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

NCT06579911 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 400

Last updated 2024-09-04

No results posted yet for this study

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.

Conditions

  • Prostatic Neoplasm of Uncertain Behavior

Interventions

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

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

Sponsors & Collaborators

  • Salzburger Landeskliniken

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-11-01
Primary Completion
2025-11-01
Completion
2026-01-01

Countries

  • Austria

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06579911 on ClinicalTrials.gov