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Combining High-frequency Micro-ultrasound and Multiparametric MRI Target Biopsy for Detecting Prostate Cancer
Sponsor: Salzburger Landeskliniken
Summary
\*\*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.
Official title: Combining High-frequency Micro-ultrasound Target Biopsy and Multiparametric MRI Target Biopsy - Does It Increase the Detection Rate of Clinically Significant Prostate Cancer? a Prospective, Interventional, Single Centre, Randomized Controlled Trial
Key Details
Gender
MALE
Age Range
18 Years - 99 Years
Study Type
INTERVENTIONAL
Enrollment
400
Start Date
2023-11-01
Completion Date
2026-01-01
Last Updated
2024-09-04
Healthy Volunteers
Yes
Conditions
Interventions
High-frequency micro-ultrasound target biopsy
1. High-frequency micro-ultrasound (transrectal ultrasound, 29 Hz, ExactVu) of the prostate. If suspicious lesions (PRIMUS \>= 3) other than those already detected in multiparametric MRI are found, target biopsy will be performed. Maximum of four cores per lesion. 2. Multiparametric MRI target biopsy (PI-RADS \>= 3) of the prostate (transrectal ultrasound, 29 Hz, ExactVu). Maximum of four cores per lesion. 3. Systematic biopsy (twelve cores) of the prostate
conventional Multiparametric MRT target biopsy
1. Multiparametric MRT target biopsy (PI-RADS \>= 3) of the prostate (conventional transrectal ultrasound, 8-10 Hz). Maximum of four cores per lesion. 2. Systematic biopsy (twelve cores) of the prostate
Locations (1)
Uniklinikum Salzburg, Department for Urology and Andrology
Salzburg, Salzburg, Austria