[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"prostate-cancer-diagnosis\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:prostate-cancer-diagnosis":26},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,28,0,25,[9,47,75,99,126,161,194,218,243,263,291,332,359,386,405,431,459,484,516,541,567,592,619,643,669],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":29,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":46},"100610115","phase-2-high-cardiovascular-risk-intervention-with-cardio-oncology-consultation-for-prostate-cancer-following-androgen-receptor-pathway-inhibitor-arpi-therapy-heart-safe-100610115",false,"NCT07223385","High Cardiovascular Risk Intervention With Cardio-Oncology Consultation for Prostate Cancer Following Androgen Receptor Pathway Inhibitor (ARPI) Therapy (Heart-Safe)","Inclusion Criteria:\n\n* Prostate cancer with localized, very-high risk, lymph-node positive, and\u002For metastatic (Stage IV) disease.\n* Being treated with ARPI therapy with intended duration ≥ 18 months.\n* Age \\> 65 years old and at least one CV risk factor, or age 45-65 years with at least two CV risk factors:\n\n  * Hypertension\n  * Hyperlipidemia\n  * Diabetes mellitus\n  * Family history of early CAD (male first-degree relative (father or brother) with CAD before age 55; female first-degree relative (mother or sister) with CAD before age 65)\n  * Presence of coronary artery calcium (CAC) on chest CT imaging\n* ECOG 0-2\n* Written informed consent obtained from subject and ability for subject to comply with the requirements of the study.\n\nExclusion Criteria:\n\n* Prior ARPI therapy exposure \\> 6 months duration.\n* Established care with cardio-oncologist (cardiologist with expertise in CV risks of cancer and cardiotoxic cancer therapies).","MALE","45 Years",{"count":19,"type":20},80,"ESTIMATED","INTERVENTIONAL",[23],"PHASE2","In patients with prostate cancer (PC), cardiovascular disease (CVD) causes significant morbidity and is the second leading cause of death. Both pre-existing CVD and the use of androgen deprivation therapy (ADT)-a key cornerstone of treatment for men with locally advanced or metastatic PC1,2 contribute to increased CV risk. ADT has been associated with adverse metabolic effects, including increased central adiposity, elevated low-density lipoprotein (LDL) levels, impaired glycemic control, and arterial wall remodeling and endothelial dysfunction\n\nThe data demonstrates that for most patients, the status quo is insufficient6 and there remains a critical gap in the early identification of high CV-risk PC patients who may benefit most from aggressive risk mitigation strategies. Mitigation strategies, like the addition of statins as primary prevention, have shown decrease in MI\u002FCHD death across thousands of patients. Age-related expansion of hematopoietic clones carrying recurrent somatic mutations, termed clonal hematopoiesis of indeterminate potential (CHIP) has recently been identified as a significant driver of atherosclerosis, doubling the risk of coronary heart disease. Notably, while CHIP is detectable in \\~10% of persons over 70 years old, it is enriched in patients with solid malignancies, and radiotherapy exposure is among the most decisive risk factors for developing CHIP12-15. The inflammation-related metabolic signals are activated androgen signaling and exacerbated in patients with CHIP. However, the mechanistic link and clinical consequence are less understood. Therefore, it is critical to study the CV impact of CHIP and metabolic perturbations in patients with PC treated with ARSI therapy.\n\nWe plan to address these critical gaps by testing our innovative hypothesis that early cardio-oncology intervention with aggressive guidelines-based CV optimization during ARPI therapy will reduce CV risk and that CHIP and metabolomics will help identify adverse metabolic remodeling to improve CV risk prediction.\n\nRobust epidemiological and clinical trial data consistently demonstrate that patients with PC are poorly optimized from a CV risk modification perspective, and existing CV risk models do not perform well in patients with cancer. The data demonstrates that for most patients, the status quo is insufficient and there remains a critical gap in the early identification of high CV-risk PC patients who may benefit most from aggressive risk mitigation strategies.",[26,27,28],"Prostate Cancer (Diagnosis)","Prostate Cancer Stage IV","CV Risk",[30,31,32,33],"High-Risk","Lymph-node positive","ARPI Therapy","CV Risk Factors","RECRUITING","2026-06-24",{"date":37,"type":38},"2026-06-29","ACTUAL",{"date":40,"type":20},"2026-08-01",{"date":42,"type":20},"2030-08",{"name":44,"class":45},"Cedars-Sinai Medical Center","OTHER",1,{"id":48,"slug":49,"hasResults":12,"nctId":50,"briefTitle":51,"officialTitle":51,"acronym":4,"eligibilityCriteria":52,"healthyVolunteers":12,"sex":53,"minAge":54,"maxAge":4,"enrollmentInfo":55,"targetDuration":4,"studyType":21,"phases":57,"briefSummary":59,"conditions":60,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":65,"lastUpdatePostDateStruct":66,"startDateStruct":68,"completionDateStruct":70,"leadSponsor":72,"locationsCount":74},"100559048","evaluating-the-implementation-of-a-comprehensive-multilevel-virtual-oncology-program-among-veterans-diagnosed-with-lung-colorectal-prostate-and-breast-cancers-in-the-us-department-of-veterans-affairs-100559048","NCT06559059","Evaluating the Implementation of a Comprehensive Multilevel Virtual Oncology Program Among Veterans Diagnosed With Lung, Colorectal, Prostate, and Breast Cancers in the US Department of Veterans Affairs","Patients Inclusion Criteria:\n\n1. A Veteran\n2. Aged 18 years or older\n3. Newly diagnosed with lung, prostate, breast, or colon cancer within 3 months of telemedicine visit\n4. Engaged in an oncology visit during the 36-month analysis period at a Veterans Affairs Medical Center (VAMC) location.\n\nVAMC Providers and Staff Inclusion Criteria:\n\n1. Provider or staff member at one of the VAMC locations including physicians, nurse practitioners, physicians' assistants, and nurses caring for Veterans\n2. Providers or staff members having helped provide care for at least 5 Veterans with cancer in the previous 6 months at a VAMC location\n\nPatients Exclusion Criteria:\n\n1. Veterans who have not seen any providers in the VA within the past year\n2. Patients previously diagnosed with lung, prostate, breast, or colon cancer\n3. Pregnant patients\n\nVAMC Providers and Staff Exclusion Criteria:\n\n1\\. Providers or staff members who do not help treat Veterans with specified cancers in oncology at the VA","ALL","18 Years",{"count":56,"type":20},1800,[58],"NA","The objective of the pragmatic trial to test the effectiveness of an existing, ongoing clinical service, the VA National TeleOncology program (NTO), a multilevel telehealth population health management program. The primary aims are to study the intervention and determine its effectiveness on telehealth engagement, clinical quality, and healthcare cost outcomes across personal characteristics.",[61,62,63,64],"Lung Cancer Diagnosis","Colorectal Cancer (Diagnosis)","Prostate Cancer Diagnosis","Breast Cancer Diagnosis","2026-06-01",{"date":67,"type":38},"2026-06-03",{"date":69,"type":38},"2024-06-18",{"date":71,"type":20},"2027-07-31",{"name":73,"class":45},"NYU Langone Health",5,{"id":76,"slug":77,"hasResults":12,"nctId":78,"briefTitle":79,"officialTitle":80,"acronym":4,"eligibilityCriteria":81,"healthyVolunteers":12,"sex":82,"minAge":83,"maxAge":4,"enrollmentInfo":84,"targetDuration":4,"studyType":21,"phases":86,"briefSummary":88,"conditions":89,"keywords":4,"overallStatus":90,"whyStopped":4,"lastUpdateSubmitDate":91,"lastUpdatePostDateStruct":92,"startDateStruct":93,"completionDateStruct":94,"leadSponsor":96,"locationsCount":4},"100637123","phase-3-investigating-the-safety-and-diagnostic-performance-of-68ga-nym032-injection-petct-in-men-with-newly-diagnosed-prostate-cancer-100637123","NCT07615101","Investigating the Safety and Diagnostic Performance of 68Ga-NYM032 Injection PET\u002FCT in Men With Newly Diagnosed Prostate Cancer.","Open-label, Phase 3, Multi Center, Single-arm, Imaging Study Investigating the Safety and Diagnostic Performance of 68Ga-NYM032 Injection PET\u002FCT in Men With Newly Diagnosed Prostate Cancer.","Inclusion Criteria:\n\n1. Patient is male and aged \\>18 years old.\n2. Biopsy proven prostate adenocarcinoma.\n3. Patients electing to undergo Radical Prostatectomy (RP) with Pelvic lymph node dissection (PLND).\n4. ECOG performance status 0-2; expected survival ≥ 6 months.\n\n6\\. Ability to understand a written informed consent document, and the willingness to sign it.\n\nExclusion Criteria:\n\n* 1\\. Participants who have previously participated in other interventional clinical trials and are within five physical half-lives, or have received radionuclide agents previously with an interval of less than ten physical half-lives prior to study drug injection.\n\n  2\\. Participants administered any IV iodinated contrast medium within 24 hours, or any high density oral contrast medium (oral water contrast is acceptable) within 5 days, prior to study drug injection.\n\n  3\\. Known hypersensitivity to the active ingredient or excipients of the study drug.\n\n  4\\. Participants not capable of getting PET study , or inability to lay still for the duration of the exam.\n\n  5\\. Any medical condition or circumstance that, in the investigator's judgment, may compromise study safety or patient compliance.","FEMALE","18 Days",{"count":85,"type":20},365,[87],"PHASE3","The investigators are imaging patients with newly diagnosed prostate cancer using a new Positron Emission Tomography (PET) imaging agent (68Ga-NYM032) in order to evaluate the safety and diagnostic performance.",[26],"NOT_YET_RECRUITING","2026-05-28",{"date":65,"type":38},{"date":65,"type":20},{"date":95,"type":20},"2027-07-30",{"name":97,"class":98},"Norroy Bioscience Co., LTD","INDUSTRY",{"id":100,"slug":101,"hasResults":12,"nctId":102,"briefTitle":103,"officialTitle":104,"acronym":105,"eligibilityCriteria":106,"healthyVolunteers":107,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":108,"targetDuration":4,"studyType":21,"phases":110,"briefSummary":111,"conditions":112,"keywords":113,"overallStatus":90,"whyStopped":4,"lastUpdateSubmitDate":118,"lastUpdatePostDateStruct":119,"startDateStruct":121,"completionDateStruct":122,"leadSponsor":124,"locationsCount":4},"100637714","early-diagnosis-of-prostate-cancer-for-black-men-100637714","NCT07620717","Early Diagnosis of PROstate CANcer for Black Men","Encouraging Early Diagnosis of PROstate CANcer for Black Men (the PROCAN-B+ Study): A Mixed-Methods, Two-Arm, Multi-Centre Randomised Controlled Trial of a Co-Produced, Peer-Led Intervention","PROCAN-B+","Inclusion Criteria:\n\n* Black men aged 45 years or over, living in North East England, North Yorkshire, London or Scotland\n\nExclusion Criteria:\n\n* Men from other ethnicities\n* Black men aged less than 45 years\n* Black men with previous prostate cancer diagnosis",true,{"count":109,"type":20},300,[58],"PROCAN-B+ is a mixed-methods, two-arm, multi-centre randomised controlled trial evaluating a co-designed, peer-led intervention to encourage informed help-seeking and engagement with prostate cancer health checks and Prostate Specific Antigen (PSA) testing among Black men aged 45 years and over with no history of prostate cancer.\n\nThe study will recruit 300 participants across three UK sites: North East England including Leeds, Scotland, and London. Following eligibility screening and baseline data collection, participants will be individually randomised in a 1:1 ratio to either the intervention or wait-list control arm by an independent clinical trials unit. Participants allocated to the intervention arm will attend a two-hour co-designed community-based workshop shortly after randomisation, while participants allocated to the control arm will be invited to attend the workshop following the 6-month follow-up period. Due to the nature of the intervention, participants and researchers will not be blinded to allocation.\n\nThe intervention was co-designed in partnership with Black men and includes peer-led discussions on barriers to early diagnosis of prostate cancer, health education delivered by a Black GP, activities aimed at supporting effective communication with healthcare professionals, and video testimonials from prostate cancer survivors, women, and religious leaders.\n\nPrimary outcomes include self-reported discussions with GPs relating to prostate cancer risk, self-reported PSA testing, and GP-recorded PSA testing where participant consent is provided. Secondary outcomes include knowledge of prostate cancer, attitudes towards prostate cancer health checks and PSA testing, and help-seeking behaviours. Data will be collected at baseline, 3-month, and 6-month follow-up.\n\nA qualitative process evaluation involving participants, peer facilitators, and professionals will explore experiences and acceptability of the intervention and inform future implementation and scale-up.",[26],[114,115,116,117],"Prostate Cancer","Early diagnosis","Black men","Participatory research","2026-05-26",{"date":120,"type":38},"2026-06-02",{"date":65,"type":20},{"date":123,"type":20},"2028-08-31",{"name":125,"class":45},"University of Sunderland",{"id":127,"slug":128,"hasResults":12,"nctId":129,"briefTitle":130,"officialTitle":131,"acronym":4,"eligibilityCriteria":132,"healthyVolunteers":12,"sex":16,"minAge":133,"maxAge":134,"enrollmentInfo":135,"targetDuration":137,"studyType":138,"phases":4,"briefSummary":139,"conditions":140,"keywords":142,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":152,"lastUpdatePostDateStruct":153,"startDateStruct":155,"completionDateStruct":157,"leadSponsor":159,"locationsCount":46},"100639284","multimodal-imaging-and-digital-pathology-for-prostate-cancer-prediction-100639284","NCT07614256","Multimodal Imaging and Digital Pathology for Prostate Cancer Prediction","A Multicenter Study of a Deep Learning Model Based on Spatial Registration of Multimodal Imaging and Digital Pathology for Predicting Clinically Significant Prostate Cancer","Inclusion Criteria:\n\n1. Subjects who are scheduled to undergo or have undergone prostate biopsy or radical prostatectomy.\n2. Subjects who have completed standard-of-care preoperative multiparametric MRI (mpMRI) and transrectal ultrasound (TRUS) examinations.\n3. Subjects with complete pathological diagnosis results available.\n4. Age between 40 and 90 years.\n5. Able and willing to provide written informed consent (for prospective cohort participants only).\n\nExclusion Criteria:\n\n1. Prior history of pelvic radiation therapy or radical prostatectomy.\n2. Incomplete or poor-quality mpMRI or TRUS images (e.g., motion artifacts, insufficient sequences).\n3. Concurrent other primary malignant tumors.\n4. Severe systemic diseases that may affect the evaluation of the prostate.\n5. Subjects with incomplete clinical or pathological data.\n6. Contraindications to MRI examination (e.g., incompatible metallic implants, severe claustrophobia).","40 Years","90 Years",{"count":136,"type":20},3000,"12 Years","OBSERVATIONAL","This is a multicenter observational study. A deep learning model integrated with multimodal imaging and digital pathology spatial registration is built based on preoperative multiparametric magnetic resonance imaging, transrectal ultrasound and postoperative digital pathological whole slide images. The study is designed to achieve accurate prediction of clinically significant prostate cancer and non-invasive risk stratification. Unnecessary prostate biopsy and overdiagnosis can be reduced to support the optimization of clinical diagnosis and treatment strategies.",[26,141],"Clinically Significant Prostate Cancer",[143,144,145,146,147,148,149,150,151],"Prostate cancer","Clinically significant prostate cancer","Multiparametric Magnetic Resonance Imaging","Transrectal ultrasound","Digital pathology","Deep learning","Artificial intelligence","Spatial registration","Risk stratification","2026-05-25",{"date":154,"type":38},"2026-05-29",{"date":156,"type":38},"2025-05-30",{"date":158,"type":20},"2030-12-31",{"name":160,"class":45},"Guangxi Medical University",{"id":162,"slug":163,"hasResults":12,"nctId":164,"briefTitle":165,"officialTitle":166,"acronym":167,"eligibilityCriteria":168,"healthyVolunteers":12,"sex":16,"minAge":133,"maxAge":4,"enrollmentInfo":169,"targetDuration":4,"studyType":21,"phases":171,"briefSummary":172,"conditions":173,"keywords":176,"overallStatus":90,"whyStopped":4,"lastUpdateSubmitDate":185,"lastUpdatePostDateStruct":186,"startDateStruct":188,"completionDateStruct":190,"leadSponsor":192,"locationsCount":46},"100638672","tens-as-an-adjunct-to-local-anaesthesia-during-transperineal-prostate-biopsy-a-randomized-sham-controlled-trial-100638672","NCT07578324","TENS as an Adjunct to Local Anaesthesia During Transperineal Prostate Biopsy: A Randomized Sham-Controlled Trial","Transcutaneous Electrical Nerve Stimulation as an Adjunct to Local Anaesthesia During Transperineal MRI-Ultrasound Fusion-Guided Prostate Biopsy: A Randomized Triple-Blind Sham-Controlled Trial","TENS 2","Inclusion Criteria:\n\n* Male patients aged 40 years or older\n* Indication for prostate biopsy: elevated serum PSA (as per institutional protocol and EAU guidelines) or abnormal digital rectal examination (DRE)\n* Suspicious lesion on multiparametric MRI classified as PI-RADS score 3 or higher (version 2.1)\n* Scheduled for transperineal MRI-ultrasound fusion-guided prostate biopsy under local anaesthesia\n* Ability to provide written informed consent\n\nExclusion Criteria:\n\n* Prior treatment for prostate cancer (surgical, radiotherapy, hormonal or focal therapy)\n* Contraindications to TENS: cutaneous damage or dermatologic conditions at electrode application sites; cardiac pacemaker or implantable cardioverter-defibrillator (ICD); uncontrolled cardiac arrhythmia or congestive heart failure; history of epilepsy or seizure disorder; metallic implants near the stimulation site; malignancy at or near the stimulation site\n* Contraindications to transperineal biopsy: active urinary tract infection; bleeding disorder or ongoing anticoagulation not amendable to bridging; anatomical abnormalities preventing safe prostatic access\n* Known allergy or intolerance to local anaesthetic agents or biopsy-related materials\n* Severe comorbidities or unstable medical condition compromising procedural safety\n* Inability to complete questionnaires\n* Participation in another interventional clinical trial within 30 days prior to enrolment",{"count":170,"type":20},140,[58],"Transperineal prostate biopsy is a safe and effective method of diagnosing prostate cancer. When performed under local anaesthesia in an outpatient setting, it can cause significant pain, particularly during the periprostatic nerve block - the injection of local anaesthetic around the prostate. Better pain management during this procedure may improve patient comfort and encourage wider use of the transperineal approach.\n\nTranscutaneous electrical nerve stimulation (TENS) is a non-invasive, low-cost method of pain relief that works by delivering mild electrical impulses through the skin. A preceding pilot study at our centre (n=84) found that TENS used alongside local anaesthesia was associated with significantly lower pain scores during periprostatic nerve block and biopsy sampling, with no device-related complications.\n\nThis study aims to confirm these findings in a larger, formally powered, triple-blind, randomized controlled trial. Participants will be randomly assigned to receive either active TENS or sham TENS (electrodes applied but no electrical current delivered) in addition to standard local anaesthesia. Neither the participant, the operating urologist, nor the nurse recording pain scores will know which group the participant is in.\n\nPain intensity will be assessed at four stages of the procedure using a 0-10 numeric rating scale. Participants will be followed up at 30 days after the biopsy.",[26,174,175],"Prostate Biopsy","Pain, Procedural",[177,178,179,180,181,182,183,184],"Transcutaneous Electrical Nerve Stimulation","TENS","Transperineal Prostate Biopsy","Local Anaesthesia","Periprostatic Nerve Block","Pain Management","MRI-Ultrasound Fusion Biopsy","Randomized Controlled Trial","2026-05-05",{"date":187,"type":38},"2026-05-11",{"date":189,"type":20},"2026-06",{"date":191,"type":20},"2027-02",{"name":193,"class":45},"Medical University of Gdansk",{"id":195,"slug":196,"hasResults":12,"nctId":197,"briefTitle":198,"officialTitle":199,"acronym":4,"eligibilityCriteria":200,"healthyVolunteers":12,"sex":16,"minAge":133,"maxAge":201,"enrollmentInfo":202,"targetDuration":4,"studyType":21,"phases":204,"briefSummary":205,"conditions":206,"keywords":208,"overallStatus":90,"whyStopped":4,"lastUpdateSubmitDate":212,"lastUpdatePostDateStruct":213,"startDateStruct":214,"completionDateStruct":215,"leadSponsor":217,"locationsCount":46},"100636541","improving-cryoablation-efficacy-with-barrigel-rectal-spacing-ice-barr-100636541","NCT07567027","Improving Cryoablation Efficacy With BARRigel Rectal Spacing (ICE-BARR)","Improving Cryoablation Efficacy With BARRigel Rectal Spacing (ICE-BARR) Trial","Inclusion Criteria:\n\n* Male patients aged 40-95 years.\n* Biopsy-confirmed localized prostate cancer (Grade Group ≥ 2). Salvage cryoablation cases may be included.\n* Unifocal disease visible on multiparametric MRI (mpMRI) and amenable to focal or whole gland cryoablation.\n* Prostate-specific antigen (PSA) \\\u003C 20 ng\u002Fml.\n* No metastatic disease on Prostate-Specific Membrane Antigen (PSMA) PET\u002FCT, when recommended per National Comprehensive Cancer Network (NCCN) guidelines.\n* Eligible for and consenting to transperineal cryoablation under anesthesia.\n* Willingness to comply with post-procedure follow-up, including PSA testing and imaging.\n* Cryoablation which requires treatment of the posterior prostate as per clinician judgement.\n\nExclusion Criteria:\n\n* Evidence of metastatic disease.\n* Prior radiation therapy to the area of the prostate.\n* Active rectal or urinary tract infection.\n* Known allergy to hyaluronic acid products or contrast agents.\n* Inability to tolerate MRI.\n* Inability or unwillingness to comply with study follow-up.","95 Years",{"count":203,"type":20},20,[58],"The purpose of this study is to evaluate the feasibility, safety, and potential protective benefit of Barrigel, a hyaluronic acid-based rectal spacer, in patients undergoing prostate cryoablation for localized or recurrent prostate cancer. The primary aim is to assess Barrigel thermal stability during cryoablation.",[26,207],"Transperineal Cryoablation",[209,210,211],"cryoablation","prostate","Barrigel","2026-04-28",{"date":185,"type":38},{"date":65,"type":20},{"date":216,"type":20},"2028-06-01",{"name":73,"class":45},{"id":219,"slug":220,"hasResults":12,"nctId":221,"briefTitle":222,"officialTitle":223,"acronym":4,"eligibilityCriteria":224,"healthyVolunteers":12,"sex":16,"minAge":54,"maxAge":4,"enrollmentInfo":225,"targetDuration":4,"studyType":21,"phases":227,"briefSummary":228,"conditions":229,"keywords":230,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":234,"lastUpdatePostDateStruct":235,"startDateStruct":237,"completionDateStruct":239,"leadSponsor":241,"locationsCount":46},"100635939","theranostic-applications-of-radionuclides-in-prostate-cancer-100635939","NCT07559201","Theranostic Applications of Radionuclides in Prostate Cancer","ACP3 Targeted -PET\u002F CT in Prostate Cancer","Inclusion Criteria:\n\n* Adult patients (aged 18 years or older);\n* Patients with newly diagnosed, highly suspected recurrence or previously treated metastases of prostate cancer (supporting evidence may include MRI, CT, tumor markers, and pathology report);\n* Patients who had scheduled both standard-of-care imaging (PSMA\u002FFDG PET\u002FCT) and ACP3 PET\u002FCT scans;\n* Patients who were able to provide informed consent (signed by participant, parent or legal representative) and assent according to the guidelines of the Clinical Research Ethics Committee.\n\nExclusion Criteria:\n\n* The inability or unwillingness of the research participant or legal representative to provide written informed consent.",{"count":226,"type":20},100,[58],"The objective of the study is to construct a noninvasive approach ACP3 targeted PET\u002FCT to detect tumor lesions in patients with prostate cancer and to compare with PSMA\u002FFDG PET\u002FCT.",[26],[231,232,233],"prostate cancer","PET\u002FCT","ACP3","2026-04-23",{"date":236,"type":38},"2026-04-30",{"date":238,"type":38},"2026-01-01",{"date":240,"type":20},"2029-12-31",{"name":242,"class":45},"Guilin Medical University, China",{"id":244,"slug":245,"hasResults":12,"nctId":246,"briefTitle":247,"officialTitle":247,"acronym":4,"eligibilityCriteria":248,"healthyVolunteers":12,"sex":16,"minAge":249,"maxAge":134,"enrollmentInfo":250,"targetDuration":251,"studyType":138,"phases":4,"briefSummary":252,"conditions":253,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":254,"lastUpdatePostDateStruct":255,"startDateStruct":257,"completionDateStruct":259,"leadSponsor":261,"locationsCount":46},"100635407","the-enhancement-of-diagnostic-and-grading-efficacy-of-prostate-cancer-by-new-mri-sequences-a-prospective-observational-study-based-on-new-mri-sequences-in-a-single-center-100635407","NCT07552285","The Enhancement of Diagnostic and Grading Efficacy of Prostate Cancer by New MRI Sequences: A Prospective Observational Study Based on New MRI Sequences in a Single Center","Inclusion Criteria:\n\n1. Patients with a high clinical suspicion of prostate cancer and elevated tPSA levels;\n2. Patients with no prior history of other tumors;\n3. Patients with no contraindications to MRI, including claustrophobia, presence of pacemakers, cardiac stents, or metal implants such as screws and plates.\n\nExclusion Criteria:\n\n1. The patient has a history of malignant tumors and has received corresponding treatment;\n2. Prior to the MRI examination, the patient has undergone treatment for prostate cancer, including endocrine therapy, radiotherapy, etc.;\n3. Patients who have previously undergone radical prostatectomy for prostate cancer.","20 Years",{"count":109,"type":20},"4 Months","The goal of this clinical trial aims to explore the diagnostic efficacy and grading of prostate cancer by a novel MRI sequences such as MAGiC，OGSE,CEST,IVIM,etc.The main question it aims to answer is:\n\nCan the novel non-contrast multiparametric MRI imaging improve the accuracy of diagnosis and grading of prostate cancer? For patients with clinical suspicion of prostate cancer, both conventional and new sequences magnetic resonance scans are conducted, with surgical or biopsy pathological results serving as the gold standard.",[114,26],"2026-04-20",{"date":256,"type":38},"2026-04-27",{"date":258,"type":38},"2025-05-01",{"date":260,"type":20},"2027-06-01",{"name":262,"class":45},"The First Affiliated Hospital of Soochow University",{"id":264,"slug":265,"hasResults":12,"nctId":266,"briefTitle":267,"officialTitle":268,"acronym":269,"eligibilityCriteria":270,"healthyVolunteers":12,"sex":16,"minAge":54,"maxAge":4,"enrollmentInfo":271,"targetDuration":4,"studyType":138,"phases":4,"briefSummary":273,"conditions":274,"keywords":281,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":254,"lastUpdatePostDateStruct":283,"startDateStruct":284,"completionDateStruct":286,"leadSponsor":288,"locationsCount":290},"100635520","plasma-exosomal-rna-signature-for-prostate-cancer-bone-metastasis-100635520","NCT07553754","Plasma Exosomal RNA Signature for Prostate Cancer Bone Metastasis","Plasma Exosomal RNA Signature for Predicting PSMA PET-Defined Bone Metastasis in Prostate Cancer: A Prospective, Multicenter Discovery, Development, and Validation Study","EXO-MET","Inclusion Criteria\n\n1. Patients with histologically confirmed prostate cancer who are scheduled to undergo baseline PSMA PET imaging.\n2. Patients who undergo PSMA PET imaging prior to any prostate cancer-related treatment (including androgen deprivation therapy, radiotherapy, or surgery).\n3. Patients who provide blood samples for plasma exosomal RNA analysis collected prior to any treatment AND prior to prostate biopsy (if applicable).\n\n   Whole blood samples (approximately 10 mL) will be collected in EDTA tubes at this specified time point. Samples will be processed within 2 hours to obtain plasma and stored at -80°C until analysis.This timing ensures circulating exosomal RNA profiles reflect tumor biology without biopsy-induced contamination.\n4. Patients who are willing to undergo prostate biopsy if clinically indicated (biopsy performed after blood collection).\n5. Patients who provide written informed consent to participate in the study.\n6. Age ≥18 years.\n\nExclusion Criteria\n\n1. Patients who have received any prior prostate cancer-related treatment before the baseline PSMA PET scan (including hormonal therapy, radiotherapy, chemotherapy, or surgery).\n2. Patients whose blood samples were collected after prostate biopsy.\n3. Patients with a history of other active malignancies within the past two years (excluding non-melanoma skin cancer).\n4. Patients with inadequate blood sample quality or quantity for exosomal RNA extraction and analysis (e.g., hemolysis, insufficient volume \\\u003C8 mL).\n5. Patients with severe comorbidities or conditions that, in the judgment of the investigator, could interfere with study compliance or pose significant risk.",{"count":272,"type":20},1000,"Brief Summary:\n\nThis prospective, multicenter study aims to discover, develop, and validate a plasma exosomal RNA-based signature as a rule-out test for predicting bone metastasis in prostate cancer, using baseline treatment-naïve PSMA PET as the gold standard. The study is designed in four sequential phases:\n\nPhase 1 (Discovery, n=250): High-throughput sequencing of plasma exosomal RNAs to identify differentially expressed candidate RNAs.\n\nPhase 2 (Model Development, n=300): Digital droplet PCR (ddPCR) analysis of candidates in an independent cohort to construct and lock the final multi-RNA predictive signature using appropriate machine learning methods.\n\nPhase 3 (Internal Validation, n=300): Independent validation of the locked signature in a consecutive cohort reflecting natural disease prevalence.\n\nPhase 4 (External Validation, n=150): Final independent validation in a multi-center cohort enriched for bone metastasis.\n\nPrimary Outcome:\n\nTo evaluate the diagnostic performance of the signature as a rule-out test for PSMA PET-defined bone metastasis. The primary performance metrics are:\n\nSensitivity, with a prespecified target of ≥95% (to ensure minimal false negatives).\n\nSpecificity at the threshold that achieves the ≥95% sensitivity. A specificity of ≥30% will be considered supportive of clinical utility. A specificity of ≥30% (or a lower bound of the 95% confidence interval exceeding 20%) will be considered supportive of clinical utility.\n\nNeed:\n\nCurrent biomarkers lack sensitivity and specificity for early detection of bone metastasis. More importantly, existing tools lack adequate negative predictive value to safely rule out bone metastasis in low-risk patients, leading to over-imaging or delayed detection. There is an urgent need for a non-invasive rule-out test to safely defer PSMA PET\u002FCT in very-low-risk patients. Plasma exosomal RNAs offer a promising liquid biopsy approach, but prospective multicenter studies with rigorous validation are lacking.\n\nSecondary Outcomes:\n\n1. Secondary metrics include negative predictive value (NPV), positive predictive value (PPV), area under the ROC curve (AUC), calibration, and decision curve analysis.\n2. Correlation between exosomal RNA levels and number of bone metastatic lesions (PSMA PET).\n3. Association with PSA, PSMA PET SUVmax, and MRI findings.\n4. Tissue-plasma correlation to confirm tumor origin (exploratory).\n5. Mechanistic exploration of key candidates via in vitro\u002Fin vivo assays (exploratory).\n6. Subgroup analyses by hormone sensitivity, metastatic pattern, Gleason grade (exploratory).\n\nInclusion Criteria:\n\n1. Histologically confirmed prostate cancer scheduled for baseline PSMA PET.\n2. PSMA PET performed prior to any prostate cancer-related treatment.\n3. Blood samples collected prior to any treatment AND prior to prostate biopsy.\n4. Willing to undergo prostate biopsy if clinically indicated (after blood collection).\n5. Written informed consent.\n6. Age ≥18 years.\n\nExclusion Criteria:\n\n1. Any prior prostate cancer treatment before baseline PSMA PET.\n2. Blood samples collected after prostate biopsy.\n3. Other active malignancy within past two years (excluding non-melanoma skin cancer).\n4. Inadequate blood sample quality or quantity.\n5. Severe comorbidities interfering with study conduct.",[26,275,276,277,278,279,280],"Bone Metastasis","PSMA PET","Liquid Biopsy","Exosomal RNA","Biomarker Discovery and Validation","Treament-naive",[114,275,276,277,278,282],"Predictive Signature",{"date":212,"type":38},{"date":285,"type":38},"2026-03-12",{"date":287,"type":20},"2027-12-31",{"name":289,"class":45},"Xijing Hospital",9,{"id":292,"slug":293,"hasResults":12,"nctId":294,"briefTitle":295,"officialTitle":295,"acronym":296,"eligibilityCriteria":297,"healthyVolunteers":12,"sex":16,"minAge":298,"maxAge":4,"enrollmentInfo":299,"targetDuration":4,"studyType":138,"phases":4,"briefSummary":301,"conditions":302,"keywords":307,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":322,"lastUpdatePostDateStruct":323,"startDateStruct":325,"completionDateStruct":327,"leadSponsor":329,"locationsCount":331},"100630230","study-of-the-epidemiological-clinical-diagnostic-and-therapeutic-characteristics-of-prostate-cancers-in-algeria-100630230","NCT07484971","Study of the Epidemiological, Clinical, Diagnostic, and Therapeutic Characteristics of Prostate Cancers in Algeria","CLIQQC","Inclusion Criteria:\n\n* Patients aged 19 years and older.\n* Diagnosis of prostate cancer confirmed histologically and\u002For biologically.\n* Patients followed in the participating oncology departments.\n* Written informed consent obtained.\n\nNon Inclusion Criteria:\n\n* Histological types other than carcinoma\n* Secondary tumors\n* Participation in an interventional study","19 Years",{"count":300,"type":20},2000,"The goal of this observational study is to describe the demographic, epidemiological, clinical, and outcome characteristics of patients with prostate cancer.\n\nIt also aims to analyze the diagnostic approaches and management strategies used in the care of these patients in Algeria.",[114,26,303,304,305,306],"Prostate Cancer (Post Prostatectomy)","Prostate Cancer Patients Treated by Radiotherapy","Prostate Cancer Metastatic","Prostate Cancer (Adenocarcinoma)",[308,309,114,310,311,312,313,314,315,316,317,318,319,320,321],"oncology","patient outcome","Prostate Cancer in Algerian patients","Observational Study","Retrospective data","Treatment strategies","Diagnostic approaches","Clinical characteristics","Epidemiological data","Demographic data","Cross-sectional study","Real-world data","Algeria","Algerian Study","2026-04-14",{"date":324,"type":38},"2026-04-17",{"date":326,"type":38},"2025-07-21",{"date":328,"type":20},"2026-07-21",{"name":330,"class":45},"Société Algérienne de Formation et Recherche en Oncologie",24,{"id":333,"slug":334,"hasResults":12,"nctId":335,"briefTitle":336,"officialTitle":336,"acronym":337,"eligibilityCriteria":338,"healthyVolunteers":12,"sex":16,"minAge":54,"maxAge":4,"enrollmentInfo":339,"targetDuration":341,"studyType":138,"phases":4,"briefSummary":342,"conditions":343,"keywords":346,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":350,"lastUpdatePostDateStruct":351,"startDateStruct":353,"completionDateStruct":355,"leadSponsor":357,"locationsCount":46},"100632684","prognostic-value-of-early-postoperative-prostate-specific-antigen-for-oncological-outcomes-after-radical-prostatectomy-100632684","NCT07516886","Prognostic Value of Early Postoperative Prostate-Specific Antigen for Oncological Outcomes After Radical Prostatectomy","PPSARP","Inclusion Criteria:\n\n* Patient is an adult biological male.\n* Patient has morphologically confirmed and untreated prostate cancer.\n* Patient who will be treated with open, laparoscopic or robot-assisted laparoscopic radical prostatectomy.\n* Patient is informed about this observational study and has signed the informed consent form.\n\nExclusion Criteria:\n\n* Patient has radiologically of morphologically confirmed prostate cancer metastases before the operation.\n* Patient received neoadjuvant prostate cancer treatment.\n* Patient is set to receive adjuvant treatment.\n* Patient has any contraindications for the operation.",{"count":340,"type":20},500,"10 Years","This prospective observational study aims to evaluate the prognostic significance of early postoperative prostate-specific antigen (PSA) levels in patients undergoing radical prostatectomy for prostate cancer.\n\nNo investigational interventions will be performed. All diagnostic procedures, follow-up assessments, and treatments will be conducted in accordance with standard clinical practice and established prostate cancer management guidelines. Participation in the study will not influence treatment decisions.",[303,306,26,344,345],"Prostate Specific Antigen","Radical Prostatectomy",[231,347,348,349],"persistent prostate-specific antigen","prostate-specific antigen","radical prostatectomy","2026-04-01",{"date":352,"type":38},"2026-04-08",{"date":354,"type":38},"2024-01-22",{"date":356,"type":20},"2039-07",{"name":358,"class":45},"Lithuanian University of Health Sciences",{"id":360,"slug":361,"hasResults":12,"nctId":362,"briefTitle":363,"officialTitle":364,"acronym":365,"eligibilityCriteria":366,"healthyVolunteers":12,"sex":16,"minAge":54,"maxAge":4,"enrollmentInfo":367,"targetDuration":4,"studyType":21,"phases":369,"briefSummary":371,"conditions":372,"keywords":376,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":378,"lastUpdatePostDateStruct":379,"startDateStruct":380,"completionDateStruct":382,"leadSponsor":384,"locationsCount":46},"100597119","phase-1-comparison-of-177lu-psma-617-and-225ac-psma-617-100597119","NCT07054346","Comparison of 177Lu-PSMA-617 and 225Ac-PSMA-617","Comparison of 177Lu-PSMA-617 and 225Ac-PSMA-617 in a Prostatectomy Model (LUTACT Trial)","LUTACT","Inclusion Criteria:\n\n1. Histologically confirmed prostate adenocarcinoma.\n2. Willing to undergo prostatectomy with or without lymph node dissection, and candidate for prostatectomy as determined by urologic oncology.\n3. High-risk disease as defined as meeting 1 or more of the 3 following criteria:\n\n   1. Gleason score of 4+5 disease or higher.\n   2. Pelvic nodal metastases on PSMA PET.\n   3. Extracapsular extension or seminal vesicle invasion on MRI.\n4. No evidence of distant metastatic disease as determined by PSMA PET. Nodal disease below the iliac bifurcation (clinical stage N1) is allowed.\n5. Maximum Standardized Uptake Value (SUVmax) in the primary tumor greater than 10 on PSMA PET using Gallium-68 (68Ga)-PSMA-11 or piflufolastat F 18 (18F-DCFPyL).\n6. Target tumor in the prostate measuring greater than 1.5 cm on MRI.\n7. Age ≥18 years.\n8. Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 (Karnofsky ≥ 60%),\n9. Demonstrates adequate organ function as defined below:\n\n   1. Platelets ≥100,000\u002FmcL, independent of transfusions or growth factors within 3 months of treatment start.\n   2. Hemoglobin ≥10 g\u002FdL, independent of transfusions or growth factors within 3 months of treatment start.\n   3. Absolute Neutrophil Count (ANC) ≥1,500\u002Fmicroliter (mcL).\n   4. Creatinine clearance Glomerular filtration rate (GFR) ≥ 60 mL\u002Fmin\u002F1.73 m\\^2 , calculated using the Cockcroft-Gault equation.\n   5. Albumin ≥2.5 g\u002FdL.\n   6. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≤3.0 x ULN.\n   7. Total bilirubin (TBIL) ≤2 x the institutional upper limit of normal (ULN). For participants with known Gilbert's Syndrome ≤3 x ULN is permitted.\n10. Ability to understand and the willingness to sign a written informed consent document.\n11. Participants must provide consent to comply to recommended radioprotection precautions during study.\n12. Participants must use adequate contraception and not donate sperm while on study drug and for at least 14 weeks after the last study treatment.\n\nExclusion Criteria:\n\n1. Has received prior prostate cancer therapy.\n\n   a. Prior 5-alpha reductase inhibitors (e.g. finasteride, dutasteride) allowed if discontinued at least 3 weeks prior to treatment start.\n2. Has participated in a study of an investigational therapeutic product and received study treatment or used an investigational device within four weeks of the first dose of treatment.\n3. Dry mouth that impacts the eating of food (i. e. requiring mouthwash prior to eating).\n4. Concurrent serious (as determined by the principal investigator) medical conditions including but not limited to New York Heart Association class III or IV congestive heart failure, history of congenital prolonged QT syndrome, uncontrolled infection, known active hepatitis B or C or other significant co-morbid conditions that in the opinion of the investigator would impair study participation or cooperation.\n5. Diagnosed with other malignancies that are expected to alter life expectancy or may interfere with disease assessment. However, participants with a prior history of malignancy that has been adequately treated and who have been disease free, treatment free for more than 3 years prior to randomization, or participants with adequately treated non-melanoma skin cancer, superficial bladder cancer are eligible.\n6. Individuals with a prior or concurrent malignancy whose natural history or treatment has the potential to interfere with the safety or efficacy assessment of the investigational regimen.\n7. Prior external beam radiation therapy (EBRT) to the prostate or prostate bed.\n\nAdditional exclusion criteria applicable only to participants undergoing intraarterial administration of PSMA RLT:\n\n1. Severe allergy to iodinated contrast.\n2. Severe atherosclerosis from prior CT imaging study, or greater than 10 pack-year smoking history if no prior imaging available.",{"count":368,"type":20},45,[370],"PHASE1","There is evidence that Actinium-225 Prostate-Specific Membrane Antigen (225Ac-PSMA) has a potentially higher level of efficacy than 177 Lutetium Prostate-Specific Membrane Antigen (177Lu-PSMA) as a radioligand therapy. This single center, pilot study will compare differences in the mechanisms of actinium-225 and lutetium-177 radioligand therapies (RLT) in participants with high or very high risk localized or locoregional prostate cancer planning on undergoing a prostatectomy.",[114,26,373,374,375],"High-risk Prostate Cancer","Localized Prostate Carcinoma","Very High Risk Prostate Carcinoma",[377],"Radioligand Therapy","2026-03-26",{"date":350,"type":38},{"date":381,"type":38},"2025-07-08",{"date":383,"type":20},"2028-04-30",{"name":385,"class":45},"Thomas Hope",{"id":387,"slug":388,"hasResults":12,"nctId":389,"briefTitle":390,"officialTitle":391,"acronym":4,"eligibilityCriteria":392,"healthyVolunteers":12,"sex":16,"minAge":133,"maxAge":4,"enrollmentInfo":393,"targetDuration":4,"studyType":138,"phases":4,"briefSummary":394,"conditions":395,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":396,"lastUpdatePostDateStruct":397,"startDateStruct":399,"completionDateStruct":401,"leadSponsor":403,"locationsCount":46},"100604031","validation-of-a-platelet-proteomic-assay-for-diagnosing-and-monitoring-prostate-cancer-100604031","NCT07144228","Validation of a Platelet Proteomic Assay for Diagnosing and Monitoring Prostate Cancer","Validation of a Platelet Proteomic Assay for Diagnosing and Monitoring Prostate Cancer: A Prospective Study.","Eligibility criteria\n\n* Patients ≥ 40 years of age\n* All patients with suspicion of PCa\n\nMen ≥ 40 years of age attending Duke Health\u002FUrology with suspicion of prostate cancer (Primary disease) will be approached to consent for the study. Upon consent, samples will be obtained alone, during repeat PSA\u002Fother biomarkers testing, or during imaging at Duke Lab.\n\nExclusion criteria\n\n* Men who have previously undergone treatment for prostate cancer.\n* Men with prior diagnosis of prostate cancer.\n* Men with severe, irreversible coagulopathy.\n* Men on anticoagulant therapies or those who have taken antiplatelet agents such as aspirin, NSAIDs (ibuprofen, entrophen, naproxen, diclofenac etc), clopidrogel, prasugrel, ticagrelor, or dipyridamole in the 7 days preceding blood collection.",{"count":109,"type":20},"This is a single center study evaluating whether a new blood test based on platelet proteins rather than plasma proteins can improve detection of prostate cancer and evaluate the degree of serious disease. Currently, doctors rely on multiple tests such as PSA, MRI scans and biopsies to do the same evaluation. Researchers are trying to see if HeLP™ can be a safe and accurate alternative.\n\nThe study is inviting men who are being seen for suspicion of prostate cancer (based on symptoms or previous lab results). If they agree to be in the study, the research team will take a sample of their blood at the time they are getting a repeat PSA test or having Imaging. The research test does not affect the care they are already receiving and takes 3 extra tubes of blood (\\~3 tbsp).\n\nThe research team is aiming to include 300 participants total. They believe 278 people are needed to confidently compare results between people with and without prostate cancer.\n\nThey will do an interim analysis halfway through the study, once samples from 150 subjects have been collected.\n\nThe research is considered low risk-no more uncomfortable or dangerous than a blood draw. There is a risk of loss of privacy, but researchers are taking strong steps to protect privileged information. That includes proper data handling, secure, storage, and making sure the study team is trained in research ethics.",[26],"2026-03-17",{"date":398,"type":38},"2026-03-19",{"date":400,"type":38},"2026-03-11",{"date":402,"type":20},"2028-09-30",{"name":404,"class":45},"Duke University",{"id":406,"slug":407,"hasResults":12,"nctId":408,"briefTitle":409,"officialTitle":410,"acronym":411,"eligibilityCriteria":412,"healthyVolunteers":12,"sex":16,"minAge":249,"maxAge":4,"enrollmentInfo":413,"targetDuration":4,"studyType":21,"phases":415,"briefSummary":416,"conditions":417,"keywords":418,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":424,"lastUpdatePostDateStruct":425,"startDateStruct":426,"completionDateStruct":428,"leadSponsor":429,"locationsCount":46},"100623596","insight-pca-mri--and-phi-guided-risk-adapted-strategy-for-prostate-cancer-diagnosis-100623596","NCT07398690","INSIGHT-PCa: MRI- and PHI-Guided Risk-Adapted Strategy for Prostate Cancer Diagnosis","Integrated Noninvasive Strategy Guided by Multiparametric MRI and the Prostate Health Index for Risk-Adapted Detection of Clinically Significant Prostate Cancer: A Multicenter Randomized Controlled Trial (INSIGHT-PCa Study)","INSIGHT-PCa","Inclusion Criteria:\n\n* Male, aged 20 years or older\n* Serum PSA ≥3.0 ng\u002FmL and ≤20.0 ng\u002FmL and\u002For abnormal digital rectal -examination\n* Biopsy-naïve\n* Clinical stage ≤T2 disease\n* Ability to provide written informed consent\n\nExclusion Criteria:\n\n* Previous prostate biopsy or prostate cancer treatment\n* Use of 5-alpha reductase inhibitors within 6 months\n* Acute prostatitis or urinary tract infection within 3 months\n* Contraindications to MRI\n* Contraindications to prostate biopsy",{"count":414,"type":20},1432,[58],"Prostate cancer diagnosis based on systematic or MRI-targeted biopsy is associated with substantial overdiagnosis and unnecessary invasive procedures. Although multiparametric MRI improves detection of clinically significant prostate cancer, optimal criteria for biopsy omission-particularly in men with equivocal MRI findings-remain uncertain.\n\nThe INSIGHT-PCa study is a prospective, multicenter, randomized controlled trial designed to evaluate whether a risk-adapted diagnostic strategy integrating multiparametric MRI and the Prostate Health Index (PHI) can reduce unnecessary prostate biopsies without compromising detection of clinically significant prostate cancer.\n\nParticipants with suspected prostate cancer will be randomized to either a standard MRI-based diagnostic pathway or an optimized strategy in which biopsy decisions are guided by combined MRI findings and PHI density. The primary objective is to demonstrate non-inferiority in the detection of clinically significant prostate cancer while reducing biopsy utilization and biopsy-related adverse events.",[26,114],[143,419,420,421,422,423],"Multiparametric MRI","Prostate Health Index","Risk-adapted diagnosis","MRI-targeted biopsy","Biopsy reduction","2026-03-14",{"date":396,"type":38},{"date":427,"type":38},"2026-03-09",{"date":240,"type":20},{"name":430,"class":45},"In Gab Jeong, MD",{"id":432,"slug":433,"hasResults":12,"nctId":434,"briefTitle":435,"officialTitle":436,"acronym":4,"eligibilityCriteria":437,"healthyVolunteers":12,"sex":16,"minAge":54,"maxAge":438,"enrollmentInfo":439,"targetDuration":4,"studyType":21,"phases":441,"briefSummary":442,"conditions":443,"keywords":444,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":451,"lastUpdatePostDateStruct":452,"startDateStruct":453,"completionDateStruct":455,"leadSponsor":457,"locationsCount":46},"100628377","comparison-of-tbpb-and-tb6sb-for-prostate-cancer-diagnosis-100628377","NCT07460843","Comparison of TB+PB and TB+6SB for Prostate Cancer Diagnosis","A Head-to-Head Comparison of Targeted and Perilesional Biopsy Versus Combination of Sextant-Systematic Biopsy and Targeted Biopsy for Prostate Cancer Diagnosis: A Randomized Controlled Trial","Inclusion Criteria:\n\n* The age of the patient is between 18 and 85.\n* No previous biopsy.\n* Patients with single suspicious lesion, complete multiparametric magnetic resonance imaging (mpMRI) data, qualified image quality control, suspicious lesions, and Prostate Imaging Reporting and Data System version 2.1 (PI-RADS V2.1) of ≥ 3.\n* Patients were in accordance with the indication of prostate biopsy, including patients with suspicious prostate nodes found by digital rectal examination (DRE), the suspicious lesions found by transrectal ultrasound (TRUS) or MRI, total prostate-specific antigen (tPSA) \\>10ng\u002FmL, tPSA 4-10ng\u002FmL with free-to-total PSA ratio (f\u002FtPSA) \\\u003C0.16 or PSA density (PSAD) \\>0.15.\n* The prostate biopsy pathological results were complete. The time interval between prostate biopsy and prostate mpMRI examination should not exceed one month.\n* Patients with complete clinical information.\n\nExclusion Criteria:\n\n* The mpMRI data was unqualified or incomplete.\n* Patients had received radiotherapy, chemotherapy, androgen deprivation therapy, or surgery treatment before prostate mpMRI examination or prostate biopsy.\n* Patients with previous biopsy.\n* Patients with PI-RADS V2.1 of \\\u003C 3.\n* Patients were not in accordance with the indication of prostate biopsy.\n* The patient could not cooperate to complete the prostate biopsy.\n* The patients or their family members refused to participate in this study.\n* Patients with incomplete clinical information.","85 Years",{"count":440,"type":20},592,[58],"The goal of this randomized controlled trial (RCT) is to evaluate the diagnostic efficacy of two novel prostate biopsy schemes, including targeted and perilesional biopsy (TB+PB) and combination of sextant-systematic biopsy and targeted biopsy (TB+6SB).\n\nThe main questions it aims to answer are:\n\nDoes TB+PB promote the accurate diagnosis of clinically significant prostate cancer (csPCa)? Could TB+6SB achieve the non-inferior diagnostic efficacy compared to TB+PB scheme? What's the value of TB+6SB in improving the detection of prostate cancer in the negative prostate lobe (contralateral to the index lesion)? In the era of MRI-targeted biopsy (TB), when TB and PB is effectively conducted and allows confident detection of the ROI, do we still need to perform SB? Researchers will compare the cancer detection rates of TB+PB and TB+SB to explore the efficacy of different prostate biopsy schemes. They will evaluate the diagnostic profile of different prostate biopsy schemes through the spatial analysis of the prostate.\n\nParticipants will:\n\nReceive TB+PB or TB+6SB.",[26],[143,445,446,447,448,449,450],"Prostate biopsy","Targeted biopsy","Perilesional biopsy","Systematic biopsy","Diagnosis","RCT","2026-03-10",{"date":285,"type":38},{"date":454,"type":38},"2026-03-01",{"date":456,"type":20},"2027-03-31",{"name":458,"class":45},"Peking University First Hospital",{"id":460,"slug":461,"hasResults":12,"nctId":462,"briefTitle":463,"officialTitle":463,"acronym":464,"eligibilityCriteria":465,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":466,"enrollmentInfo":467,"targetDuration":4,"studyType":138,"phases":4,"briefSummary":469,"conditions":470,"keywords":472,"overallStatus":90,"whyStopped":4,"lastUpdateSubmitDate":476,"lastUpdatePostDateStruct":477,"startDateStruct":479,"completionDateStruct":481,"leadSponsor":482,"locationsCount":46},"100627897","a-prospective-clinical-trial-evaluating-prostest-a-blood-based-molecular-assay-for-risk-stratification-and-biopsy-decision-support-in-men-with-suspected-prostate-cancer-100627897","NCT07454603","A Prospective Clinical Trial Evaluating PROSTest, a Blood-Based Molecular Assay, for Risk Stratification and Biopsy Decision Support in Men With Suspected Prostate Cancer","PROSTest_STRAT","Inclusion Criteria:\n\n* elevated PSA and\u002For abnormal digital rectal examination\n\nExclusion Criteria:\n\n* Previous Prostate cancer diagnosis","80 Years",{"count":468,"type":20},1500,"This prospective observational study will enroll men referred for prostate biopsy due to elevated PSA and\u002For abnormal digital rectal examination, with or without pre-biopsy MRI. Peripheral blood will be collected prior to biopsy for PROSTest analysis. Biopsy histopathology will serve as the reference standard. PROSTest results will be analyzed blinded to pathology.",[114,471,26],"Urology",[473,474,475],"BIOPSY","MRI","PROSTATE CANCER","2026-03-02",{"date":478,"type":38},"2026-03-06",{"date":480,"type":20},"2026-03-15",{"date":260,"type":20},{"name":483,"class":98},"Wren Laboratories LLC",{"id":485,"slug":486,"hasResults":12,"nctId":487,"briefTitle":488,"officialTitle":489,"acronym":490,"eligibilityCriteria":491,"healthyVolunteers":12,"sex":16,"minAge":133,"maxAge":4,"enrollmentInfo":492,"targetDuration":4,"studyType":21,"phases":493,"briefSummary":494,"conditions":495,"keywords":496,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":507,"lastUpdatePostDateStruct":508,"startDateStruct":510,"completionDateStruct":512,"leadSponsor":514,"locationsCount":46},"100621357","evolution-of-lesions-in-repeated-biparametric-prostate-magnetic-resonance-imaging-100621357","NCT07369570","Evolution of Lesions in Repeated Biparametric Prostate Magnetic Resonance Imaging","A Prospective Study of the Evolution of Lesions in Repeated Biparametric Prostate Magnetic Resonance Imaging","REMRI","Inclusion Criteria:\n\n* Suspicion of a local prostate cancer\n* Patient have 1-2 PI-RADS 3-5 lesion\u002Flesions in biparametric prostate MRI, with no ISUP 2-5 prostate cancer in an initial systematic or lesion-targeted (at least two biopsy cores per lesion) biopsy\n* Prostate biopsies can be taken via transrectal approach in an outpatient clinic\n* An estimated life expentancy exceeding 10 years\n* The patient is cooperative, fluent in Finnish and understands the significance of the study\n* The patient signs an informed consent form approved by the ethics committee.\n\nExclusion Criteria:\n\n* The patient had undergone prostate biopsies prior to the biopsies that led to recruitment for the current study.\n* The physician's suspicion of a locally advanced or a high risk prostate cancer. Absolute exclusion criteria are PSA \\>20 ng\u002Fml or T4 staged prostate finding MRI or clinical examination\n* Seriuos infectious or non-infectious complication after initial biopsy\n* Deep immunosuppression due to organ transplant, hematologic disease, or related causes.\n* Any treatment given for prostate cancer diagnosed in initial biopsy\n* Hip prosthesis or any other object in the pelvic area that affects high-quality MRI\n* Claustrophobia or other absolute or relative contraindication for high-quality MRI",{"count":226,"type":20},[58],"The goal of this clinical trial is to prospectively investigate the evolution of lesions in biparametric magnetic resonance imaging (bpMRI) of the prostate in men with no clinically significant prostate cancer (csPCa) in their initial biopsy. The main questions it aims to answer are:\n\nDoes lesion progression in bpMRI predict a diagnosis of csPCa in per-protocol follow-up biopsies?\n\nWhat are the radiological and clinical risk factors for csPCa in per-protocol follow-up biopsies?",[26],[231,497,498,499,500,501,502,503,504,505,506],"magnetic resonance imaging","mri","evolution","progression","pi-rads","significant","likert","pirads","biparametric","bpmri","2026-02-22",{"date":509,"type":38},"2026-02-24",{"date":511,"type":38},"2026-02-23",{"date":513,"type":20},"2037-12-31",{"name":515,"class":45},"University of Eastern Finland",{"id":517,"slug":518,"hasResults":12,"nctId":519,"briefTitle":520,"officialTitle":521,"acronym":4,"eligibilityCriteria":522,"healthyVolunteers":12,"sex":16,"minAge":54,"maxAge":4,"enrollmentInfo":523,"targetDuration":4,"studyType":21,"phases":525,"briefSummary":526,"conditions":527,"keywords":529,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":532,"lastUpdatePostDateStruct":533,"startDateStruct":535,"completionDateStruct":537,"leadSponsor":539,"locationsCount":46},"100601854","psma-pet-for-surveillance-after-focal-therapy-100601854","NCT07115914","PSMA PET for Surveillance After Focal Therapy","Prospective Evaluation of PSMA PET Imaging in Surveillance Post-Focal Therapy for Prostate Cancer (PSMA-FT Surveillance Study)","Inclusion Criteria:\n\n1. Subjects must be male (assigned male at birth) and 18 years or older.\n2. Subjects must demonstrate the ability to understand and provide written informed consent.\n3. Subjects must have histologically confirmed prostate cancer ( PCa) Note: Recruitment will be limited to a maximum of 50% of subjects with favorable intermediate-risk prostate cancer (PCa) Note: The histopathologic diagnosis must be obtained via \"Prostate Biopsy (PB)\", which for the purposes of the present study, is defined as both a systematic 12-core sextant random prostate biopsy and a targeted prostate biopsy. The targeted prostate biopsy can be performed via in-bore multiparemetric (mp) magnetic resonance imaging (MRI) prostate biopsy, cognitive mpMRI\u002Fultrasound fusion prostate biopsy or software mpMRI\u002Fultrasound fusion prostate biopsy. This \"PB\" must not be obtained greater than 1 year from the date of consent.\n4. Subjects must have chosen to get focal therapy (partial gland ablation) for the treatment of prostate cancer and must be scheduled for partial gland ablation\u002Ffocal therapy with any energy modality within 6 months following informed consent.\n5. Subjects must have confirmed non-metastatic PCa following SOC screening for patients with unfavorable intermediate-risk and high risk PCa, a combination of computed tomography imaging of the abdomen and pelvis (CTAP) and technetium-99-mDP nuclear medicine bone scan (BS) and\u002For PSMA-PET imaging prior to enrollment. The imaging studies should be obtained within 6-months of enrollment.\n6. Subjects must be designated as Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 or Karnofsky Performance Status Scale Score ≥ 60%, (see Appendix A).\n7. Subjects must be fit to undergo general anesthesia and the FT surgical procedure, which includes adequate visualization of the prostate gland on transrectal ultrasound imaging, access to the urethra, perineum and rectum, as well as be tolerant of lithotomy positioning in the opinion of the treating investigator or the operating surgeon(s) if not the same as the treating investigator.\n\nExclusion Criteria:\n\n1. Subject had prior or current PCa therapies, such as biologic, chemotherapy, hormone therapy, radiotherapy or surgery for PCa within last 12 months. Subjects who received radiation and\u002For androgen deprivation therapy for prostate cancer more than 12 months prior to diagnosis of recurrent prostate cancer will be eligible for the trial.\n2. Subjects with locally advanced, nodal or metastatic prostate cancer.\n3. Subjects who are unfit for pelvic mpMRI scanning (e.g., severe claustrophobia), permanent cardiac pacemaker, metallic implants that are likely to contribute to significant image artifacts, allergy or contraindication to gadolinium contrast agent.\n4. If the subject has an uncontrolled or major debilitating inter-current illness.\n5. Judgment by the treating investigator or PI that the subject is unsuitable to participate in the study and the subject is unlikely to comply with study procedures, restrictions, and requirements.",{"count":524,"type":20},62,[58],"This study is about adding PSMA PET (Prostate Specific Membrane Antigen- Positron Emission Tomography) to routine magnetic resonance imaging (MRI) scans to help detect prostate cancer recurrence in men who have undergone focal therapy for prostate cancer. PSMA PET and multiparametric (mpMRI are both imaging tests that help detect prostate cancer in the body.\n\nA PSMA PET scan, or prostate-specific membrane antigen positron emission tomography scan, is an imaging test that scans and takes pictures of the prostate. PSMA scans use a specialized radioactive imaging dye that sticks to the proteins that are typically found in prostate cancer cells. This imaging dye helps locate areas of prostate cancer anywhere in the body, both inside and outside prostate.\n\nAn mpMRI, or a multiparametric (mp) MRI scan, is also an imaging test that scans and takes detailed pictures of the prostate. Unlike regular MRIs, an mpMRI produces a more detailed image of the prostate. Similar to PET scans, mpMRI scans also use an imaging dye that helps the pictures of the prostate appear clearer on scans.\n\nThis study will be funded by Blue Earth Diagnostics, a molecular imaging company based in England.",[306,26,528],"Prostate Cancer Metastatic Disease",[530,231,531],"focal therapy","prostate cancer patient","2026-02-13",{"date":534,"type":38},"2026-02-17",{"date":536,"type":38},"2025-11-19",{"date":538,"type":20},"2028-08-01",{"name":540,"class":45},"University of Chicago",{"id":542,"slug":543,"hasResults":12,"nctId":544,"briefTitle":545,"officialTitle":546,"acronym":547,"eligibilityCriteria":548,"healthyVolunteers":12,"sex":16,"minAge":54,"maxAge":4,"enrollmentInfo":549,"targetDuration":4,"studyType":21,"phases":551,"briefSummary":552,"conditions":553,"keywords":554,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":558,"lastUpdatePostDateStruct":559,"startDateStruct":561,"completionDateStruct":563,"leadSponsor":565,"locationsCount":46},"100611688","assessing-a-digital-exercise-intervention-for-health-outcomes-and-engagement-in-regular-exercise-100611688","NCT07243834","Assessing a Digital Exercise Intervention for Health Outcomes and Engagement in Regular Exercise","Assessing a Digital Exercise Intervention for Health Outcomes and Engagement in Regular Exercise (ADHERE): A Randomised Controlled Trial Comparing the Efficacy of a Digital Exercise Intervention With Virtual Supervised Group Exercise Sessions to Standard of Care on Exercise Adherence at Six Months in Patients With Prostate Cancer Undergoing Hormone Therapy.","ADHERE","Inclusion Criteria:\n\n1. Age \\> 18 at randomisation\n2. Men with histological confirmation of prostate adenocarcinoma who are receiving or planned to receive ADT with an LHRHa as part of their PCa treatment\n3. If already started ADT, have received no more than eight weeks ADT at randomisation\n4. Planned for radiotherapy\n5. Assessed by clinical team to be safe to exercise and safe to enter the trial with no absolute contraindications to exercise as defined by clinical guidance\n6. Able to use technological aspects of the intervention including access to MyMarsden and a device for video conferencing\n7. Fluent in English and able to understand instructions\n8. WHO performance status 0-2\n9. Able to give written informed consent\n\nExclusion Criteria:\n\n1. Men planned to receive an androgen receptor-targeted agent (ARTA) or chemotherapy\n2. Absolute contraindication to exercise as defined by ACPICR standards. This includes:\n\n   * New symptoms of angina\n   * New or unstable heart failure\n   * Newly diagnosed diabetes that is not controlled\n   * New or untreated arrhythmias\n   * Resting tachycardia or new bradycardia (not linked to changes in medications)\n   * Symptomatic hypotension\n   * Uncontrolled hypertension (SBP ≥ 180mmHg or DBP≥ 100mmHg)\n3. Unstable spinal bone metastasis or at high risk of a fracture\n4. Musculoskeletal issue inhibiting exercise",{"count":550,"type":20},160,[58],"Patients diagnosed with prostate cancer and receiving hormone therapy in conjunction with radiotherapy are likely to suffer from adverse effects caused by ADT treatment either short term or long term. The most common side effects include changes in body composition leading to increased visceral fat and reduced lean muscle mass, increased risk of cardiovascular events and fatigue, which overall lower quality of life.\n\nThere is strong evidence to support exercise interventions in minimising, and in some cases reversing many ADT -related toxicities, but exercise adherence remains a challenge for people living with prostate cancer, particularly due to logistical barriers to attendance such as cost and travel time, as well as insufficient motivation.\n\nThe aim of this single centre, phase III randomised controlled trial is to assess the efficacy of a new digital exercise programme with virtual supervised group exercise sessions in improving adherence to exercise guidelines.\n\nThe trial aims to recruit 160 participants with prostate cancer undergoing ADT, who will be allocated either the standard of care group or standard of care plus participation in the digital exercise intervention on a 1:1 ratio.\n\nAdherence to physical activity will be measured using a wearable accelerometer, an exercise diary, self-reported questionnaires and clinic based assessments at 3 months, 6 months and 12 months post radiotherapy treatment. Recruitment will take place at the Royal Marsden NHS Foundation Trust, Chelsea.",[114,26],[555,556,557],"Exercise intervention","physical activity","adherence","2026-01-29",{"date":560,"type":38},"2026-01-30",{"date":562,"type":38},"2025-12-16",{"date":564,"type":20},"2030-04-28",{"name":566,"class":45},"Royal Marsden NHS Foundation Trust",{"id":568,"slug":569,"hasResults":12,"nctId":570,"briefTitle":571,"officialTitle":571,"acronym":4,"eligibilityCriteria":572,"healthyVolunteers":12,"sex":16,"minAge":54,"maxAge":4,"enrollmentInfo":573,"targetDuration":4,"studyType":21,"phases":575,"briefSummary":576,"conditions":577,"keywords":578,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":582,"lastUpdatePostDateStruct":583,"startDateStruct":585,"completionDateStruct":587,"leadSponsor":589,"locationsCount":591},"100615952","phase-2-castration-with-abiraterone-250-mg-without-lhrh-analogs-or-blockers-in-patients-with-prostate-cancer-requiring-hormonal-intensification-multicenter-phase-2-100615952","NCT07299292","Castration With Abiraterone 250 mg Without LHRH Analogs or Blockers in Patients With Prostate Cancer Requiring Hormonal Intensification (Multicenter Phase 2)","Inclusion Criteria:\n\n* Age ≥18 years.\n* Histologically confirmed prostate adenocarcinoma.\n* Treated at Hospital Durand (Argentina) or Instituto Oncológico del Oriente Boliviano (Bolivia).\n* Indicated for hormonal intensification (high\u002Fvery high risk candidates for RT, or mHSPC for doublet\u002Ftriplet).\n* No prior ADT.\n* ECOG 0-2; adequate hepatic\u002Frenal function; K+ ≥3.5 mmol\u002FL; controlled BP.\n\nExclusion Criteria:\n\n* Hypersensitivity to ABI\u002Fprednisone; moderate-severe hepatic impairment; uncontrolled hypertension; refractory hypokalemia.\n* Concurrent therapy with strongly contraindicated\u002Finducing drugs affecting ABI levels without possibility of adjustment.",{"count":574,"type":20},60,[23],"Hypothesis\n\nThe use of Abiraterone 250 mg with food + prednisone, without LHRH analogs or blockers (ADT), achieves castration-level testosterone at 30 days in ≥80-90% of cases.",[26],[231,579,580,581],"castration","abiraterone","hormonal intensification","2025-12-09",{"date":584,"type":38},"2025-12-23",{"date":586,"type":38},"2025-12-01",{"date":588,"type":20},"2027-03-30",{"name":590,"class":45},"SMED Clinical Research",3,{"id":593,"slug":594,"hasResults":12,"nctId":595,"briefTitle":596,"officialTitle":596,"acronym":4,"eligibilityCriteria":597,"healthyVolunteers":12,"sex":16,"minAge":133,"maxAge":598,"enrollmentInfo":599,"targetDuration":4,"studyType":21,"phases":600,"briefSummary":601,"conditions":602,"keywords":603,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":610,"lastUpdatePostDateStruct":611,"startDateStruct":613,"completionDateStruct":615,"leadSponsor":617,"locationsCount":46},"100613778","phase-1-robot-assisted-prostate-biopsy-with-a-novel-ultrasound-probe-100613778","NCT07271017","Robot-Assisted Prostate Biopsy With a Novel Ultrasound Probe","Included in the study will be:\n\n* Men between the ages of 40 and 75\n* Men must have one of the following \"high risk\" features:\n\n  1. PSA \\> 4.0 ng\u002Fml and\u002For abnormal digital rectal examination (DRE)\n  2. ASAP (atypical small acinar proliferation) on previous biopsy\n* Men with mpMRI or bpMRI exams, including both PI-RADS ≤2 and PI-RADS ≥3.\n\nExcluded from the study will be patients without available mpMRI exams and patients:\n\n* Females and children because of the prostate cancer targeted disease.\n* Patients who are not recommended or in whom TR or TP prostate biopsy is considered high-risk:\n\n  1. Patients with previous rectal surgery.\n  2. Patients with anal stenosis or coagulopathy.\n  3. Patients on active anticoagulation medication (eg. Coumadin, Lovenox, or Heparin).\n  4. Patients who cannot tolerate periprostatic Lidocaine block anesthesia or in whom anesthesia is considered high-risk.\n* Patients who already had a prostate biopsy taken with the ProBot investigational device.\n* Vulnerable populations, such as prisoners, institutionalized individuals.\n* Patients who are unwilling or unable to sign informed consent (no assent required).","75 Years",{"count":574,"type":20},[370],"Prostate cancer (PCa) is the most diagnosed type of cancer and the second leading cause of cancer related deaths among US men, and its incidence has increased steadily in the last decade. Efforts to address the rise in PCa diagnosis without overdetection and overtreatment include targeted biopsy techniques for clinically significant PCa using magnetic resonance imaging (MRI), and precision targeted biopsy guided by ultrasound and fused to the MRI.\n\nThe study aims to improve prostate biopsy with a novel ultrasound probe and robot developed at Johns Hopkins, the ProBot device. The trial is a Phase 1 clinical trial to evaluate the safety and feasibility of the new device.\n\nProBot is an entirely new concept including a novel ultrasound probe and robot kinematics specifically designed for the prostate. It operates with only two degrees of freedom configured such that the motions for 3D image scanning and biopsy may not deform the prostate gland, thus improving the accuracy of MRI-ultrasound fusion and needle targeting at biopsy.\n\nProBot is a small and lightweight robot (1.3Kg including the ultrasound probe). It allows hands-free operation of its ultrasound probe at 3D image scanning and needle targeting supervised by the urologist.\n\nIn addition to MRI-targeted biopsy (TB), at systematic biopsy (SB), instead of using the common template plan that is the same for all patients, the innovative software optimizes the plan for each patient to obtain a diagnosis that is representative of the whole gland histology. The ProBot robot is also uniquely capable of transrectal (TR) and transperineal (TP) biopsy.\n\nThe aims of the study are to determine the safety and feasibility of the new device at TR and TP biopsies.",[26],[604,605,606,448,607,608,609],"Robot biopsy","Fusion biopsy","MRI targeted biopsy","Personalized biopsy","Precision biopsy","Biopsy optimization","2025-11-25",{"date":612,"type":38},"2025-12-08",{"date":614,"type":38},"2025-09-23",{"date":616,"type":20},"2030-05-31",{"name":618,"class":45},"Johns Hopkins University",{"id":620,"slug":621,"hasResults":12,"nctId":622,"briefTitle":623,"officialTitle":624,"acronym":4,"eligibilityCriteria":625,"healthyVolunteers":12,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":626,"targetDuration":4,"studyType":138,"phases":4,"briefSummary":628,"conditions":629,"keywords":630,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":634,"lastUpdatePostDateStruct":635,"startDateStruct":637,"completionDateStruct":639,"leadSponsor":641,"locationsCount":46},"100613403","virtual-biopsy-of-prostate-cancer-using-psma-pet-and-ai-100613403","NCT07266129","Virtual Biopsy of Prostate Cancer Using PSMA PET and AI","Prostate Cancer Malignancy Grading Using Prostate Specific Membrane Antigen (PSMA) PET and Machine Learning","Inclusion Criteria:\n\n* For patients who have undergone biopsies prior to PET:\n* Patients referred to clinical PET examination\n* For patients who have not had biopsies prior to PET:\n* Patients referred to urologist for suspected prostate cancer based on clinical symptoms or elevated PSA-levels\n\nExclusion Criteria:\n\n* Prostatektomy\n* Body weight under 100 kg\n* MRI incompatible implants or other incompatibilities",{"count":627,"type":20},220,"Prostate cancer is the most common type of cancer in Norwegian men, but many tumors are slow-growing and do not require treatment. Today, MRI is good at detecting suspicious lesions, yet it cannot reliably distinguish aggressive tumors from low-grade ones. As a result, many men undergo repeated invasive biopsies. New PET tracers targeting PSMA improve tumor localization and may correlate with cancer aggressiveness, offering potential for better assessment.\n\nThis project aims to develop a method to predict Gleason Score non-invasively by applying machine learning to PET and MRI data. The work involves early static and dynamic PSMA PET imaging, tracer kinetic modelling, deep learning, and validation of PET-based measurements of PSMA internalization using ex-vivo cellular methods.\n\nIf successful, the project could reduce the number of biopsies, improve diagnostic accuracy, offer full 3D assessment of the prostate, shorten clinical workflows, and help identify patients who would benefit most from PSMA-based radioligand therapy.",[26],[114,631,632,633],"Artificial Intelligence","Positron Emission Tomography","Prostate Specific Membrane Antigen","2025-11-24",{"date":636,"type":38},"2025-12-05",{"date":638,"type":38},"2024-06-03",{"date":640,"type":20},"2027-12",{"name":642,"class":45},"University Hospital of North Norway",{"id":644,"slug":645,"hasResults":12,"nctId":646,"briefTitle":647,"officialTitle":648,"acronym":4,"eligibilityCriteria":649,"healthyVolunteers":12,"sex":16,"minAge":54,"maxAge":4,"enrollmentInfo":650,"targetDuration":4,"studyType":138,"phases":4,"briefSummary":652,"conditions":653,"keywords":656,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":660,"lastUpdatePostDateStruct":661,"startDateStruct":663,"completionDateStruct":665,"leadSponsor":667,"locationsCount":591},"100603087","immune-biomarkers-in-prostate-cancer-patients-treated-with-brachytherapy-100603087","NCT07131956","Immune Biomarkers in Prostate Cancer Patients Treated With Brachytherapy","Immune Biomarkers in Prostate Cancer Patients Treated With Brachytherapy (ImmunBioProBrachy)","Inclusion Criteria Arm 1:\n\n* Primary treatment with I-125 seeds or HDR-BT\n* No previous treatment for prostate cancer\n* Age ≥ 18 years\n\nInclusion Criteria Arm 2:\n\n* HDR- or PDR-BT\n* No radiation therapy within three months before salvage treatment\n* Complete documentation available on previous treatment for prostate cancer\n* No history of prostatectomy\n* Age ≥ 18 years\n\nExclusion Criteria:\n\n* Pre-existent auto-immune disease\n* patients under bloodthinning medication\n* substance abuse",{"count":651,"type":20},200,"Analysis of peripheral immune cells before, during, and after brachytherapy treatment. Corresponding analysis of tissue samples collected during brachytherapy treatment.",[26,654,304,655],"Prostate Cancer Patients Who Have Brachytherapy Seed Implant","Prostate Cancer Recurrent",[657,658,659],"Immune-profiling in prostate cancer patients","brachytherapy for prostate cancer","interstitial brachytherapy for prostate cancer","2025-11-17",{"date":662,"type":38},"2025-11-18",{"date":664,"type":20},"2025-12",{"date":666,"type":20},"2028-07-31",{"name":668,"class":45},"University of Erlangen-Nürnberg Medical School",{"id":670,"slug":671,"hasResults":12,"nctId":672,"briefTitle":673,"officialTitle":673,"acronym":4,"eligibilityCriteria":674,"healthyVolunteers":107,"sex":16,"minAge":54,"maxAge":466,"enrollmentInfo":675,"targetDuration":4,"studyType":138,"phases":4,"briefSummary":677,"conditions":678,"keywords":681,"overallStatus":90,"whyStopped":4,"lastUpdateSubmitDate":683,"lastUpdatePostDateStruct":684,"startDateStruct":686,"completionDateStruct":687,"leadSponsor":688,"locationsCount":690},"100611313","application-of-quantum-detection-driven-artificial-intelligence-algorithms-for-single-molecule-cfdna-characterization-in-the-early-diagnosis-of-prostate-cancer-100611313","NCT07238959","Application of Quantum Detection-Driven Artificial Intelligence Algorithms for Single-Molecule cfDNA Characterization in the Early Diagnosis of Prostate Cancer","Inclusion Criteria:\n\n1. Male, aged 18-80 years;\n2. PSA \\> 4 ng\u002Fml;\n3. Patients meeting criteria for prostate biopsy:\n\n   * fPSA\u002FPSA \\\u003C 0.16 or PSA D \\> 0.15 or PSA V \\> 0.75; ② Positive digital rectal examination (DRE); ③ Imaging studies (ultrasound\u002FMRI) showing suspicious lesions.\n\nExclusion Criteria:\n\n1. Patients diagnosed with any malignant tumour within the past five years;\n2. Patients who have undergone transurethral resection or enucleation of the prostate;\n3. Patients who have previously received treatment for prostate cancer, including but not limited to endocrine therapy, targeted therapy, or immunotherapy;\n4. Patients on long-term anticoagulant or antiplatelet therapy (anticoagulants discontinued for less than one week);\n5. Patients who have received any form of tumour treatment prior to enrolment blood sampling, including surgery, radiotherapy\u002Fchemotherapy, endocrine therapy, targeted therapy, or immunotherapy;\n6. Concurrent severe systemic diseases deemed by the investigator likely to interfere with trial treatment, evaluation, or compliance, including serious respiratory, circulatory, neurological, psychiatric, gastrointestinal, endocrine, immunological, or urological disorders;\n7. Organ transplant recipients or individuals with prior non-autologous (allogeneic) bone marrow or stem cell transplantation;\n8. Subjects who have undergone blood transfusion within one month prior to blood sampling;\n9. Patients currently participating in other clinical trials, or who have participated in other clinical trials within the past year;\n10. Patients deemed unsuitable for this clinical trial by the investigator;\n11. Patients meeting any of the above criteria shall not be eligible for inclusion as subjects.",{"count":676,"type":20},1100,"This research project aims to develop a novel blood testing method integrating cutting-edge quantum sensing and artificial intelligence technologies to achieve precise, non-invasive early diagnosis of prostate cancer. The research will employ quantum sensors to perform ultra-high-sensitivity measurements of circulating free DNA (cfDNA) in blood, thereby training a dedicated AI diagnostic model. The ultimate objective is to establish the diagnostic efficacy of this approach through clinical validation, providing clinicians with a novel diagnostic tool capable of significantly reducing unnecessary prostate biopsy procedures.",[679,26,680],"Benign Prostate Hypertrophy(BPH)","Prostate Neoplasm",[115,682],"cfDNA","2025-11-15",{"date":685,"type":38},"2025-11-20",{"date":664,"type":20},{"date":640,"type":20},{"name":689,"class":45},"Shanghai Changzheng Hospital",7]