRI-targeted biopsies vs. standard biopsies). | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Proportion of men diagnosed with clinically insignificant prostate cancer (MRI-targeted biopsies vs. standard biopsies). 2. Proportion of men diagnosed with significant cancers defined by Gleason score =7 disease in MRI-targeted biopsies in men with PI-RADS sum =9 vs. the rest. 3. Overall cancer detection rates of MRI-targeted biopsies vs. MRI-targeted biospies in combination with standard biopsies. 4. Proportion of positive cores with any cancer (number of cores with cancer / number of cores taken). 5. Proportion of positive cores with clinically important cancer (number of cores with cancer / number of cores taken). 6. Number of cases where MRI shows definitive lesions but biopsy shows no cancer or Gleason score 6 cancer (false positive rate). 7. Location and size of tumors detected by either sampling strategy or both. | — |
Countries
Germany
Contacts
Public ContactBoris Hadaschik
Urologische Universitätsklinik Heidelberg
Outcome results
None listed