[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"psa\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:psa":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,46,74],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":28,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":45},"100632633","mri-assisted-guidance-for-non-essential-tissue-sampling-100632633",false,"NCT07516223","MRI-Assisted Guidance for Non-Essential Tissue Sampling","MRI-Assisted Guidance for Non-Essential Tissue Sampling (MAGNET): an Investigator-initiated, International, Multicentre, Prospective, Pairedcohort, Diagnostic Utility Study","Inclusion Criteria:\n\nAge ≥ 45 years. Serum PSA level ≥ 4.0 ng\u002Fml. High-risk MRI findings: Presence of at least one lesion with a PI-RADS score of 4 (Likely) or 5 (Highly Likely) according to v2.1 guidelines11.\n\nFitness for transperineal prostate biopsy under local or general anaesthesia. Competency to provide informed consent.\n\nExclusion Criteria:\n\nHistory of prior prostate biopsy (to ensure baseline risk homogeneity). Prior treatment for prostate cancer or use of 5-alpha reductase inhibitors (5-ARIs) within 6 months.\n\nCandidates who have explicitly opted for focal therapy prior to biopsy (where systematic mapping remains mandatory).\n\nContraindications to MRI (e.g., incompatible implants, severe renal impairment).\n\nActive urinary tract infection or acute prostatitis.","MALE","45 Years",{"count":19,"type":20},1235,"ESTIMATED","INTERVENTIONAL",[23],"NA","The study aims to determine if a less painful and less invasive prostate biopsy approach is safe for certain men with a high risk of prostate cancer.\n\nCurrently, when a man has a suspicious MRI scan, standard medical guidelines recommend a \"combined biopsy.\" This means the urologist performs a Targeted Biopsy (taking 3-5 tissue samples directly from the suspicious area seen on the MRI) followed immediately by a Systematic Biopsy (taking 12 additional samples blindly from the rest of the prostate). While this combined approach maximizes cancer detection, the 12 extra needles from the systematic biopsy increase the risk of bleeding, pain, and urinary infection.\n\nResearchers believe that for men who already have a very high prostate-specific antigen (PSA) level and a highly suspicious MRI, the targeted biopsy alone might be enough to detect any dangerous cancer. In these high-risk men, the extra 12 systematic needles might offer little to no additional benefit (\"diminishing returns\").\n\nIn this study, 850 men will undergo the standard combined biopsy procedure. However, to test the researchers' theory with extreme precision, the tissue samples from the Targeted Biopsy and the Systematic Biopsy will be placed into completely separate, uniquely barcoded jars (the \"One Core, One Jar\" spatial mapping protocol). The pathologist will examine each tissue sample independently, without knowing which method was used to collect it.\n\nBy comparing the results within each patient, the study will determine exactly how many dangerous cancers were found exclusively by the systematic biopsy. If this number is clinically negligible (less than 5%) in men with high PSA levels, it will prove that the 12 extra needles are unnecessary for this specific group.\n\nThe ultimate goal of the trial is to safely \"de-escalate\" prostate cancer diagnostics-sparing high-risk men from the physical trauma, complications, and costs of unnecessary systematic sampling, while ensuring no dangerous cancers are missed.",[26,27],"PSA Progression","PSA",[29,30,31,32],"prostate biopsy","targeted biopsy","systematic biopsy","MRI","RECRUITING","2026-06-21",{"date":36,"type":37},"2026-06-24","ACTUAL",{"date":39,"type":37},"2026-04-05",{"date":41,"type":20},"2028-05-05",{"name":43,"class":44},"Shanghai East Hospital","OTHER",1,{"id":47,"slug":48,"hasResults":11,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":52,"eligibilityCriteria":53,"healthyVolunteers":11,"sex":16,"minAge":54,"maxAge":4,"enrollmentInfo":55,"targetDuration":4,"studyType":57,"phases":4,"briefSummary":58,"conditions":59,"keywords":61,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":65,"lastUpdatePostDateStruct":66,"startDateStruct":68,"completionDateStruct":70,"leadSponsor":72,"locationsCount":45},"100345992","edrn-prostate-mri-biomarker-study-100345992","NCT03784924","EDRN Prostate MRI Biomarker Study","EDRN Prostate MRI Biomarker Study and Reference Set","P-MRI","Inclusion Criteria:\n\n* Men with suspected but undiagnosed prostate cancer\n* To be scheduled\u002Fscheduled for biopsy as routine clinical care\n\nExclusion Criteria:\n\n* Inability to obtain blood and urine per SOP or conduct an attentive DRE\n* Unable to undergo\u002Ftolerate a prostate MRI or failure to conduct the MRI\n* Prior diagnosis of prostate cancer\n* Prior prostate MRI unless being used as Index MRI (in this case index MRI can be one year prior to consent date)\n* Participating in clinical trial for prostate disease\n* Prior prostate surgery such as TURP, TUNA, TUMT, HOLEP, REZUM, UROlift\n* Prior PCA3, TMPRSS2:erg or MIPS panel performed for clinical purpose","18 Years",{"count":56,"type":20},950,"OBSERVATIONAL","The commercialization of MRI fusion biopsies has resulted in a dramatic increase in the use of MRI imaging for prostate cancer. How best to use MRI in the initial prostate biopsy setting given the availability of validated prostate cancer early detection markers is uncertain.This study will allow investigators to determine if prostate MRI is superior to validated panel of laboratory biomarkers (e.g. PCA3, PSA and TMPRSS2:ERG) in the initial biopsy setting.",[27,60],"Prostate Cancer",[62,63,64,32],"Prostate cancer","psa","early detection","2026-01-06",{"date":67,"type":37},"2026-01-08",{"date":69,"type":37},"2019-02-04",{"date":71,"type":20},"2028-12-31",{"name":73,"class":44},"University of Michigan",{"id":75,"slug":76,"hasResults":11,"nctId":77,"briefTitle":78,"officialTitle":79,"acronym":80,"eligibilityCriteria":81,"healthyVolunteers":11,"sex":16,"minAge":54,"maxAge":82,"enrollmentInfo":83,"targetDuration":4,"studyType":21,"phases":85,"briefSummary":87,"conditions":88,"keywords":90,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":95,"lastUpdatePostDateStruct":96,"startDateStruct":98,"completionDateStruct":100,"leadSponsor":102,"locationsCount":5},"100487623","phase-4-anti-inflammatory-drugs-and-serum-prostate-specific-antigen-test-100487623","NCT05629494","Anti-inflammatory Drugs and Serum Prostate-Specific Antigen Test","Effect of Non-steroidal Anti-inflammatory Drugs on Serum Prostate Specific Antigen Level","ADAPT-PSA","Inclusion Criteria:\n\n* Male patients age between 18-80 years old with a screening PSA \\> 3 ng\u002Fml being considered for additional diagnostic testing (e.g., MRI, biopsy)\n* Normal digital rectal examination within the past two years. A documented normal digital rectal examination by another physician or advanced practice provider (NP, PA, etc) is acceptable.\n* No clinical symptoms concerning for acute urinary tract infection (e.g. dysuria, malodorous urine, positive urine culture)\n\nExclusion Criteria:\n\n* History of hypersensitivity or allergy to ibuprofen or NSAIDs.\n* History of peptic ulcer disease, GI bleeding or NSAIDs induced GI adverse events\n* Known bleeding disorders\n* Known severe chronic kidney disease: eGFR \\\u003C 30 mL\u002Fmin\u002F1.73 m2\n* Heart failure, significant heart disease\n* Poorly controlled hypertension\n* Active urinary tract infections or bacteriuria\n* Concomitant use of 5-alpha reductase inhibitors (finasteride, dutasteride) unless patient has been taking it for at least 6 months\n* Known prostate cancer or underwent prostate MRI or biopsy in the last year\n* Urinary tract instrumentation in the past 6 weeks (catheter, cystoscopy)\n* Concomitant anti-inflammatory or steroidal drugs\n* Concomitant dual-antiplatelet or anticoagulant therapy use except aspirin 81 mg alone\n* Know history of severe liver disease determined by abnormal liver function tests (elevated AST or ALT \\> 3X ULN based on exiting history or labs)\n* Any other medical contraindication to NSAIDs","80 Years",{"count":84,"type":20},198,[86],"PHASE4","Prostate cancer is the most frequently diagnosed cancer in men in the Unites States. Nearly 1 million prostate biopsy procedures are performed in the United States annually and elevated prostate-specific antigen (PSA) level is the primary reason for prostate biopsy in \\> 90% of cases. However, at the PSA levels which trigger prostate biopsy, often no cancer is found in prostate biopsy specimens. PSA test can be elevated due to reasons other than cancer such as inflammation or natural variation in the level. Investigators plan to treat men with elevated PSA level with over the counter anti-inflammatory medications (ibuprofen, naproxen) to see if the PSA level will decrease to an acceptable level.",[60,89,27],"Prostate Inflammation",[91,92,93,94],"Prostate-specific antigen","PSA test","Prostate biopsy","non-steroidal anti-inflammatory drugs NSAIDS","2024-10-17",{"date":97,"type":37},"2024-10-18",{"date":99,"type":37},"2022-09-27",{"date":101,"type":20},"2026-12-01",{"name":103,"class":44},"Albany Medical College"]