Study Comparing Biparametric and Multiparametric MRI with Different Targeted Biopsies to Detect Prostate Cancer in Men
Led by Imperial College London · Updated on 2025-07-24
3600
Participants Needed
15
Research Sites
13 weeks
Total Duration
AI-Summary
What this Trial Is About
Researchers are evaluating the use of two types of MRI scans and two biopsy methods to improve prostate cancer diagnosis. The study focuses on whether biparametric MRI bpMRI, which is shorter and does not use contrast dye, can be an alternative to the longer multiparametric MRI mpMRI that uses gadolinium contrast. It also compares image-fusion targeted biopsy, which overlays MRI and ultrasound images during biopsy, with visual-registration targeted biopsy, where biopsy locations are chosen by looking at MRI images separately.
Participants first receive either the mpMRI or bpMRI scan. If the MRI suggests cancer, the clinical team decides if a biopsy is needed. Those advised for biopsy undergo either a visual-registration targeted biopsy or an image-fusion targeted biopsy. Both biopsy methods include taking systematic tissue samples to check for cancer. The study does not blind participants or doctors to the MRI or biopsy type used.
During the study, participants undergo MRI scans and possibly biopsies based on clinical advice. Researchers collect data on how many clinically significant prostate cancers are detected within 12 weeks of enrollment. They also assess any adverse events related to MRI and biopsy procedures, patient-reported outcomes, and accuracy of cancer detection using different scoring systems. The total duration for outcome assessment is up to 12 weeks after joining the study.
CONDITIONS
Brief Title
Imperial Prostate 7 - Prostate Assessment Using Comparative Interventions - Fast Mri and Image-fusion for Cancer
Research Team
H
Hashim Ahmed
T
Thiagarajah Sasikaran
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Contraindication to biopsy guided by transrectal ultrasound
Patient refusal for biopsy (for randomisation 2)
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Diagnostic Evaluation
Duration - Up to 12 weeks following enrolment
Participants undergo MRI scans to assess the presence of suspicious areas in the prostate. Depending on the group, participants receive either a long MRI with contrast (bpMRI) or a standard mpMRI without contrast.
1 MRI scan visit (in-person)
Diagnostic Evaluation
Duration - Up to 12 weeks following enrolment
Participants advised to have a biopsy based on MRI results undergo either a visual estimation targeted biopsy or an image fusion targeted biopsy using MRI and ultrasound guidance to collect tissue samples.
1 biopsy visit (in-person)
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
DIAGNOSTIC
Number of Arms
4
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Published Research Related To This Trial
Prostate Assessment using Comparative Interventions - Fast MRI and Image-fusion for Cancer (IP7-PACIFIC): A prospective, multi-centre, dual sequential randomised controlled trial.
Nikhil Mayor, Alexander Light, Francesca Rawlins...