Combining High-frequency Micro-ultrasound and Multiparametric MRI Target Biopsy for Detecting Prostate Cancer

  • 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

info icon 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)

info icon Minimum age: 18

info icon Patients with histopathologic proven prostate cancer

info icon PSA \> 20 ng/ml

info icon Finding in digital rectal examination \>= cT2c

info icon Untreated bacterial infection of the prostate

info icon 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

NCT06579911

Clinic Location Investigator Distance RECRUITING STATUS Contact