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

Not Applicable

Recruiting

• Conditions: Prostatic Neoplasm of Uncertain Behavior

• Registration Number: NCT06579911
• Lead Sponsor: Salzburger Landeskliniken

Brief 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).

Study Timeline

• Study Start: 2023-11-01
• Status Verified: 2024-08
• Study First Submitted: 2024-08-28
• Study First Submitted QC: 2024-08-28
• Study First Posted: 2024-08-30
• Last Update Submitted: 2024-08-30
• Last Update Posted: 2024-09-04
• Primary Completion: 2025-11-01
• Study Completion: 2026-01-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Male
• Target Recruitment: 400

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Detection of Clinically Significant Prostate Cancer via Prostate Biopsy	2 Weeks	This measure assesses whether participants have clinically significant prostate cancer (Gleason Score Sum ≥ ISUP 2) based on biopsy results, recorded as "yes" or "no".

Secondary Outcome Measures

Name	Time	Method
Detection of Clinically Insignificant Prostate Cancer via Prostate Biopsy	2 Weeks	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".