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

Study Overview
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Brief Summary
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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.

Detailed Description
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Trial Design: This is a prospective, single center, comparative, diagnostic study of two biopsy techniques. All men aged 50 to 75 years with clinical suspicion of PCa (elevated prostate specific antigen (PSA) levels in blood and/or abnormal digital rectal examination) and an MRI with suspicious lesion(s) (presence of PI-RADS 3-5 lesion) will be included. Participants receive both types of biopsy, but will be randomized concerning the order of the biopsy. All men will also receive traditional systematic biopsies. Treatment and further follow-up is according to EAU guidelines. Data of treatment and follow-up will be retrieved till 2 years after initial MRI-visit. Sample Size: Based on McNemar test for the comparison between the accuracy of the two biopsy techniques, the required sample size is estimated on 96 patients. Assessment of efficacy: Efficacy of software and visual registration biopsy will be determined by histopathology: cancer core length (actual length and percentage) and comparison with systematic biopsy as reference standard. Direct access to source data and documents: The investigator(s) and the institution(s) will permit trial-related monitoring, audits, EC review, and regulatory inspections (where appropriate) by providing direct access to source data and other documents (i.e. patients' case sheets, blood test reports, X-ray reports, histology reports, etc.). Data handling and management: All data collected during the study remain confidential and according to the GDPR regulation. Data of the participants will be retrieved from their electronic patient files. Each participant will be given a unique identification number. When data are coded, there continues to be a link between the data and the individual who provided it. The research team is obligated to protect the data from disclosure outside the research according to the terms of the research protocol and the informed consent document. The subject's name or other identifiers should be stored separately (site file) from their research data and replaced with a unique code to create a new identity for the subject. Note that coded data are not anonymous. All data is collected and stored electronically by the principal investigator and co-investigators.

Official Title
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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

Conditions
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Prostate Cancer, Prostate Neoplasm

Intervention / Treatment
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* Procedure: MRI-targeted prostate biopsy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: willing to participate in the study by giving written informed consent. male subjects aged between 50 to 75 years. with a clinical suspicion of PCa: elevated prostate specific antigen (PSA) levels in blood and/or abnormal digital rectal examination (DRE). good health condition based on medical history, physical examination and vital sign measurements. with target lesion on dedicated MRI of the prostate (PI-RADS 3 to 5). Exclusion Criteria: has a prior history of prostate cancer. had prior prostate biopsy. has a contra-indication for MRI (claustrophobia, non-compatible metallic implants). has evidence of lymph nodes involvement on prostate MRI or abdominal CT has evidence of bone metastasis on bone scan. has a prior history of hip prosthesis, pelvic radiation therapy or androgen deprivation therapy unable to perform transrectal ultrasound due to prior rectal surgery or active rectal diseases (rectitis, …) has any condition, physical, mental, familial or sociological, that could impede compliance with the study protocol and further follow-up. This is not an absolute contra-indication, but should be discussed with patient prior to registration in the trial.

Ages Eligible for Study
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Minimum Age: 50 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: Diagnostic
Intervention Model: Single Group Assignment
Interventional Model Description: All patients receive both types of biopsy. Patients are randomized with one half having visual registration first and the other half having software registration first.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: MRI-targeted prostate biopsy<br>Participants receive both type of MRI-targeted biopsy. Patients are randomized with one half having visual registration first and the other half having software registration first. | Procedure: MRI-targeted prostate biopsy<br>* All participants receive traditional cognitive/visual registration biopsy and the above mentioned MRI/TRUS fusion biopsy (also known as software registration biopsy)<br>* Other names: MRI/TRUS fusion biopsy with Philips Percunav;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Accuracy of the two MR-guided registration techniques (visual and software-based) in the detection of clinically significant prostate cancer | Assessment of the detection rate of clinically significant prostate cancer of software registration biopsy and visual registration biopsy, using traditional TRUS-guided systematic biopsy, whole mount radical prostatectomy specimen and follow-up as reference. | From MRI-visit till results of radical prostatectomy is known or till up to 2 years after MRI-visit | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Analysis of the performance of software versus visual registration biopsy in subgroups | Assessment of the performance of software registration biopsy and visual registration biopsy in the detection of clinically significant cancer in : lesions in small volume prostates (<50 gram) versus large volume prostates (>50 gram). transitional zone versus peripheral zone lesions basal versus apical lesions small (max. diameter < or = 10 mm) versus large lesions (max. diameter > 10 mm) intermediate suspicious lesions (PI-RADS 3) versus highly suspicious lesions (PI-RADS 4-5). | From MRI-visit till results of radical prostatectomy is known or till up to 2 years after MRI-visit | 
| Added value of systematic biopsies | Assessment of the added value of systematic biopsies on top of MRI-targeted biopsy of PI-RADS 3, 4 and 5 lesions. Compare MRI-targeted + systematic biopsies versus MRI-targeted biopsies alone in T-staging and therapy options. | From MRI-visit till results of radical prostatectomy is known or till up to 2 years after MRI-visit | 
| Discriminative features of PI-RADS 3 lesions on MRI | Lesion diameters, shape, intensity on T2 and aspect, ADC-values on ADC-map will be measured to identify possible discriminative features of 'malignant' s benigne PI-RADS 3 lesions. | From MRI-visit till results of radical prostatectomy is known or till up to 2 years after MRI-visit | 
| Features of prostate cancer differentiation grade on MRI | Measure ADC-value to differentiate prostate cancer differentiation grade. | From MRI-visit till results of radical prostatectomy is known or till up to 2 years after MRI-visit | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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prostatic neoplasms, biopsy, Multimodal Imaging, prostate