Clinical trial NCT06453785: Comparing pOrtable MRI and TRUS-Fusion Prostate Biopsy to Assess aCcuracy of Prostate Cancer Detection
Official title: Comparing pOrtable MRI and TRUS-Fusion Prostate Biopsy to Assess aCcuracy of Prostate Cancer Detection
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Prostate Cancer
Keywords: biopsy
MRI
Lead sponsor: Imperial College London
Sponsor class: OTHER
First posted: 2024-06-12
Enrollment: 85
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Currently, patients suspected of having prostate cancer undergo an MRI followed by targeted biopsies of any suspicious lesions under trans-rectal ultrasound (TRUS) guidance. This pathway is labour, time, and cost-intensive. Additionally, TRUS-MRI-Fusion devices are needed, which overlay the MRI scan onto the TRUS used for biopsies. This can lead to targeting errors due to mismatched images. Although biopsies can be performed in the MRI scanner to reduce these errors, it requires a significant amount of time within an expensive MRI scanner in the radiology department, along with special MRI-compatible equipment. Portable MRI technology has the potential to reduce these errors and streamline the diagnostic pathway to one visit. The Promaxo portable MRI is an FDA-cleared MRI device for MR-guided procedures. It uses a novel "truly" open MRI with an unobstructed field of view and a central aperture for robotic-guided intervention and has a limited footprint, allowing it to be placed in a standard operating theatre or large clinic room. The strength of the magnet is also low enough that special precautions and equipment are not needed to take biopsies.

The intention is to conduct a study that answers the following research question: How does the accuracy of targeted biopsies of the prostate performed under the guidance of a portable MRI scanner compare to TRUS-MRI-fusion biopsies?

Design: A single-arm, single-center IDEAL stage 2a study (n=85 patients) of patients undergoing prostate biopsy for suspected prostate cancer, where each patient would undergo both a portable MRI-registered biopsy and a TRUS-image-fusion biopsy. To reduce the risk of bias between the two modalities, the order of the modality will be randomized 1:1. There will be no blinding of the surgeon.

The primary outcome will be the technical feasibility of performing portable MRI and portable MRI-targeted biopsies and estimates on cancer detection.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Age 18 years or above (no upper limit)
* Raised age specific PSA
* LIKERT/PIRADS 3 or above lesion on prostate mpMRI who have been advised to undergo a prostate biopsy.

Exclusion Criteria:

* Patients who are unable to undergo a diagnostic standard of care MRI due to metallic implants, foreign body or devices.
* Patients with a Cardiac pacemaker or Implantable cardioverter-defibrillator (ICD).
* Contraindication to performing a biopsy guided by a transrectal ultrasound probe
* Unable to give informed consent to the study

Primary outcomes:
measure: Percentage of Clinicical Significance of Cancer Detected
timeFrame: 2 years
measure: Technical feasibility of performing portable MRI and portable MRI targeted biopsies.
timeFrame: 2 years
Secondary outcomes:
measure: Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
timeFrame: 2 years
measure: Patient reported outcome measures (PROMS / HADS-D) of genitourinary health
timeFrame: 2 years
measure: Overall health-related quality of life as assessed by ICIQ-UI short form
timeFrame: 2 years
measure: Overall health-related quality of life as assessed by IPSS
timeFrame: 2 years
measure: Overall health-related quality of life as assessed by IPSS-QoL
timeFrame: 2 years
measure: Overall health-related quality of life as assessed by EQ5D
timeFrame: 2 years
measure: The sensitivity, specificity, and accuracy of using portable MRI to detect clinically significant prostate cancer
timeFrame: 2 years
measure: Concordance Rate of Prostate Cancer Detection between Portable MRI and Standard mpMRI
timeFrame: 2 years
measure: Patient reported outcome measures (PROMS / EPIC) of genitourinary health
timeFrame: 2 years
measure: Patient reported outcome measures (PROMS / EuroQol) of genitourinary health
timeFrame: 2 years
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Imperial College London
Study officials:
affiliation: Imperial College London
name: Taimur Shah, Dr
role: PRINCIPAL_INVESTIGATOR
References: