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Updated: Sep 19, 2025
Use of MRI-ultrasound Fusion to Achieve Targeted Prostate Biopsy
Published on: April 9, 2019
Prostate Assessment using Comparative Interventions - Fast MRI and Image-fusion for Cancer (IP7-PACIFIC): A
Nikhil Mayor1, Alexander Light1, Francesca Rawlins2
1Division of Surgery, Department of Surgery and Cancer, Faculty of Medicine, Imperial College London, London, UK; Department of Urology, Imperial College Healthcare National Health Service (NHS) Trust, London, UK.
Background:
Multiparametric MRI (mpMRI) with contrast medium is recommended in the prostate cancer diagnostic pathway. It is unclear if MRI without contrast medium (biparametric [bp]) can be used instead whilst remaining sensitive to detection of clinically significant cancers. For those with a positive MRI, is image-fusion targeting better than visual-registration (cognitive) targeting in detecting clinically significant prostate cancer? And does bpMRI represent better value for money than mpMRI? A randomised controlled trial testing clinical utility and cost-effectiveness of these approaches is vital before changes in practice.
Methods:
IP7-PACIFIC is a prospective, multicentre, co-enrolment trial with two randomisations and embedded economic evaluation. The first randomisation will evaluate non-inferiority of bpMRI compared to mpMRI in those with clinical suspicion of prostate cancer. Men with a suspicious MRI will undergo a second randomisation to evaluate if image-fusion targeting is superior to standard visual-registration targeted biopsy. Ethics committee approval has been granted by the London Bromley Research Ethics Committee.
Results:
The primary objective for Randomisation 1 is to determine non-inferiority of bpMRI to detect Gleason score ≥ 7 [ISUP Grade Group ≥2] cancer compared to mpMRI. The objective for Randomisation 2 is to determine if image-fusion targeted biopsy is superior to visual-registration targeted biopsy. An internal pilot phase will enrol 700 patients; the overall recruitment target is 3600.
Discussion:
IP7-PACIFIC aims to provide randomised comparative evidence for the clinical utility and cost-effectiveness of using bpMRI and image-fusion biopsy. The findings will inform guidelines. The sequential randomised co-enrolment design allows simultaneous evaluation of two research questions and avoids heterogeneity of trial populations. By contrast to previous paired-cohort studies, the randomised design will reduce reporter bias, providing the highest level of diagnostic evidence.
Insights
This study evaluates if MRI without contrast (bpMRI) is as effective as MRI with contrast (mpMRI) for detecting prostate cancer. It also compares image-fusion biopsy to standard biopsy techniques for improved detection and cost-effectiveness.
Area of Science:
- Radiology
- Urology
- Health Economics
Background:
- Multiparametric MRI (mpMRI) with contrast is standard for prostate cancer diagnosis.
- The efficacy and cost-effectiveness of biparametric MRI (bpMRI) without contrast are under investigation.
- The superiority of image-fusion targeted biopsy over visual-registration biopsy requires evaluation.
Purpose of the Study:
- To compare the diagnostic performance of bpMRI versus mpMRI for clinically significant prostate cancer.
- To determine if image-fusion targeted biopsy is superior to visual-registration biopsy.
- To assess the cost-effectiveness of bpMRI compared to mpMRI.
Main Methods:
- A prospective, multicentre, randomized controlled trial (IP7-PACIFIC) with two randomizations.
- Randomization 1: bpMRI vs. mpMRI for detecting Gleason score ≥7 cancer.
- Randomization 2: Image-fusion biopsy vs. visual-registration biopsy for suspicious MRIs.
Main Results:
- The primary outcome for Randomization 1 is to establish non-inferiority of bpMRI.
- The primary outcome for Randomization 2 is to determine the superiority of image-fusion biopsy.
- The trial aims to recruit 3600 patients, with an initial pilot phase of 700 patients.
Conclusions:
- The IP7-PACIFIC trial will provide randomized evidence on the clinical utility and cost-effectiveness of bpMRI and image-fusion biopsy.
- Findings are expected to inform clinical guidelines for prostate cancer diagnostics.
- The study design minimizes bias and provides high-level diagnostic evidence.
