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

NCT06453785 | Not Yet Recruiting FDA Device

• 1 other identifier: 22CX7739
• Study Type: interventional
• Target: 85
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostate Cancer

Keywords

biopsy; MRI

Outcome Measures

Primary Outcomes (2)

• Percentage of Clinicical Significance of Cancer Detected

  The proportion of patients with biopsy cores that yield cancer-positive results and the concordance between MRI-guided biopsy results and histopathological findings.

  2 years

• Technical feasibility of performing portable MRI and portable MRI targeted biopsies.

  Percentage of biopsy completed

  2 years

Secondary Outcomes (10)

• Number of participants with treatment-related adverse events as assessed by CTCAE v4.0

  2 years

• Patient reported outcome measures (PROMS / HADS-D) of genitourinary health

  2 years

• Overall health-related quality of life as assessed by ICIQ-UI short form

  2 years

• Overall health-related quality of life as assessed by IPSS

  2 years

• Overall health-related quality of life as assessed by IPSS-QoL

  2 years

Study Arms (1)

Patients with suspected prostate cancer

OTHER

Patients who undergo prostate biopsy for suspected prostate cancer. 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.

Device: Promaxo portable MRI

Interventions

Promaxo portable MRI DEVICE

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 central aperture for robotic guided intervention and has a limited footprint allowing it to be places in a standard operating theatre or large clinic room. The strength of magnet is also low enough that special precautions and equipment are not to take biopsies.

Patients with suspected prostate cancer

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Imperial College London: lead

Study Sites (1)

Imperial College London

London, W6 8RF, United Kingdom

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Taimur Shah, Dr

  Imperial College London

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Taimur Shah, Dr

CONTACT

020 3311 6611; t.shah@imperial.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 25, 2024
• First Posted: June 12, 2024
• Study Start: March 1, 2025
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): July 1, 2027
• Last Updated: June 12, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)