Combining High-frequency Micro-ultrasound and Multiparametric MRI Target Biopsy for Detecting Prostate Cancer (Biopsy29)

August 30, 2024 updated by: Maximilian Pallauf, Salzburger Landeskliniken

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

**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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

400

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Salzburg, Austria, 5020
        • Recruiting
        • Uniklinikum Salzburg, Department for Urology and Andrology
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group U
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
  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
Active Comparator: Group S
Use of multiparametric MRI target biopsy and systematic biopsy (current standard of care) for tumor detection
Device: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Detection of Clinically Significant Prostate Cancer via Prostate Biopsy
Time Frame: 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".
2 Weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Detection of Clinically Insignificant Prostate Cancer via Prostate Biopsy
Time Frame: 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".
2 Weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Salzburger Landeskliniken

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2023

Primary Completion (Estimated)

November 1, 2025

Study Completion (Estimated)

January 1, 2026

Study Registration Dates

First Submitted

August 28, 2024

First Submitted That Met QC Criteria

August 28, 2024

First Posted (Actual)

August 30, 2024

Study Record Updates

Last Update Posted (Actual)

September 4, 2024

Last Update Submitted That Met QC Criteria

August 30, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Biopsy29

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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