Actively Recruiting
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
Eligibility Criteria
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
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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Trial Site Locations
Total: 1 location
1
Uniklinikum Salzburg, Department for Urology and Andrology
Salzburg, State of Salzburg, Austria, 5020
Actively Recruiting
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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