Imaging for Significant Prostate Cancer Risk Evaluation

Study Overview
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Brief Summary
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The incidence of prostate cancer is rising however the number of deaths from prostate cancer is stable. Meaning the investigators are diagnosing many men with prostate cancer that will not impact on their life. The rise in incidence is mainly due to increased use of the blood test Prostate Specific Antigen (PSA), as a screening test. Currently men suspected of having prostate cancer, identified by a raised PSA undergo trans-rectal ultrasound guided prostate biopsy (TRUS biopsy). Many men have this test unnecessarily, only 1/3 being diagnosed with prostate cancer. TRUS biopsy is problematic as it is random and performed blind-the operator does not know where the cancer is. Thus many low-risk cancers that do not need treating are diagnosed and many high risk cancers are missed or incorrectly classified. So, men with a negative biopsy or those with low risk disease are usually advised to undergo another TRUS biopsy. An imaging test is needed that could help men and their doctors decide whether the biopsy is a true reflection of what is inside his prostate. The investigators will test the role of two imaging tests. The first, multi-parametric magnetic resonance imaging (mp-MRI) uses magnetic signals from the body to form images. The second, Prostate HistoScanning™ (PHS) uses sound-waves. The investigators will compare the results of these tests with a detailed biopsy map-transperineal template prostate mapping biopsy (which is currently the best way to find out what is in the prostate but requires multiple biopsies to be taken under general anaesthetic. Eligible men will have undergone one or more TRUS biopsies and who have been advised to have further tests on as part of standard of care. They will be recruited from UCLH referral letters and clinics. The investigators aim is to see if either of these tests can confidently rule out the presence of clinically important disease.

Official Title
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PICTURE - Prostate Imaging (Multi-parametric MRI and Prostate HistoScanning™) Compared to Transperineal Ultrasound Guided Biopsy for Significant Prostate Cancer Risk Evaluation.

Conditions
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Prostate Cancer

Intervention / Treatment
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* Procedure: Prostate HistoScanning
* Procedure: Multi-parametric MRI
* Procedure: Transperineal prostate mapping biopsy
* Procedure: Image guided biopsies


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Men who have undergone prior trans-rectal biopsies. Men undergoing further evaluation of their prostate and who are seeking characterisation using Transperineal Template Prostate Mapping Biopsy. Exclusion Criteria: Previous history of prostate cancer treatment Men unable to have MRI scan, or in whom artefact would reduce quality of MRI. Men unable to have general or regional anaesthesia Men unable to give informed consent

Ages Eligible for Study
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Minimum Age: 20 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
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Prostate HistoScanning|Advanced Ultrasound assessment of the prostate|
|Procedure: Multi-parametric MRI|Multi-sequence Magnetic resonance imaging of the prostate|
|Procedure: Transperineal prostate mapping biopsy|Needle biopsy of the perineum via the transperineal route at 5mm intervals guided by the use of ultrasound.|
|Procedure: Image guided biopsies|Biopsies targeted to lesions seen at a) Prostate HistoScanning and b) mp-MRI. In men with an MRI lesion further MRI/US registration biopsies will be obtained|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of men who could avoid repeat biopsy as determined by the Negative predictive value and specificity of mp-MRI for Clinically significant disease. | Performance characteristics of mp-MRI for ruling out CLINICALLY SIGNIFICANT prostate cancer as determined by negative predictive value and specificity | 18 months | 
| Number of men who could avoid repeat biopsy as determined by the negative predictive value and specificity of Prostate HistoScanning for Clinically significant disease. | Performance characteristics of Prostate HistoScanning for ruling out CLINICALLY SIGNIFICANT prostate cancer as determined by negative predictive value and specificity | 18 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of men correctly identified as having no cancer on Imaging (mp-MRI and Prostate HistoScanning) | Negative predictive value of Imaging compared to Transperineal template Mapping prostate biopsy. | 18 months | 
| Number of men correctly identified by Imaging (mp-MRI and Prostate HistoScanning) to have CLINICALLY SIGNIFICANT disease | Number of men correctly identified by each test to have clinically significant disease as detected by Transperineal Template Mapping Biopsy | 18 months | 
| Test- retest reproducibility of Prostate HistoScanning™. | The reproducibility of Prostate HistoScanning will be assessed by looking at the predicted cancer volume and location of the HistoScanning investigation at two time points. | 18 months | 
| Proportion of patients with correct disease risk stratification using MRI/US guided biopsies as determined by sensitivity and specificity | Performance characteristics of MRI/US registration targeted biopsies compared to i) systematic biopsies and ii) cognitive targeted biopsies in prostate cancer risk stratification as determined by sensitivity and specificity | 18 months | 
| Number of patients with bothersome Lower Urinary tract symptoms following Transperineal Template Mapping biopsy | Assessment of alterations in Lower Urinary tract function following Transperineal Template Mapping Biopsy IPSS, IPSS-QoL, Continence Function Questionnaire. | 18 months | 
| Number of patients with worsened erectile function compared to baseline following Transperineal Template Mapping biopsy | Assesment of erectile function compared to baseline will be made using questionnairres. IIEF | 18 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Prostate Cancer, Multi parametric MRI, Prostate HistoScanning, Transperineal prostate mapping biopsy