- Recruiting
- Diagnostic
- Interventional
- Randomized
- Device
- Salzburger Landeskliniken
- 18 - 99 Years
Study Purpose
\*\*Study Goal:\*\* The purpose of this clinical trial is to determine if combining high-frequency micro-ultrasound with multiparametric MRI biopsy and a systematic biopsy can better detect clinically significant prostate cancer compared to current standard methods. This study is aimed at men who may have prostate cancer. \*\*Main Questions the Study Aims to Answer:\*\* 1. Does the combination of new biopsy methods detect more clinically significant prostate cancers than the current standard method? 2. Does the new method not increase the detection of less serious forms of cancer beyond what the standard method detects? \*\*Participation in the Study:\*\* Participants in this study will undergo the following procedures: * A high-frequency micro-ultrasound examination of the prostate. * A multiparametric MRI-targeted biopsy of the prostate. * A systematic biopsy of the prostate. \*\*Comparison Group:\*\* Researchers will compare the new combination method with the current standard method to see if the new approach is more effective. \*\*Participants will:\*\* * Undergo several exams and biopsies depending on the results of previous tests. * Attend regular follow-up appointments to monitor potential side effects and evaluate prostate health. * Record their experiences and any symptoms in a diary.
Intervention
Device : High-frequency micro-ultrasound target biopsy
Device : conventional Multiparametric MRT target biopsy
Eligibility Requirements
Men with suspected clinically significant prostate cancer, identified by the rise in PSA level, suspicious digital rectal examination or both and pathologic multiparametric MRI of the prostate (\>= PI-RADS III)
Minimum age: 18
Patients with histopathologic proven prostate cancer
PSA \> 20 ng/ml
Finding in digital rectal examination \>= cT2c
Untreated bacterial infection of the prostate
Untreated coagulopathy
Recruiting status
Recruiting
Estimated enrollment
400
Study start date
Nov 01, 2023
Study end date
Jan 01, 2026
Last updated
Mar 23, 2025
Primary purpose
Diagnostic
Design
Interventional
Intervention
Device
Study phase
NA
Allocation
Randomized
Sponsor:
Salzburger Landeskliniken
Collaborator:
N/A
Investigator:
N/A
Publications
Websites
N/A
NCT06579911
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