Fusion Versus Cognitive MRI Targeted Prostatic Biopsy

Study Overview
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Brief Summary
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The aim of the present study is to compare the accuracy of Magnetic resonance imaging targeted (fusion) versus cognitive prostatic biopsy in biopsy-naïve suspected cancer prostate patient

Detailed Description
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Prostate cancer is the second most frequent malignancy (after lung cancer) in men worldwide, counting 1,276,106 new cases and causing 358,989 deaths (3.8% of all deaths caused by cancer in men. The clinical prostate cancer detection rate of TRUS-guided needle biopsies is only 25-30%. while more than 50% of cancers that require definitive treatment remain undetected during initial biopsies . Clinical studies have shown that 75-80% of non-palpable carcinomas remain undetected during initial prostate biopsies. Multi-parametric prostate MRI has a high sensitivity for the detection of prostate adenocarcinoma and has shown promise for targeted biopsy of lesions that may be missed on routine systematic trans -rectal ultrasound (TRUS) biopsy . The most recent European Association of Urology guidelines recommend MRI before prostate biopsy for biopsy-naïve men with elevated PSA, the strength rating of the recommendation is weak. A systematic 12-core trans-rectal ultrasound-guided systematic biopsy (TRUS-SB) is still carried out for biopsy-naïve men at present. However, the TRUS-SB technique has several limitations, including over-diagnosis of clinically insignificant prostate cancer (CISCa), under-diagnosis of clinically significant prostate cancer (CSCa), false negative biopsy results and biopsy-related complications, such as bleeding and infections . Targeted prostate biopsies from MRI-suspicious lesions have been shown to improve the cancer detection rate (CDR) of CSCa compared with systematic TRUS-guided biopsies . Currently, three biopsy techniques are used for TB from MRI-suspicious lesions: in-bore MRI biopsies, cognitive magnetic resonance imaging trans-rectal ultrasound fusion targeted biopsy (COG-TB) and software guided magnetic resonance imaging-ultrasound fusion targeted biopsies (MRUS-TB). Inbore MRI biopsies that are carried out with an MRI-compatible guidance device can target suspicious lesions accurately; however, such biopsies are time-consuming and expensive . In the COG-TB technique, a physician samples a location that has been visually estimated using ultrasound and is considered to correspond to the location of a suspicious lesion that was detected on MRI. However, when the suspicious lesion is completely invisible (isoechoic or too small) on TRUS, the accuracy of such biopsies is likely reduced . The accuracy of COG-TB might be influenced by multiple factors, including the alignment of prostate landmarks, the physician's experience and so on. for these reasons, MRUS-TB where software fuses the MRI images with real-time TRUS images to guide the operator to biopsy the suspicious lesions is more commonly carried out; however, the optimal TB method remains unclear.

Official Title
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Magnetic Resonance Imaging Targeted (Fusion) Versus Cognitive Prostatic Biopsy in Biopsy-naïve Suspected Cancer Prostate Patient A Comparison Study

Conditions
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Prostatic Cancer

Intervention / Treatment
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* Procedure: MRI fusion targeted prostatic biopsy
* Procedure: MRI cognitive targeted prostatic biopsy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: prostate biopsy-naïve men PSA levels of up to 20 ng/mL Multi-parametric prostate MRI revealed a PIRAD 4 or PIRAD 5. Exclusion Criteria: PSA level greater than 20 ng/mL patient with history of TRUS biopsy patient diagnosed as cancer prostate or with distant metastasis
Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: fusion biopsy<br>This biopsy procedure that combines the pictures from an MRI and an ultrasound to create a detailed 3-D image of the prostate. This procedure makes it easier to see an abnormal area of prostate in order to guide the biopsy needle into the abnormal area. A sample of tissue can then be taken and checked under a microscope for cancer. A fusion biopsy may help find prostate cancer cells that may be missed with other types of biopsies. It may help find cancer at an early stage and plan cancer treatment. | Procedure: MRI fusion targeted prostatic biopsy<br>* combines the pictures from an MRI and an ultrasound to create a detailed 3-D image of the prostate. This procedure makes it easier to see an abnormal lesion of prostate in order to guide the biopsy needle into the abnormal lesion<br>* Other names: fusion biopsy;|
| Active Comparator: cognitive biopsy<br>the biopsy operator reviews the MR images and creates a mental three-dimensional representation of the prostate and of the lesion within it to take a biopsy from it | Procedure: MRI cognitive targeted prostatic biopsy<br>* the biopsy operator reviews the MR images and creates a mental three-dimensional representation of the prostate and of the lesion within it to take a biopsy from the lesion<br>* Other names: cognitive biposy;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| detection of clinically significant prostate cancer | accuracy of MRI targeted fusion versus cognitive prostatic biopsy in biopsy-naïve suspected cancer prostate patient to detect clinically significant prostate cancer | two weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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fusion biopsy