RecruitingNot ApplicableNCT06579911

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

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

Sponsor

Salzburger Landeskliniken

Enrollment

400 participants

Start Date

Nov 1, 2023

Study Type

INTERVENTIONAL

Conditions

Prostatic Neoplasm of Uncertain Behavior

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.

Eligibility

Sex: MALEMin Age: 18 YearsMax Age: 99 Years

Plain Language Summary

Simplified for easier understanding

This study compares two imaging-guided biopsy methods for detecting clinically significant prostate cancer. One uses a high-frequency micro-ultrasound, and the other uses a multiparametric MRI scan. The goal is to see which approach — or combination — is more accurate at finding cancer that actually needs treatment. **You may be eligible if...** - You are a man with suspected prostate cancer based on a rising PSA level, an abnormal rectal exam, or both - Your MRI scan showed suspicious findings (PI-RADS score of 3 or higher) **You may NOT be eligible if...** - You have already been diagnosed with prostate cancer through a biopsy - You have a condition or implant that makes MRI unsafe for you Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEHigh-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

DEVICEconventional 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

Locations(1)

Uniklinikum Salzburg, Department for Urology and Andrology

Salzburg, State of Salzburg, Austria

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NCT06579911