RecruitingNot ApplicableNCT03819751

MRI-targeted Biopsy of the Prostate: Software Versus Visual Registration in the Accuracy of Prostate Cancer Detection

MRI-targeted Biopsy of the Prostate: a Prospective Comparison of Software-based Fusion Versus Visual (Cognitive) Registration in the Accuracy of Clinically Significant Prostate Cancer Detection


Sponsor

Universitaire Ziekenhuizen KU Leuven

Enrollment

96 participants

Start Date

Mar 18, 2019

Study Type

INTERVENTIONAL

Conditions

Summary

With the general acceptance of MRI and technical advances in biopsy technique of the prostate, new questions arise concerning the selection of patients, the approach, the appropriate technique, the lesions to target and the number of biopsies. The purpose of this study is to address these issues in men suspicious of having prostate cancer and without prior biopsies.


Eligibility

Sex: MALEMin Age: 50 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This trial is comparing two methods of using MRI images to guide prostate biopsies — one using specialized computer software and one using a doctor's visual judgment — to see which approach more accurately finds prostate cancer. **You may be eligible if...** - You are a man between 50 and 75 years old - You have a clinical suspicion of prostate cancer (elevated PSA blood test or abnormal rectal exam) - Your prostate MRI has shown a suspicious area (rated PI-RADS 3 to 5) - You have not previously had a prostate biopsy or prostate cancer diagnosis - You are in generally good health **You may NOT be eligible if...** - You have already been diagnosed with prostate cancer - You have had a prostate biopsy before - You cannot have an MRI (for example, due to claustrophobia or certain metal implants) - Your MRI or CT scan shows cancer has spread to lymph nodes or bones - You have a hip replacement or pelvic metal implant that interferes with MRI 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

PROCEDUREMRI-targeted prostate biopsy

All participants receive traditional cognitive/visual registration biopsy and the above mentioned MRI/TRUS fusion biopsy (also known as software registration biopsy)


Locations(1)

UZ Leuven

Leuven, Vlaams-brabant, Belgium

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NCT03819751


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