C61
Conditions
Interventions
Group 1: In study arm 1, a perineal targeted tissue biopsy is performed under local anesthesia from the index lesion identified as suspicious on bpMRI, with three biopsies of the suspicious area. Only
Sponsors
Klinik und Poliklinik für urologie und Kinderurologie der Universitätsklinik Bonn
Eligibility
Sex/Gender
Male
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Biparametric magnetic resonance imaging performed at the University Hospital Bonn to ensure uniform quality standards. Adequate image quality with imaging performed in accordance with version 2.1 of the Prostate Imaging Reporting and Data System and a Prostate Imaging Quality score of at least 2 out of 3. The patient provides written informed consent to participate in the study. Patients who are able to follow study instructions and are likely to attend all required study visits (compliance).
Exclusion criteria
Exclusion criteria: The patient has a prostate-specific antigen level greater than 25 ng/ml with suspicion of primarily metastatic prostate cancer.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Detection rate of clinically significant prostate cancers (defined as prostate cancer with an ISUP = 2), obtained through a single intervention (the biopsy). | — |
Secondary
| Measure | Time frame |
|---|---|
| Peri-interventional pain in both arms using the numerical rating scale (NRS) from 0 to 10 Sensitivity and specificity of digital rectal examination (DRE), transrectal ultrasound (TRUS), PSA level, PSA density, and PIRADS Upstaging of the ISUP grade/Gleason score in the patient subgroup undergoing subsequent radical prostatectomy in the two randomized study arms Detection rate of secondary tumor foci of clinically significant tumors >5 mm or Gleason 4 in >10% of the biopsy core outside the penumbra (defined as a 1 cm² area around the target lesion) Peri-interventional complication rate (urinary tract infection, gross hematuria, urinary retention) in both arms after biopsy, comparing the frequencies of predefined adverse events (Grade 3: Severe or medically significant but not immediately life-threatening; hospitalization or prolongation) of hospitalization. indicated; disabling; limiting self-care ADL.) of the two study arms in relation to the total number of biopsies and in relation to anticoagulants. | — |
Countries
Germany
Contacts
Public ContactPhilipp Krausewitz
Klinik und Poliklinik für Urologie und Kinderurologie der Universitätsklinik Bonn
Outcome results
None listed