Prostate CancerIP7-PACIFICNCT05574647
Imperial Prostate 7 - Prostate Assessment Using Comparative Interventions - Fast Mri and Image-fusion for Cancer
A study testing bpMRI and Image-Fusion targeted and systematic Biopsy in people with Prostate Cancer and Adenocarcinoma, run by Imperial College London at 15 sites in United Kingdom.
Trial summary
To evaluate the role of biparametric MRI and image-fusion targeted biopsies for the detection of prostate cancer. To determine whether biparametric MRI (bpMRI) could be recommended as an alternative to multiparametric MRI (mpMRI) for the detection of clinically significant prostate cancers in patients at risk. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer, Adenocarcinoma, Prostatic Neoplasms
- What is being tested?
- bpMRI and Image-Fusion targeted and systematic Biopsy
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3,600 participants
- Where
- 15 sitesUnited Kingdom
- Study dates
- 2 Nov 2022to 31 Jan 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 years or above (no upper limit)
- Patients with a prostate (either cis-male gender or trans-female gender with no prior androgen deprivation hormone use at all).
- Referred to hospital and advised to undergo a prostate MRI because of an abnormal digital rectal examination (regardless of PSA level) and/or an elevated PSA (within 6 months of screening visit) PSA >/=3.0ng/ml for age 50-69 years PSA >/=5.0ng/ml for age >/=70 years If family or ethnic risk for prostate cancer, PSA >/=2.5ng/ml for age 45-49 years
- Visible suspicious finding on mpMRI or bpMRI from randomisation 1 requiring a targeted biopsy (MRI score 3, 4, 5 on either Likert or PIRADS schema)
Who cannot join
- PSA >50ng/ml
- Prior prostate MRI or prostate biopsy in the two years prior to screening visit
- Prior diagnosis of prostate cancer
- Contraindication to MRI or gadolinium contrast
- Previous hip replacement to both hips
- Contraindication to performing a biopsy guided by a transrectal ultrasound probe
Show all 9Show fewer
- Randomisation 2
- As above for randomisation 1
- Patient refusal for biopsy
Trial locations and contacts
15 sites in 1 country. Contact the study team or a site near you to ask about taking part.
15 sites in 1 country
United Kingdom15 sites, 15 recruiting
- Recruiting
Basingstoke Hospital
Basingstoke, RG24 9NA
Judith Radmore, 01256 473202 ext. 44115, judith.radmore@hhft.nhs.uk
Richard Hindley
- Recruiting
Southmead Hospital
Bristol, BS10 5NB
Rebecca Cousins, 0117 4148109, urologyresearch@nbt.nhs.uk
Jonathan Aning
- Recruiting
Addenbrooke Hospital, Cambridge
Cambridge
Tristan Barrett
- Recruiting
Cumberland Infirmary
Carlisle, CA2 7HY
Bev Wilkinson, 01228 814397, beverley.wilkinson@ncic.nhs.uk
Rachel Mutch, 01946523410, rachel.mutch@ncic.nhs.uk
- Recruiting
St Peters Hospital
Chertsey
Nimalan Arumainayagam
- Recruiting
Darent valley Hospital
Dartford, DA2 8DA
Carmel Stuart, 01322 428100 ext. 4323, carmel.stuart@nhs.net
Sanjeev Madaan
- Not yet recruiting
Medway Maritime Hospital
Gillingham, Kent, ME7 5NY
Mandeep Badyal, 01634 976513 ext. 6513, Mandeep.badyal@nhs.net
Shikohe Masood
- Recruiting
Northwick Park Hospital
Harrow
Gaurav Mukerji
- Recruiting
St James's Hospital, Leeds
Leeds
Oliver Hulson
- Recruiting
Charing Cross Hospial
London, W6 8RF
Francesca Rawlins, f.rawlins@imperial.ac.uk
Hashim Ahmed, FRCS
- Recruiting
Manchester Royal Infirmary
Manchester
Charlene Hyde, charlene.hyde@mft.nhs.uk
Amar Mr Mohee
- Recruiting
Northampton General Hospital
Northampton
Aakash Pai
- Recruiting
University Hospital Southampton
Southampton, Hampshire, SO16 6YD
Aneta Zahorska, 023 8120 3560, aneta.zahorska@uhs.nhs.uk
Nikki Carney, 023 8120 3560, nikki.carney@uhs.nhs.uk
- Recruiting
Southend University Hospital
Southend-on-Sea, Essex, SS0 0RY
Lesley Nichols, FRCS, 01702 435555 ext. 6411, lesley.nichols1@nhs.net
Peter Archer
- Recruiting
Hillingdon Hospital
Uxbridge, UB8 3NN
Mariam Nasseri, 01895 279021, mariam.nasseri1@nhs.net
Saheel Mukhtar
About this study
Official title: Evaluating the Role of Biparametric MRI and Image-fusion Targeted Biopsies for Detection of Prostate Cancer
To evaluate the role of biparametric MRI and image-fusion targeted biopsies for the detection of prostate cancer.
To determine whether biparametric MRI (bpMRI) could be recommended as an alternative to multiparametric MRI (mpMRI) for the detection of clinically significant prostate cancers in patients at risk.
To determine whether image-fusion targeted biopsy is better than visual-registration (cognitive) targeted biopsy at detecting clinically significant prostate cancers in patients requiring prostate biopsy due to a suspicious MRI.
Read the detailed description
Background and study aims:
The aim of this study is to improve the way prostate cancer is diagnosed by looking at two different types of MRI scans and two different types of prostate biopsy (tissue samples). A large study such as this is required to help the NHS decide how to diagnose prostate cancer in the future. If a person is suspected of having prostate cancer, then they are referred by their GP. At the hospital clinic, the participant will then have an MRI scan. If this scan shows that cancer might be present, then the doctor will usually suggest that the patient has a biopsy. There are two ways of doing a prostate MRI. One takes 30-40 minutes and requires a contrast injection called gadolinium (like a dye). This is called long MRI and is most commonly used in the NHS. Gadolinium is safe as it rarely causes any bad reaction but using it means that the scan takes more time. Another type of MRI takes 15-20 minutes and does not use gadolinium contrast. This is called a short MRI. Many studies over the last 5 years have shown that the long and short MRIs are similar in their accuracy in diagnosing important prostate cancer. These studies have not been of high quality or large enough to change NHS practice. Patients with suspicious areas on the MRI are usually advised to have a prostate biopsy. This involves taking tissue samples using a needle. The samples are then looked at under the microscope by a pathologist to see if cancer cells are present. There are two ways of doing a prostate biopsy. One is where the person doing the biopsy decides where to put the biopsy needle by looking at the MRI scans that have been already taken on a computer screen. The needle is guided to the prostate using live ultrasound scans that are shown on a different screen near the patient. The biopsy operator makes a judgement about where to place the biopsy needles. This is called visual registration. Tissue samples from other areas of the prostate that look normal on the MRI scans are also taken to ensure cancer is not missed. The other type of biopsy is called image fusion. During image fusion biopsy, the biopsy operator uses the MRI scans that have been taken beforehand but laid on top of the live ultrasound images during the biopsy. This uses software and takes a few minutes longer to perform. Once the MRI images and ultrasound images are 'fused', the actual biopsies are taken as normal. Studies over the last 5 years have shown mixed results. Some have shown that image fusion biopsy is no better than visual registration biopsy, whilst a few have shown it might make a difference in improving cancer detection. As a result, it is not known for certain which way is better. A large study is needed to show whether the investigators need to do image fusion or not, in order for the NHS to decide whether or not to use it in all hospitals doing prostate biopsies.
- Being tested
- bpMRI, Image-Fusion targeted and systematic Biopsy
- Keywords
- Prostate Cancer, Prostate-Specific Antigen, bpMRI, mpMRI, Prostate biopsy, Multi-parametric MRI, Biparametric MRI
- Medical subject headings
- Prostatic Neoplasms, Adenocarcinoma, Prostatic Diseases, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bpMRIDiagnostic test
Also called biparametric MRI
biparametric MRI takes 30-40 minutes and requires a contrast injection called gadolinium (like a dye). This is also called long MRI and is most commonly used in the NHS.
Image-Fusion targeted and systematic BiopsyDiagnostic test
During image fusion targeted biopsy, the biopsy operator uses the MRI scans that were taken beforehand but laid on top of the live ultrasound images during the biopsy. This uses software and takes a few minutes longer to perform. Once the MRI images and ultrasound images are 'fused', the actual biopsies are taken as normal.
| Study group | Role | What they receive |
|---|---|---|
| Standard: mpMRI | No intervention | Participants will undergo mpMRI. Blinding will not be possible. Once the MRI report is issued, the local clinical team will make a decision about advising whether a biopsy is necessary or not. |
| Intervention 1: bpMRI | Active comparator | Participants will undergo bpMRI. Blinding will not be possible. Once the MRI report is issued, the local clinical team will make a decision about advising whether a biopsy is necessary or not. Receives: Diagnostic Test: bpMRI |
| Standard: Visual estimation targeted and systematic biopsy | No intervention | Randomisation 2 will only be relevant if participants are advised by their clinical team to have a biopsy based on their MRI and other clinical factors. Participants advised to have a biopsy will undergo a visual estimation targeted biopsy |
| Intervention 2: Image-fusion targeted and systematic biopsy | Active comparator | Randomisation 2 will only be relevant if participants are advised by their clinical team to have a biopsy based on their MRI and other clinical factors. Participants advised to have a biopsy will undergo an image fusion targeted biopsy. Receives: Diagnostic Test: Image-Fusion targeted and systematic Biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Randomisation 1: Proportion of clinically significant cancers detected in the randomised population of patients at risk.
Proportion of clinically significant cancers, defined as any amount of Gleason ≥3+4 (ISUP Grade Group ≥2) on biopsy, detected in the randomised population of patients at risk.
Measured: maximum 12 weeks following enrolment
Randomisation 2: Proportion of clinically significant cancers detected in the randomised population of patients biopsied for a suspicious MRI.
Proportion of clinically significant cancers, defined as any amount of Gleason ≥3+4 (ISUP Grade Group ≥2) on biopsy, detected in the randomised population of patients biopsied for a suspicious MRI.
Measured: maximum 12 weeks following enrolment
Secondary outcomes (22)
MRI related adverse events
MRI related adverse events measured using documentation
Measured: maximum 12 weeks following enrolment
MRI related serious adverse events
MRI related serious adverse events measured using documentation
Measured: maximum 12 weeks following enrolment
Biopsy related adverse events
biopsy-related adverse events measured using documentation
Measured: maximum 12 weeks following enrolment
Biopsy related serious adverse events
biopsy-related serious adverse events measured using documentation
Measured: maximum 12 weeks following enrolment
The proportion of patients advised to undergo a needle biopsy after MRI
The proportion of patients advised to undergo a needle biopsy. The researchers will document common reasons for patients who are advised to undergo a biopsy or advised against a needle biopsy and still choose to have a biopsy.
Measured: maximum 12 weeks following enrolment
The proportion of patients advised to undergo a prostrate biopsy after MRI
The proportion of patients undergoing a prostate biopsy after MRI. The researchers will document common reasons for patients who are advised to undergo prostrate biopsy after MRI.
Measured: maximum 12 weeks following enrolment
The proportion of patients diagnosed with clinically significant prostates cancers on needle biopsy
The proportion of patients diagnosed with clinically significant prostates cancers defined as any Gleason 3+3=6 on needle biopsy carried out after MRI.
Measured: maximum 12 weeks following enrolment
The proportion of patients diagnosed with clinically significant prostate cancers on prostate biopsy carried out after MRI
The proportion of patients diagnosed with clinically significant prostate cancers using other histological thresholds on prostate biopsy carried out after MRI.
The researchers will evaluate these proportions by MRI score at patient and lesion level (on a scale of 1 to 5) and by the presence or absence of clinical risk parameters.
Measured: maximum 12 weeks following enrolment
The proportion of patients diagnosed with clinically significant prostate cancers with targeted biopsy using four targeted cores
The proportion of patients diagnosed with clinically significant prostate cancers using all histological thresholds on targeted biopsy using four targeted cores
Measured: maximum 12 weeks following enrolment
The proportion of patients diagnosed with clinically significant prostate cancers with targeted biopsy using six targeted cores
The proportion of patients diagnosed with clinically significant prostate cancers using all histological thresholds on targeted biopsy using six targeted cores
Measured: maximum 12 weeks following enrolment
Detection rates for each randomised group of known prognostic risk categories
Detection rates for each randomised group of known prognostic risk categories. These are D' Amico, National Comprehensive Cancer Network (NCCN) and Cambridge Prognostic Groups (CPG).
Measured: maximum 12 weeks following enrolment
Use Likert MRI scoring system to analyse the proportion of patients biopsied
A comparison of the two MRI scoring systems, Likert and PIRADS (the latest version as defined in MRI Reporting SOP), in terms of the proportion of patients biopsied and subsequently diagnosed with clinically significant and clinically insignificant prostate cancer, using each of the histological thresholds, on a prostate biopsy.
Measured: maximum 12 weeks following enrolment
Use Prostate Imaging Reporting and Data System (PIRADS) MRI scoring system to analyse the proportion of patients biopsied
A comparison of the two MRI scoring systems, Likert and PIRADS (the latest version as defined in MRI Reporting SOP), in terms of the proportion of patients biopsied and subsequently diagnosed with clinically significant and clinically insignificant prostate cancer, using each of the histological thresholds, on a prostate biopsy.
Measured: maximum 12 weeks following enrolment
Characteristics of cancer in targeted systematic biopsies
Characteristics of cancer in targeted versus systematic biopsies by MRI score, PSA, PSA density, age, ethnicity, family history and history of prior prostate biopsy with a multivariable evaluation to determine whether patients might avoid systematic sampling in the future.
Measured: maximum 12 weeks following enrolment
Characteristics of cancer in targeted biopsies
Characteristics of cancer in targeted versus systematic biopsies by MRI score, PSA, PSA density, age, ethnicity, family history and history of prior prostate biopsy with a multivariable evaluation to determine whether patients might avoid systematic sampling in the future.
Measured: maximum 12 weeks following enrolment
External validation of the Imperial Rapid Access to Prostate Imaging and Diagnosis (RAPID) Risk Score (MRI+)
External validation of the Imperial RAPID Risk Score (MRI+) within each randomised group of the IP7-PACIFIC study, external validation
Measured: maximum 12 weeks following enrolment
External validation of the Imperial Rapid Access to Prostate Imaging and Diagnosis (RAPID) Risk Score in (Systematic+)
External validation of Imperial Rapid Access to Prostate Imaging and Diagnosis(RAPID) Risk Score (Systematic+) within each randomised group of the IP7-PACIFIC study, external validation
Measured: maximum 12 weeks following enrolment
Impact of prostate biopsy in first randomised group (bpMRI) on patient-reported outcomes
Impact of prostate biopsy in each randomised group on patient-reported outcomes using a survey that includes EQ-5D-5L health-related quality of life questionnaire
Measured: maximum 12 weeks following enrolment
Impact of prostate biopsy in second randomised group (mpMRI)on patient-reported outcomes
Impact of prostate biopsy in each randomised group on patient-reported outcomes using a survey that includes EQ-5D-5L health-related quality of life questionnaire
Measured: maximum 12 weeks following enrolment
Impact of prostate biopsy in first randomised group (bpMRI) on patient-reported experience measures
Impact of prostate biopsy in each randomised group on patient-reported experience measures using version of the Prospective cohort study (Prostate Biopsy Effects: ProBE) questionnaire.
Measured: maximum 12 weeks following enrolment
Impact of prostate biopsy in second randomised group (mpMRI) on patient-reported experience measures
Impact of prostate biopsy in each randomised group on patient-reported experience measures using version of the Prospective cohort study (Prostate Biopsy Effects: ProBE) questionnaire.
Measured: maximum 12 weeks following enrolment
Analysis of biopsy rate in cancer detection (by all histological thresholds) during the time of study
Analysis of biopsy rates in cancer detection (by all histological thresholds) in the randomised group will be conducted by centre using centre size.
MRI scanner type (1.5 Tesla vs. 3.0 Tesla), type of biopsy route used (transrectal vs trans perineal), number of systematic biopsies taken (limited systematic vs extended systematic biopsy), type of analgesia/anaesthetic (local anaesthetic, sedation or general anaesthetic) as additional stratification factors
Measured: maximum 12 weeks following enrolment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2022
- Study start2 Nov 2022
- Primary completion31 Oct 2025 (estimated)
- Study completion31 Jan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by Imperial College LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- two linked RCTs which will test whether bpMRI and image-fusion make a difference if used in clinical practice, across multiple centres, without the incorporation bias inherent in paired-cohort studies
- Masking
- None (open label)
- Enrolment
- 3,600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Imperial College London
- Sponsor type
- University, hospital or other
- Collaborators
- Cancer Research UK, National Institute for Health Research, United Kingdom
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05574647
- Sponsor's protocol ID
- 22CX7488
- Acronym
- IP7-PACIFIC
- Status last verified
- Jul 2025
- First submitted
- 3 Aug 2022
- Last updated
- 24 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Mayor N, Light A, Rawlins F, Cullen E, Klimowska-Nassar N, Sasikaran T, Jadav P, Sokhi H, Smith A, Walls D, Oldroyd R, Price D, Robinson C, Lane E, Rockall A, Heer R, Vale L, Padhani AR, Winkler M, Shah TT, Gabe R, Ahmed HU. Prostate Assessment using Comparative Interventions - Fast MRI and Image-fusion for Cancer (IP7-PACIFIC): A prospective, multi-centre, dual sequential randomised controlled trial. Contemp Clin Trials. 2025 Aug;155:107983. doi: 10.1016/j.cct.2025.107983. Epub 2025 Jun 6.
PubMed 40484273
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Role of Biparametric MRI and Image-fusion Targeted Biopsies for Detection of Prostate Cancer
- ClinicalTrials.gov ID
- NCT05574647
- Acronym / sponsor ID
- IP7-PACIFIC / 22CX7488
- Keywords
- Prostate Cancer, Prostate-Specific Antigen, bpMRI, mpMRI, Prostate biopsy, Multi-parametric MRI, Biparametric MRI
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 3,600 participants (estimated)
- Lead sponsor
- Imperial College LondonUniversity, hospital or other
- Collaborators
- Cancer Research UK, National Institute for Health Research, United Kingdom
- Study start
- 2 Nov 2022 (actual)
- Primary completion
- 31 Oct 2025 (estimated)
- Study completion
- 31 Jan 2026 (estimated)
- First posted
- 10 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To evaluate the role of biparametric MRI and image-fusion targeted biopsies for the detection of prostate cancer.
To determine whether biparametric MRI (bpMRI) could be recommended as an alternative to multiparametric MRI (mpMRI) for the detection of clinically significant prostate cancers in patients at risk.
To determine whether image-fusion targeted biopsy is better than visual-registration (cognitive) targeted biopsy at detecting clinically significant prostate cancers in patients requiring prostate biopsy due to a suspicious MRI.
Detailed description
Background and study aims:
The aim of this study is to improve the way prostate cancer is diagnosed by looking at two different types of MRI scans and two different types of prostate biopsy (tissue samples). A large study such as this is required to help the NHS decide how to diagnose prostate cancer in the future. If a person is suspected of having prostate cancer, then they are referred by their GP. At the hospital clinic, the participant will then have an MRI scan. If this scan shows that cancer might be present, then the doctor will usually suggest that the patient has a biopsy. There are two ways of doing a prostate MRI. One takes 30-40 minutes and requires a contrast injection called gadolinium (like a dye). This is called long MRI and is most commonly used in the NHS. Gadolinium is safe as it rarely causes any bad reaction but using it means that the scan takes more time. Another type of MRI takes 15-20 minutes and does not use gadolinium contrast. This is called a short MRI. Many studies over the last 5 years have shown that the long and short MRIs are similar in their accuracy in diagnosing important prostate cancer. These studies have not been of high quality or large enough to change NHS practice. Patients with suspicious areas on the MRI are usually advised to have a prostate biopsy. This involves taking tissue samples using a needle. The samples are then looked at under the microscope by a pathologist to see if cancer cells are present. There are two ways of doing a prostate biopsy. One is where the person doing the biopsy decides where to put the biopsy needle by looking at the MRI scans that have been already taken on a computer screen. The needle is guided to the prostate using live ultrasound scans that are shown on a different screen near the patient. The biopsy operator makes a judgement about where to place the biopsy needles. This is called visual registration. Tissue samples from other areas of the prostate that look normal on the MRI scans are also taken to ensure cancer is not missed. The other type of biopsy is called image fusion. During image fusion biopsy, the biopsy operator uses the MRI scans that have been taken beforehand but laid on top of the live ultrasound images during the biopsy. This uses software and takes a few minutes longer to perform. Once the MRI images and ultrasound images are 'fused', the actual biopsies are taken as normal. Studies over the last 5 years have shown mixed results. Some have shown that image fusion biopsy is no better than visual registration biopsy, whilst a few have shown it might make a difference in improving cancer detection. As a result, it is not known for certain which way is better. A large study is needed to show whether the investigators need to do image fusion or not, in order for the NHS to decide whether or not to use it in all hospitals doing prostate biopsies.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- two linked RCTs which will test whether bpMRI and image-fusion make a difference if used in clinical practice, across multiple centres, without the incorporation bias inherent in paired-cohort studies
| Arm | Type | Receives |
|---|---|---|
| Standard: mpMRI | No intervention | –Participants will undergo mpMRI. Blinding will not be possible. Once the MRI report is issued, the local clinical team will make a decision about advising whether a biopsy is necessary or not. |
| Intervention 1: bpMRI | Active comparator | Diagnostic Test: bpMRIParticipants will undergo bpMRI. Blinding will not be possible. Once the MRI report is issued, the local clinical team will make a decision about advising whether a biopsy is necessary or not. |
| Standard: Visual estimation targeted and systematic biopsy | No intervention | –Randomisation 2 will only be relevant if participants are advised by their clinical team to have a biopsy based on their MRI and other clinical factors. Participants advised to have a biopsy will undergo a visual estimation targeted biopsy |
| Intervention 2: Image-fusion targeted and systematic biopsy | Active comparator | Diagnostic Test: Image-Fusion targeted and systematic BiopsyRandomisation 2 will only be relevant if participants are advised by their clinical team to have a biopsy based on their MRI and other clinical factors. Participants advised to have a biopsy will undergo an image fusion targeted biopsy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age 18 years or above (no upper limit)
- Patients with a prostate (either cis-male gender or trans-female gender with no prior androgen deprivation hormone use at all).
- Referred to hospital and advised to undergo a prostate MRI because of an abnormal digital rectal examination (regardless of PSA level) and/or an elevated PSA (within 6 months of screening visit) PSA >/=3.0ng/ml for age 50-69 years PSA >/=5.0ng/ml for age >/=70 years If family or ethnic risk for prostate cancer, PSA >/=2.5ng/ml for age 45-49 years
- Visible suspicious finding on mpMRI or bpMRI from randomisation 1 requiring a targeted biopsy (MRI score 3, 4, 5 on either Likert or PIRADS schema)
Key exclusion criteria (9 listed)
- PSA >50ng/ml
- Prior prostate MRI or prostate biopsy in the two years prior to screening visit
- Prior diagnosis of prostate cancer
- Contraindication to MRI or gadolinium contrast
- Previous hip replacement to both hips
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| bpMRIAlso: biparametric MRIbiparametric MRI takes 30-40 minutes and requires a contrast injection called gadolinium (like a dye). This is also called long MRI and is most commonly used in the NHS. | Diagnostic test | Intervention 1: bpMRI |
| Image-Fusion targeted and systematic BiopsyDuring image fusion targeted biopsy, the biopsy operator uses the MRI scans that were taken beforehand but laid on top of the live ultrasound images during the biopsy. This uses software and takes a few minutes longer to perform. Once the MRI images and ultrasound images are 'fused', the actual biopsies are taken as normal. | Diagnostic test | Intervention 2: Image-fusion targeted and systematic biopsy |
Primary outcome
Randomisation 1: Proportion of clinically significant cancers detected in the randomised population of patients at risk.
Time frame: maximum 12 weeks following enrolment
Proportion of clinically significant cancers, defined as any amount of Gleason ≥3+4 (ISUP Grade Group ≥2) on biopsy, detected in the randomised population of patients at risk.
Randomisation 2: Proportion of clinically significant cancers detected in the randomised population of patients biopsied for a suspicious MRI.
Time frame: maximum 12 weeks following enrolment
Proportion of clinically significant cancers, defined as any amount of Gleason ≥3+4 (ISUP Grade Group ≥2) on biopsy, detected in the randomised population of patients biopsied for a suspicious MRI.
22 secondary outcomes
MRI related adverse events
Time frame: maximum 12 weeks following enrolment
MRI related serious adverse events
Time frame: maximum 12 weeks following enrolment
Biopsy related adverse events
Time frame: maximum 12 weeks following enrolment
Biopsy related serious adverse events
Time frame: maximum 12 weeks following enrolment
The proportion of patients advised to undergo a needle biopsy after MRI
Time frame: maximum 12 weeks following enrolment
The proportion of patients advised to undergo a prostrate biopsy after MRI
Time frame: maximum 12 weeks following enrolment
The proportion of patients diagnosed with clinically significant prostates cancers on needle biopsy
Time frame: maximum 12 weeks following enrolment
The proportion of patients diagnosed with clinically significant prostate cancers on prostate biopsy carried out after MRI
Time frame: maximum 12 weeks following enrolment
The proportion of patients diagnosed with clinically significant prostate cancers with targeted biopsy using four targeted cores
Time frame: maximum 12 weeks following enrolment
The proportion of patients diagnosed with clinically significant prostate cancers with targeted biopsy using six targeted cores
Time frame: maximum 12 weeks following enrolment
Detection rates for each randomised group of known prognostic risk categories
Time frame: maximum 12 weeks following enrolment
Use Likert MRI scoring system to analyse the proportion of patients biopsied
Time frame: maximum 12 weeks following enrolment
Use Prostate Imaging Reporting and Data System (PIRADS) MRI scoring system to analyse the proportion of patients biopsied
Time frame: maximum 12 weeks following enrolment
Characteristics of cancer in targeted systematic biopsies
Time frame: maximum 12 weeks following enrolment
Characteristics of cancer in targeted biopsies
Time frame: maximum 12 weeks following enrolment
External validation of the Imperial Rapid Access to Prostate Imaging and Diagnosis (RAPID) Risk Score (MRI+)
Time frame: maximum 12 weeks following enrolment
External validation of the Imperial Rapid Access to Prostate Imaging and Diagnosis (RAPID) Risk Score in (Systematic+)
Time frame: maximum 12 weeks following enrolment
Impact of prostate biopsy in first randomised group (bpMRI) on patient-reported outcomes
Time frame: maximum 12 weeks following enrolment
Impact of prostate biopsy in second randomised group (mpMRI)on patient-reported outcomes
Time frame: maximum 12 weeks following enrolment
Impact of prostate biopsy in first randomised group (bpMRI) on patient-reported experience measures
Time frame: maximum 12 weeks following enrolment
Impact of prostate biopsy in second randomised group (mpMRI) on patient-reported experience measures
Time frame: maximum 12 weeks following enrolment
Analysis of biopsy rate in cancer detection (by all histological thresholds) during the time of study
Time frame: maximum 12 weeks following enrolment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2025.
- Derived from this study: PubMed 40484273Mayor N, Light A, Rawlins F, Cullen E, Klimowska-Nassar N, Sasikaran T, Jadav P, Sokhi H, Smith A, Walls D, Oldroyd R, Price D, Robinson C, Lane E, Rockall A, Heer R, Vale L, Padhani AR, Winkler M, Shah TT, Gabe R, Ahmed HU. Prostate Assessment using Comparative Interventions - Fast MRI and Image-fusion for Cancer (IP7-PACIFIC): A prospective, multi-centre, dual sequential randomised controlled trial. Contemp Clin Trials. 2025 Aug;155:107983. doi: 10.1016/j.cct.2025.107983. Epub 2025 Jun 6.
- Individual participant dataSharing planned: No
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Breast Neoplasms, Colorectal Neoplasms
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing bpMRI and Image-Fusion targeted and systematic Biopsy in people with Prostate Cancer and Adenocarcinoma, run by Imperial College London at 15 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hashim Ahmed (0203 311 1673, hashim.ahmed@imperial.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Randomisation 1: Proportion of clinically significant cancers detected in the randomised population of patients at risk. (time frame: maximum 12 weeks following enrolment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05574647, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2025.