Actively Recruiting

Phase Not Applicable
Age: 18Years - 99Years
MALE
Healthy Volunteers
NCT06579911

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

Led by Salzburger Landeskliniken · Updated on 2024-09-04

400

Participants Needed

1

Research Sites

113 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

\*\*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

Official Title

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

Who Can Participate

Age: 18Years - 99Years
MALE
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Men with suspected clinically significant prostate cancer based on rising PSA, suspicious digital rectal exam, or both
  • Multiparametric MRI of the prostate showing lesions scored PI-RADS 3 or higher
Not Eligible

You will not qualify if you...

  • History of confirmed prostate cancer
  • PSA level greater than 20 ng/ml
  • Digital rectal exam finding equal to or greater than cT2c
  • Untreated bacterial infection of the prostate
  • Untreated blood clotting disorder

AI-Screening

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Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Uniklinikum Salzburg, Department for Urology and Andrology

Salzburg, State of Salzburg, Austria, 5020

Actively Recruiting

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How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

DIAGNOSTIC

Number of Arms

2

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