An interventional study of High-frequency micro-ultrasound target biopsy and conventional Multiparametric MRT target biopsy in Prostatic Neoplasm of Uncertain Behavior, sponsored by Salzburger Landeskliniken. Recruiting at 1 site in Austria. Open to male participants aged 18 Years to 99 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-06-09.
Sponsored by Salzburger Landeskliniken · Not applicable, Interventional, and Diagnostic
**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:**
**Participation in the Study:**
Participants in this study will undergo the following procedures:
**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:**
The primary objective of this study is (i) to demonstrate that the combination of highfrequency micro-ultrasound target biopsy, multiparametric MRI target biopsy, and systematic biopsy detects more clinically significant prostate cancer (>= ISUP 2) than multiparametric MRI target biopsy and systematic biopsy alone (current standard of care).
The secondary objective of this study is (ii) to demonstrate that the combination of high frequency micro-ultrasound target biopsy, multiparametric MRI target biopsy, and systematic biopsy does not detect more clinically insignificant prostate cancer (ISUP 1) than multiparametric MRI target biopsy and systematic biopsy alone (current standard of care).
The third objective of this study is (iii) to demonstrate that the combination of highfrequency micro-ultrasound target biopsy and multiparametric MRI target biopsy does not detect less clinically significant prostate cancer (>= ISUP 2) than multiparametric MRI target biopsy and systematic biopsy (current standard of care).
The fourth objective of this study is (iv) to demonstrate that the combination of highfrequency micro-ultrasound target biopsy and multiparametric MRI target biopsy detects less clinically insignificant prostate cancer (ISUP 1) than the combination of multiparametric MRI target biopsy and systematic biopsy (current standard of care).
7,046 studies on the registry are indexed under Prostatic Neoplasms; 1,580 are open to participants now.
This study's planned enrollment of 400 is above the median of 60 across 5,348 interventional studies indexed under Prostatic Neoplasms.
Browse Prostatic Neoplasms studies →Salzburger Landeskliniken is the lead sponsor of 15 studies on the registry; 4 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
- Men with suspected 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)
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Use of high-frequency micro-ultrasound target biopsy, multiparametric MRI target biopsy and systematic biopsy for tumor detection
Device: High-frequency micro-ultrasound target biopsy
Use of multiparametric MRI target biopsy and systematic biopsy (current standard of care) for tumor detection
Device: conventional Multiparametric MRT 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
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
Detection of Clinically Significant Prostate Cancer via Prostate Biopsy
This measure assesses whether participants have clinically significant prostate cancer (Gleason Score Sum ≥ ISUP 2) based on biopsy results, recorded as "yes" or "no".
Time frame: 2 Weeks
Detection of Clinically Insignificant Prostate Cancer via Prostate Biopsy
This measure evaluates whether participants have clinically insignificant prostate cancer (Gleason Score Sum = ISUP 1) based on biopsy results, also recorded as "yes" or "no".
Time frame: 2 Weeks
Plan to share: No — No individual participant data (IPD) will be shared with other researchers. The data collected from participants will remain confidential and will be used exclusively for the analysis and reporting within the confines of this study. This approach ensures the privacy and security of participant information.
Started Nov 2023 (actual). Primary completion is estimated for Nov 2027, 48 months after the start.
Of 1,098 non-industry interventional studies with no phase under Prostatic Neoplasms, half reached primary completion within 43 months of starting (the median), counting those still running; a quarter within 22 and three quarters within 86. This study's planned 48 months is above that.
Counting every sponsor, half of 1,155 studies reached it within 43 months; a quarter within 22 and three quarters within 84.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
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Salzburger Landeskliniken