Advanced Magnetic Resonance Imaging (MRI) in Men With Suspected Prostate Cancer

Study Overview
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Brief Summary
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The clinical trial aims to address the critical challenge of differentiating aggressive from indolent prostate cancers by correlating prospectively collected MultiParametric (MP) Magnetic Resonance Imaging (MRI) data (index test) with the histopathology of radical prostatectomy specimens (reference standard). The study design incorporates pre-biopsy MRI, routine standard of care Transrectal Ultrasound guided (TRUS) biopsies and MRI/Ultrasound (US) image fusion techniques to guide biopsies to the suspicious areas identified by MRI. The hypothesis is that MP-MRI will allow pre-treatment determination of prostate cancer aggressiveness and MRI/US image fusion is expected to accurately co-locate cancer foci within the prostate gland for guiding biopsies. Pre-treatment prediction of Gleason grade as a marker of cancer aggressiveness will better inform clinicians and patients to improve risk stratification and facilitate decision making on subsequent treatment. Image fusion will allow accurate targeting of the most suspicious areas on MP-MRI for biopsy, which could obviate the need for multiple biopsies.

Detailed Description
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There is preliminary evidence suggesting that MultiParametric Magnetic Resonance Imaging (MP-MRI) can be a marker for prostate cancer (PCa) aggressiveness and could be used to plan treatment. Gleason grade (GG) is a critical predictor of the aggressiveness of PCa, but in up to one in three men, the histology of radical prostatectomy specimens is different from the histology of Transrectal Ultrasound (TRUS)-guided biopsies. This discrepancy contributes to- and is a sign of- poor risk stratification of men with localised PCa. The research aims to answer the following questions: Can image-fusion techniques allow investigators to reliably target abnormal areas seen on MP-MRI? How reliable is pre-biopsy MP-MRI in correctly predicting aggressive disease? The investigators envisage that MP-MRI information will reduce unnecessary biopsies and over-detection of indolent PCa, while improving the detection of aggressive disease. Primary Objectives • To determine whether using MP-MRI can improve cancer detection and characterization of prostate cancer Secondary Objectives • To determine whether US/MRI FUSION guided biopsy can reduce the number of false negative biopsies.

Official Title
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Multiparametric Magnetic Resonance Imaging Characterization and Guided Biopsy of the Prostate in Men Suspected of Having Prostate Cancer

Conditions
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Prostate Cancer

Intervention / Treatment
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* Procedure: TRUS Biopsy
* Procedure: TRUS/FUSION Biopsy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Males between the age of 40-75 at referral With at least 10 years life expectancy With clinically localised PCa: Prostate Specific Antigen (PSA) ≤20 ng/ml And/or abnormal Digital Rectal Examination (DRE) but < T3 disease Ability to informed consent Exclusion Criteria: Unable to give informed consent Prior prostatic biopsy within 12 months Contraindications to biopsy Poor general health and life expectancy < 10 years Previous diagnosis of acute prostatitis within 12 months History of prostate cancer Prior transurethral prostatectomy Contraindications to MRI (cardiac pacemakers, allergic reaction to gadolinium based contrast, renal function with baseline eGRF 30 ml/min, intracranial clips, claustrophobia) Previous hip replacement

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 75 Years

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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: TRUS Biopsy<br>Standard of Care Treatment | Procedure: TRUS Biopsy<br>* Standard of Care Treatment<br>|
| Other: TRUS/FUSION Biopsy<br>Interventional Treatment | Procedure: TRUS/FUSION Biopsy<br>* Interventional Treatment<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of prostate cancers detected by MP-MRI when compared to gold standard prostatectomy specimen | Number of prostate cancers detected by MP-MRI when compared to gold standard | 5 years from first recruitment | 
| Number of clinically significant cancers detected by MP-MRI when compared to gold standard prostatectomy specimen | The definition of clinically significant disease will be based on the pathologic assessment of radical prostatectomy (RP) specimen and will include the presence of any the following three prognostic factors: o Gleason grade >= 7 with pattern 4 or/and 5 Maximum cancer focus size more than 6mm measured in the axial plane Presence of extracapsular extension (ECE) | 5 years from first recruitment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of cancer detected in each randomised group, namely intervention group (TRUS/FUSION biopsy) versus standard of care (TRUS biopsy) | Number of cancer detected in each randomised group | 5 years from first recruitment | 
| Number of significant cancer detected in each randomised group, namely intervention group (TRUS/FUSION biopsy) versus standard of care (TRUS biopsy) | Number of significant cancer detected in each randomised group | 5 years from first recruitment | 
| Safety outcomes(death, post biopsy pain, bleeding, sepsis and hospitalization) of intervention (biopsy) in each of the two randomised groups. | Number of participants with deaths, side effects (post biopsy pain, bleeding, sepsis and hospitalization) in each of the two randomised groups. | 4 years from first recruitment | 
| Comparison of MRI negative standard of care TRUS guided biopsies with MRI positive TRUS histopathology to facilitate analysis of diagnostic accuracy of MRI in men suspected with target condition. | Comparison of MRI negative standard of care TRUS guided biopsies with MRI positive TRUS histopathology | 5 years from first recruitment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Image-guided biopsy, Tumour detection, Diagnostic, Biomarkers