[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100483408":3},{"organization":4,"armGroups":7,"interventions":27,"overallOfficials":12,"centralContacts":39,"locations":49,"responsibleParty":282,"collaborators":284,"id":290,"slug":291,"hasResults":292,"nctId":293,"briefTitle":294,"officialTitle":295,"acronym":296,"eligibilityCriteria":297,"healthyVolunteers":292,"sex":298,"minAge":299,"maxAge":12,"enrollmentInfo":300,"targetDuration":12,"studyType":303,"phases":304,"briefSummary":306,"conditions":307,"keywords":313,"overallStatus":52,"whyStopped":12,"lastUpdateSubmitDate":319,"lastUpdatePostDateStruct":320,"startDateStruct":323,"completionDateStruct":325,"leadSponsor":327,"locationsCount":328},{"fullName":5,"class":6},"Imperial College London","OTHER",[8,13,19,22],{"label":9,"type":10,"description":11,"interventionNames":12},"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.",null,{"label":14,"type":15,"description":16,"interventionNames":17},"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.",[18],"Diagnostic Test: bpMRI",{"label":20,"type":10,"description":21,"interventionNames":12},"Standard: Visual estimation targeted and systematic biopsy","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",{"label":23,"type":15,"description":24,"interventionNames":25},"Intervention 2: Image-fusion targeted and systematic biopsy","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.",[26],"Diagnostic Test: Image-Fusion targeted and systematic Biopsy",[28,35],{"type":29,"name":30,"description":31,"armGroupLabels":32,"otherNames":33},"DIAGNOSTIC_TEST","bpMRI","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.",[14],[34],"biparametric MRI",{"type":29,"name":36,"description":37,"armGroupLabels":38,"otherNames":12},"Image-Fusion targeted and systematic Biopsy","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.",[23],[40,45],{"name":41,"role":42,"phone":43,"phoneExt":12,"email":44},"Hashim Ahmed","CONTACT","0203 311 1673","hashim.ahmed@imperial.ac.uk",{"name":46,"role":42,"phone":47,"phoneExt":12,"email":48},"Thiagarajah Sasikaran","0207 594 6017","t.sasikaran@imperial.ac.uk",[50,73,93,112,129,145,156,176,187,204,215,226,241,255,266],{"facility":51,"status":52,"city":53,"state":54,"zip":55,"country":56,"countryCode":57,"cosmosGeoPoint":58,"geoPoint":63,"contacts":64},"Southend University Hospital","RECRUITING","Southend-on-Sea","Essex","SS0 0RY","United Kingdom","UK",{"type":59,"coordinates":60},"Point",[61,62],0.71433,51.53782,{"lat":62,"lon":61},[65,70],{"name":66,"role":42,"phone":67,"phoneExt":68,"email":69},"Lesley Nichols, FRCS","01702 435555","6411","lesley.nichols1@nhs.net",{"name":71,"role":72,"phone":12,"phoneExt":12,"email":12},"Peter 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Hospital","Northampton",{"type":59,"coordinates":259},[260,261],-0.88333,52.25,{"lat":261,"lon":260},[264],{"name":265,"role":72,"phone":12,"phoneExt":12,"email":12},"Aakash Pai",{"facility":267,"status":52,"city":268,"state":12,"zip":269,"country":56,"countryCode":57,"cosmosGeoPoint":270,"geoPoint":274,"contacts":275},"Hillingdon Hospital","Uxbridge","UB8 3NN",{"type":59,"coordinates":271},[272,273],-0.48211,51.5489,{"lat":273,"lon":272},[276,280],{"name":277,"role":42,"phone":278,"phoneExt":12,"email":279},"Mariam Nasseri","01895 279021","mariam.nasseri1@nhs.net",{"name":281,"role":72,"phone":12,"phoneExt":12,"email":12},"Saheel Mukhtar",{"type":283,"investigatorFullName":12,"investigatorTitle":12,"investigatorAffiliation":12,"oldNameTitle":12,"oldOrganization":12},"SPONSOR",[285,287],{"name":286,"class":6},"Cancer Research UK",{"name":288,"class":289},"National Institute for Health Research, United Kingdom","OTHER_GOV","100483408","imperial-prostate-7---prostate-assessment-using-comparative-interventions---fast-mri-and-image-fusion-for-cancer-100483408",false,"NCT05574647","Imperial Prostate 7 - Prostate Assessment Using Comparative Interventions - Fast Mri and Image-fusion for Cancer","Evaluating the Role of Biparametric MRI and Image-fusion Targeted Biopsies for Detection of Prostate Cancer","IP7-PACIFIC","Randomisation 1\n\nInclusion Criteria:\n\n* Age 18 years or above (no upper limit)\n* Patients with a prostate (either cis-male gender or trans-female gender with no prior androgen deprivation hormone use at all).\n* Referred to hospital and advised to undergo a prostate MRI because of an abnormal digital rectal examination (regardless of PSA level) and\u002For an elevated PSA (within 6 months of screening visit) PSA \\>\u002F=3.0ng\u002Fml for age 50-69 years PSA \\>\u002F=5.0ng\u002Fml for age \\>\u002F=70 years If family or ethnic risk for prostate cancer, PSA \\>\u002F=2.5ng\u002Fml for age 45-49 years\n\nExclusion Criteria:\n\n* PSA \\>50ng\u002Fml\n* Prior prostate MRI or prostate biopsy in the two years prior to screening visit\n* Prior diagnosis of prostate cancer\n* Contraindication to MRI or gadolinium contrast\n* Previous hip replacement to both hips\n* Contraindication to performing a biopsy guided by a transrectal ultrasound probe\n\nRandomisation 2\n\nInclusion Criteria:\n\n* 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)\n\nExclusion Criteria:\n\n* As above for randomisation 1\n* Patient refusal for biopsy","MALE","18 Years",{"count":301,"type":302},3600,"ESTIMATED","INTERVENTIONAL",[305],"NA","To evaluate the role of biparametric MRI and image-fusion targeted biopsies for the detection of prostate cancer.\n\nTo 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.\n\nTo 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.",[308,309,310,311,312],"Prostate Cancer","Adenocarcinoma","Prostatic Neoplasms","Prostatic Diseases","Neoplasms",[308,314,30,315,316,317,318],"Prostate-Specific Antigen","mpMRI","Prostate biopsy","Multi-parametric MRI","Biparametric MRI","2025-07-21",{"date":321,"type":322},"2025-07-24","ACTUAL",{"date":324,"type":322},"2022-11-02",{"date":326,"type":302},"2026-01-31",{"name":5,"class":6},15]