Comparing pOrtable MRI and TRUS-Fusion Prostate Biopsy to Assess aCcuracy of Prostate Cancer Detection

Design: A single arm, singe centre study of 85 patients who have been selected to undergo prostate biopsy for suspected prostate cancer. Each patient would undergo both a portable MRI registered biopsy and the local standard ultrasound fusion biopsy. To reduce the risk of bias between the two types of biopsy the sequence will be randomised 1:1. There will be no blinding of the surgeon.

Patient Journey:

Patients eligible for the study will have already undergone a standard of care prostate MRI and offered a biopsy for any suspicious lesions seen. Eligible Patients will initially be contacted by a member of the study team and given written information on the study, After a period of time for the patient to review the information the patient will be contacted to give consent which can either be performed remotely or face-to-face.

After consent they will be asked to fill in questionnaires for baseline genito-urinary and bowel function using validated questionnaires and overall health status; this will be online or via paper copies. The questionnaires will consist of the HADS score questionnaire, EPIC (urinary, erectile, bowel) questionnaires and EuroQoL \[EQ-5D-5L\].

Patients who have consented to the study will then undergo a combined biopsy procedure either under local anaesthetic or if the patient wishes under sedation or general anaesthetic.

The current biopsy standard operating procedure (SOP) requires that 6 targeted cores per-lesion are taken along with 10-12 systematic cores of the remaining prostate. To ensure patient do not have cores taken in excess of the local SOP each enrolled patient will undergo transperineal prostate biopsy under local anaesthetic or sedation/general anaesthetic with a total of 6-targeted cores taken per lesion (three using each biopsy modality, ultrasound fusion or Portable MRI). All suspicious lesions will biopsied.

The patient will then be seen again in either in clinic (remote or face to face) to be given their biopsy results 2-12 weeks after the biopsy. The time point for this appointment will depend on the processing time of the biopsies by the pathology department as per the local standard of care clinical pathway. At this visit patients will be asked again to fill in questionnaires for baseline genito-urinary and bowel function using validated questionnaires and overall health status; this will be online or via paper copies. The questionnaires will consist of the HADS score questionnaire, EPIC (urinary, erectile, bowel) questionnaires and EuroQoL \[EQ-5D-5L\]. All the above visits mirror the local standard of care clinical pathway and except for the consent visit which could take place on the same day of the biopsy if the patient wishes there will be no additional burden of visits upon the patient.

There will be some optional consent points:

First, patients will also be asked to give optional consent for identifiable data to be linked with the national databases (ONS and HES database). Subsequent funding will be applied for from academic and charity funders to allow to carry out the linkage work. The identifiable fields (NHS number) required for linkage will be encrypted using a one-way encryption algorithm. Patients will be asked if they are happy to give consent for their health status to be followed up over time. This will be done by linking their name and NHS number with records held by the NHS and maintained by the NHS Information Centre and NHS Central Register or any applicable NHS information system.

This will allow to track what happens after the study finishes and observe if anyone gets cancer in future and about the type of cancer and treatment they have had. Patients will be asked whether or not they give permission to be contacted by member of the study research team within 10 years of signing their health status (including details of any other tests and treatment they have had since the study) and quality of life. If the patient decides to take part a member of the study research team may send this request to the patient's home address. The intention is to link individual trial informationto national databases on cancer diagnosis, GP databases on healthcare and medication use and finally death registry to see if any of the men died from prostate cancer.

As prostate cancer is often a slow-growing disease which may not progress for many years, patients will also be asked if they are happy to keep personal data stored or accessed for 10 years on the NHSCR (National Health Service Care Register). Second, in order to get an area based estimate of deprivation, the participants' partial postcodes will be converted into an Index of Multiple Deprivation (IMD) score. The IMD is the established index of deprivation for England and Wales and has been adopted widely in studies across local and national government. Partial postcodes will be stored in the study database, only IMD rank, which is based on detailed ward-level index of deprivation based on severe separate domains.

• Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 [Time frame: 2 years]
• Patient reported outcome measures (PROMS / HADS-D) of genitourinary health [Time frame: 2 years]
• Overall health-related quality of life as assessed by ICIQ-UI short form [Time frame: 2 years]
• Overall health-related quality of life as assessed by IPSS [Time frame: 2 years]
• Overall health-related quality of life as assessed by IPSS-QoL [Time frame: 2 years]
• Overall health-related quality of life as assessed by EQ5D [Time frame: 2 years]
• The sensitivity, specificity, and accuracy of using portable MRI to detect clinically significant prostate cancer [Time frame: 2 years]
• Concordance Rate of Prostate Cancer Detection between Portable MRI and Standard mpMRI [Time frame: 2 years]
• Patient reported outcome measures (PROMS / EPIC) of genitourinary health [Time frame: 2 years]
• Patient reported outcome measures (PROMS / EuroQol) of genitourinary health [Time frame: 2 years]