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

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

NCT ID: NCT06579911

Condition: Prostatic Neoplasm of Uncertain Behavior

Conditions: Official terms:
Prostatic Neoplasms

Conditions: Keywords:
Prostate cancer
prostate biopsy
high frequency ultrasound
fusion biopsy
multiparametric mri of prostate
pirads
primus

Study type: Interventional

Study phase: N/A

Overall status: Recruiting

Study design:

Allocation: Randomized

Intervention model: Parallel Assignment

Intervention model description: Participants are randomly divided into two groups. One group (the experimental group) receives the combination of high-frequency micro-ultrasound, multiparametric MRI-targeted biopsy, and systematic biopsy. The other group (the control group) receives the current standard care, which includes only multiparametric MRI-targeted biopsy and systematic biopsy. This setup allows direct comparison of the detection rates of clinically significant prostate cancer between the new combination of interventions and the standard approach.

Primary purpose: Diagnostic

Masking: None (Open Label)

Intervention:

Intervention type: Device
Intervention name: High-frequency micro-ultrasound target biopsy
Description: 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
Arm group label: Group U

Intervention type: Device
Intervention name: conventional Multiparametric MRT target biopsy
Description: 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
Arm group label: Group S

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.

Detailed description: 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).

Criteria for eligibility:
Criteria:
Inclusion Criteria: - 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) Exclusion Criteria: - Patients with histopathologic proven prostate cancer - PSA > 20 ng/ml - Finding in digital rectal examination >= cT2c - Untreated bacterial infection of the prostate - Untreated coagulopathy

Gender: Male

Gender based: Yes

Minimum age: 18 Years

Maximum age: 99 Years

Healthy volunteers: Accepts Healthy Volunteers

Locations:

Facility:
Name: Uniklinikum Salzburg, Department for Urology and Andrology

Address:
City: Salzburg
Zip: 5020
Country: Austria

Status: Recruiting

Contact:
Last name: Lukas Lusuardi, Univ.Prof.Dr.

Phone: 0043 57255 27402
Email: l.lusuardi@salk.at

Start date: November 1, 2023

Completion date: January 1, 2026

Lead sponsor:
Agency: Salzburger Landeskliniken
Agency class: Other

Source: Salzburger Landeskliniken

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06579911