{"registry": "ISRCTN", "registryId": "ISRCTN16082556", "source": "https://www.isrctn.com/ISRCTN16082556", "apiSource": "https://www.isrctn.com/api/trial/ISRCTN16082556/format/default", "fetchedAt": "2026-10-07T17:01:26.318554Z", "license": "CC BY 4.0", "licenseSource": "https://www.isrctn.com/page/faqs#licence-to-post", "study": {"title": "Prostate MRI imaging study", "scientificTitle": "PROstate MRI Imaging Study (PROMIS): evaluation of multi-parametric magnetic imaging in the diagnosis and characterisation of prostate cancer", "acronym": "PROMIS", "hypothesis": "1. In men identified with clinical suspicion of prostate cancer, those with favourable MP-MRI results could safely avoid unnecessary biopsy\n2. An MP-MRI based pathway can improve the rate of detection of clinically significant cancer as compared to TRUS biopsy\n3. An MP-MRI based diagnostic pathway can be cost-effective\n\nMore details can be found at: https://www.journalslibrary.nihr.ac.uk/programmes/hta/092267/#/", "primaryOutcome": "1. Proportion of men who could safely avoid biopsy as determined by specificity and negative predictive values\n2. Proportion of men correctly identified by MP-MRI to have clinically significant prostate cancer as determined by sensitivity and positive predictive values [an overall MP-MRI score will be given from 1-5 (definite benign 1, probably benign 2, indeterminate 3, probably malignant 4, definitely malignant 5), where the primary definition of a positive result is MP-MRI score of ≥3]\n3. Primary definition of cancer according to biopsy: Dominant Gleason pattern ≥ 4 and/or cancer core length ≥ 6 mm", "secondaryOutcome": "1. Evaluation of MRI according to secondary definition of prostate cancer (Dominant Gleason pattern ≥ 4 and/or cancer core length ≥ 4 mm)\n2. Evaluation of the optimal combination of MP-MRI parameters (T2, DW, DCE) \n3. Cost-effectiveness\n4. Inter-observer variation in the reporting of MP-MRI\n5. Evaluation of factors associated with detection of clinically significant prostate cancer\n6. Outcomes associated with translational work", "intervention": "\n\tAll patients will receive the same treatment - Multi-parametric MRI scan and the combined prostate biopsy procedure (Template Prostate Mapping biopsy [TPM], followed by Trans Rectal Ultrasound Biopsy [TRUS]).\n\tOther\n\tNot Applicable\n\t\n      ", "condition": "\n\tProstate cancer\n\tCancer\n\tMalignant neoplasm of prostate\n      ", "studyDesign": "Prospective validating paired cohort study", "overallEndDate": "2015-04-28T00:00:00.000Z", "clinicalTrialsGovNumber": "NCT01292291", "lastUpdated": "2022-03-24T14:52:03.962Z", "eligibility": {"inclusion": "1. Are aged 18 years or over, are at risk of prostate cancer and have been advised to have a prostate biopsy\n2. Have a serum prostate-specific antigen (PSA) value of less than or equal 15ng/ml in the last 3 months\n3. Have suspected less than or equal T2 on rectal examination\n4. Are fit for general/spinal anaesthesia and all study procedures", "exclusion": "Current exclusion criteria as of 22/05/2012:\n1. Have been treated using 5-alpha reductase inhibitors at time of registration or during the prior 6 months\n2. Have a previous history of prostate biopsy, prostate surgery or treatment for prostate cancer\n3. Have urinary tract infection or history of acute prostatitis within the last 3 months\n4. Have a contraindication to MRI or any other medical condition precluding study procedures\n5. Previous history of hip replacement surgery, metallic hip replacement or extensive pelvic orthopaedic metal work. \n\nPrevious exclusion criteria:\n1. Have been treated using 5-alpha reductase inhibitors at time of registration or during the prior 6 months\n2. Have a previous history of prostate biopsy, prostate surgery or treatment for prostate cancer\n3. Have urinary tract infection or history of acute prostatitis within the last 3 months\n4. Have a contraindication to MRI or any other medical condition precluding study procedures\n5. Have previous history of hip replacement surgery", "ageRange": "Adult", "gender": "Male", "participantType": "Patient"}, "recruitment": {"recruitmentStart": "2012-03-28T00:00:00.000Z", "recruitmentEnd": "2015-04-28T00:00:00.000Z", "recruitmentStatusOverride": "", "recruitmentStartStatusOverride": "", "targetEnrolment": "714", "totalFinalEnrolment": ""}, "countries": ["United Kingdom", "England"], "locations": [{"name": "MRC Clinical Trials Unit at UCL", "city": "London", "state": "", "country": "United Kingdom", "zip": "WC2B 6NH"}], "sponsors": [{"organisation": "University College London (UK)", "sponsorType": "University/education", "rorId": "https://ror.org/02jx3x895"}], "funders": [{"name": "Health Technology Assessment Programme", "fundRef": "http://dx.doi.org/10.13039/501100000664"}]}, "studySha256": "fa7642413803727c0fd9ff0cc3962ef6810b8bfc9021e4fbdf74096ce661773d"}