[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"prostate-biopsy\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:prostate-biopsy":25},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,8,0,[8,41,75,101,133,175,199,225],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":17,"targetDuration":4,"studyType":20,"phases":21,"briefSummary":23,"conditions":24,"keywords":26,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":4},"100637680","a-multicenter-randomized-controlled-superiority-trial-comparing-robotic-assisted-versus-expert-cognitive-fusion-prostate-biopsy-in-obese-men-100637680",false,"NCT07600216","A Multicenter, Randomized Controlled Superiority Trial Comparing Robotic-Assisted Versus Expert Cognitive Fusion Prostate Biopsy in Obese Men","Inclusion Criteria:\n\n* Age ≥ 40 years.\n* Serum PSA levels between 4 and 20 ng\u002Fml and\u002For abnormal digital rectal examination (DRE).\n* High Body Mass Index (BMI): defined as ≥ 28 kg\u002Fm ² for Asian cohorts and ≥ 30 kg\u002Fm ² for Non-Asian cohorts.\n* MRI-Positive: Presence of at least one suspicious lesion (PI-RADS score ≥ 3) on mpMRI.\n* Fitness for transperineal biopsy under local anaesthesia or conscious sedation.\n\nExclusion Criteria:\n\n* Prior treatment for prostate cancer.\n* History of major anorectal surgery preventing safe transperineal probe insertion.\n* Contraindications to MRI.\n* Negative screening MRI (PI-RADS 1-2).","MALE","40 Years",{"count":18,"type":19},570,"ESTIMATED","INTERVENTIONAL",[22],"NA","The trial aims to find out if using a robotic system to help perform prostate biopsies is better than having a highly experienced doctor perform the biopsy by hand in men with a high Body Mass Index (BMI).\n\nWhile MRI-guided prostate biopsies are highly effective, carrying them out in men with obesity can be physically challenging for doctors. Extra pelvic tissue increases the depth the biopsy needle must travel and makes it difficult to manually hold the ultrasound probe perfectly steady. This physical difficulty might cause doctors to miss some aggressive prostate cancers.\n\nThis study tests whether a robotic arm-which completely locks the biopsy needle on target and eliminates human hand tremors-can improve cancer detection. The study will enroll up to 570 men with high BMI who have suspicious areas on their prostate MRI. Participants will be randomly assigned to receive either a robotic-assisted biopsy or a standard manual biopsy performed by an expert urologist.\n\nTo ensure the results are completely unbiased, participants will not know which method is being used on them. They will be placed behind a surgical drape and wear noise-canceling headphones playing music during the procedure to block out the sounds of the robotic motors. The main goal is to see if the robotic method safely and significantly increases the detection rate of clinically significant prostate cancer in this specific group of patients.",[25],"Prostate Biopsy",[27,28],"prostate biopsy","targeted biopsy","NOT_YET_RECRUITING","2026-06-21",{"date":32,"type":33},"2026-06-24","ACTUAL",{"date":35,"type":19},"2026-05-30",{"date":37,"type":19},"2028-05-30",{"name":39,"class":40},"Shanghai East Hospital","OTHER",{"id":42,"slug":43,"hasResults":11,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":47,"eligibilityCriteria":48,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":49,"targetDuration":4,"studyType":20,"phases":51,"briefSummary":52,"conditions":53,"keywords":56,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":65,"lastUpdatePostDateStruct":66,"startDateStruct":68,"completionDateStruct":70,"leadSponsor":72,"locationsCount":74},"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":50,"type":19},140,[22],"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.",[54,25,55],"Prostate Cancer (Diagnosis)","Pain, Procedural",[57,58,59,60,61,62,63,64],"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":67,"type":33},"2026-05-11",{"date":69,"type":19},"2026-06",{"date":71,"type":19},"2027-02",{"name":73,"class":40},"Medical University of Gdansk",1,{"id":76,"slug":77,"hasResults":11,"nctId":78,"briefTitle":79,"officialTitle":80,"acronym":81,"eligibilityCriteria":82,"healthyVolunteers":11,"sex":15,"minAge":83,"maxAge":4,"enrollmentInfo":84,"targetDuration":4,"studyType":20,"phases":86,"briefSummary":87,"conditions":88,"keywords":4,"overallStatus":91,"whyStopped":4,"lastUpdateSubmitDate":92,"lastUpdatePostDateStruct":93,"startDateStruct":95,"completionDateStruct":97,"leadSponsor":99,"locationsCount":74},"100635307","routine-probe-compression-after-transrectal-prostate-biopsyrpcab-to-reduce-bleeding-and-infectious-complications--a-randomized-controlled-trial-100635307","NCT07550985","Routine Probe Compression After Transrectal Prostate Biopsy(RPCAB) to Reduce Bleeding and Infectious Complications : A Randomized Controlled Trial","A Randomized Controlled Trial Evaluating the Effect of Routine Probe Compression After Transrectal Prostate Biopsy on Bleeding and Infectious Complications","RPCAB","Inclusion Criteria:\n\n* Male patients aged ≥18 years Scheduled to undergo transrectal ultrasound-guided prostate biopsy Biopsy-naïve patients (first-time prostate biopsy) Able to provide written informed consent\n\nExclusion Criteria:\n\n* Uncorrectable coagulopathy or bleeding disorder Active urinary tract infection at the time of biopsy Acute anorectal conditions (e.g., hemorrhoidal bleeding, anal fissure, proctitis) Inability to discontinue or appropriately manage anticoagulant or antiplatelet therapy History of severe drug allergy or hypersensitivity to medications used in the study Individuals unable to provide informed consent (e.g., cognitive impairment, medically incapacitated) or other vulnerable populations Participation in another interventional study related to prostate disease that may interfere with the outcomes of this study Severe comorbid conditions limiting study participation Inability to comply with follow-up procedures","18 Years",{"count":85,"type":19},324,[22],"Hematuria (up to 50%) and rectal bleeding (up to 30%) are common complications following transrectal ultrasound-guided prostate biopsy. Although most cases are mild, some require additional intervention. Short-duration compression has been shown to achieve hemostasis in cases of post-biopsy bleeding, suggesting that routine probe compression may reduce bleeding complications. Post-biopsy bleeding may also be associated with an increased risk of subsequent infection.\n\nThis randomized controlled trial aims to evaluate the effect of routine probe compression and compression duration after transrectal prostate biopsy on bleeding and infectious complications.",[25,89,90],"Post Biopsy Bleeding","Transrectal Ultrasound-guided Prostate Biopsy","RECRUITING","2026-04-19",{"date":94,"type":33},"2026-04-24",{"date":96,"type":33},"2026-03-30",{"date":98,"type":19},"2027-02-28",{"name":100,"class":40},"Veterans Health Service Medical Center, Seoul, Korea",{"id":102,"slug":103,"hasResults":11,"nctId":104,"briefTitle":105,"officialTitle":106,"acronym":4,"eligibilityCriteria":107,"healthyVolunteers":11,"sex":108,"minAge":83,"maxAge":109,"enrollmentInfo":110,"targetDuration":4,"studyType":20,"phases":112,"briefSummary":113,"conditions":114,"keywords":121,"overallStatus":91,"whyStopped":4,"lastUpdateSubmitDate":124,"lastUpdatePostDateStruct":125,"startDateStruct":127,"completionDateStruct":129,"leadSponsor":131,"locationsCount":74},"100618951","virtual-reality-induced-pain-and-anxiety-relief-in-outpatient-urological-procedures-100618951","NCT07338292","VIrtual Reality Induced Pain and anxiEty Relief in Outpatient UROlogical Procedures","VIrtual Reality Induced Pain and anxiEty Relief in Outpatient UROlogical Procedures: a Post-marketing Clinical Investigation of REALICA","Inclusion Criteria:\n\n* Male\u002Ffemale with age ≥ 18 years\n* Patient who are undergoing one of the interventions mentioned in the study for the first time;\n* Eligibility for minimally invasive ambulatory urological procedures, possibly requiring vascular access (circumcision, prostate biopsy, flexible cystoscopy);\n* Ability to understand instructions and complete study questionnaires;\n* Signed informed consent.\n\nExclusion Criteria:\n\n* Absolute contraindications to the planned urological procedure (e.g., active urinary tract infection, anatomical urethral abnormalities);\n* Recent urological manipulations (e.g., urethral dilation, bladder biopsy, insertion or removal of a double-J stent);\n* Medical contraindications to the use of virtual reality, including uncontrolled photosensitive epilepsy and relevant neurological, ophthalmologic, or otolaryngologic disorders;\n* Presence of severe psychiatric disorders or major cardiovascular diseases that may interfere with study participation;\n* Previous adverse reactions to virtual reality exposure;\n* Use of analgesic medications within 24 hours prior to the procedure;\n* Use of drugs that may alter consciousness or impair the ability to complete psychological assessments;\n* Severe communication disabilities or significant hearing impairment that would prevent completion of questionnaires.","ALL","99 Years",{"count":111,"type":19},56,[22],"Though the efficacy of VRH is documented in various outpatient urological procedures and has provided promising preliminary information in prostate biopsy, its systematic use in urology remains poorly studied. Considering the potential of invasive urological procedures to induce significant patient discomfort, the application of innovative immersive approaches, such as those offered by medical devices, could lead to an overall clinical benefit. Among these, REALICA® (available from https:\u002F\u002FREALICA.io\u002Fen\u002F), a class I CE medical device, widely used in hospitals and validated by numerous studies, represents a valuable resource in urology, supported by high satisfaction rates received in abdominal surgery and extracorporeal lithotripsy",[115,25,116,117,118,119,120],"Urologic Diseases","Flexible Cystoscopy","Circumcision","Stress","Anxiety","Pain",[122,123],"virtual reality","medical device","2026-01-07",{"date":126,"type":33},"2026-01-13",{"date":128,"type":33},"2025-12-17",{"date":130,"type":19},"2026-10-31",{"name":132,"class":40},"Istituto Oncologico Veneto IRCCS",{"id":134,"slug":135,"hasResults":11,"nctId":136,"briefTitle":137,"officialTitle":138,"acronym":139,"eligibilityCriteria":140,"healthyVolunteers":141,"sex":15,"minAge":83,"maxAge":4,"enrollmentInfo":142,"targetDuration":4,"studyType":20,"phases":144,"briefSummary":146,"conditions":147,"keywords":156,"overallStatus":91,"whyStopped":4,"lastUpdateSubmitDate":165,"lastUpdatePostDateStruct":166,"startDateStruct":168,"completionDateStruct":170,"leadSponsor":172,"locationsCount":74},"100596956","phase-3-psma-pet-combined-with-mri-for-the-detection-of-pca-100596956","NCT07052214","PSMA PET Combined With MRI for the Detection of PCa","A Single Arm, Multicenter, Prospective, Open Label, Longitudinal Phase 3 Study of Prostate Specific Membrane Antigen (PSMA) Positron Emission Tomography (PET) Combined With Magnetic Resonance Imaging (MRI) Compared to Standard of Care (SOC) for the Detection of Prostate Cancer (PCa).","BiPASS","Inclusion Criteria:\n\n1. Male, at least 18 years old.\n2. Have a clinical suspicion of PCa, and will undergo template biopsy, based on either: an initial MRI examination (PI-RADS 3-4) within 3 months (92 days) before enrollment, or no MRI evidence (PI-RADs 1-2) within 3 months (92 days) before enrollment, but a clinician indicated intent to proceed with template biopsy due to non-imaging risk factors.\n\nThese are non-imaging risk factors that would lead a patient to be considered for a template biopsy (including but not exclusive to):\n\n1. Persistently elevated or rising PSA i. PSA ≥ 3.0 ng\u002FmL ii. Rising PSA velocity (e.g., \\>0.35-0.75 ng\u002FmL\u002Fyear over 2-3 years) is also considered suspicious, especially in men with PSA\\\u003C10ng\u002FmL.\n2. High PSA density (PSAD) i. PSA density \\> 0.15 ng\u002FmL\u002Fcm³ is considered high-risk for csPCa. ii. Calculated as PSA (ng\u002FmL) divided by prostate volume (from MRI).\n3. Abnormal digital rectal examination (DRE) i. abnormal findings include:\n\n   1. Nodules\n   2. Induration\n   3. Asymmetry\n   4. Fixation of the prostate ii. An abnormal DRE in any PSA range (including \\\u003C3 ng\u002FmL) increases cancer suspicion.\n\nb) Strong family history of prostate cancer: i. First-degree relative (father or brother) with PCa ii. Any relative diagnosed at \\\u003C65 years of age iii. Multiple affected relatives iv. Known hereditary cancer syndromes (e.g., BReast CAncer gene \\[BRCA\\]1\u002F2, Homeobox protein Hox-B13 \\[HOXB13\\] mutations) c) Other high-risk biomarkers i. 4Kscore: ≥ 7.5-10% risk of high-grade PCa ii. PHI (Prostate Health Index): ≥ 35 suggests elevated risk iii. Prostate Cancer Antigen 3 (PCA3) Score: ≥ 35 considered positive and associated with increased risk of PCa.\n\niv. Any other established biomarker with values in the high-risk range d) Clinical presentation i. Symptoms suggestive of locally advanced disease (e.g., urinary obstruction, bone pain) ii. Prior negative MRI with ongoing clinical concern 3. Prostate biopsy naïve participants. 4. Eastern Cooperative Oncology Group performance status (ECOG PS) ≤2 per FDA guidelines. 5. Have the capacity to understand the study and be able and willing to comply with all protocol requirements. 6. Provides consent for anatomical template with\u002Fwithout targeted biopsy based on clinical risk, MRI and PSMA PET result. 7. Participants must comply with the radiation protection rules (including hospital admissions and isolation) that are used by the treating institution to protect their contacts and the general public, especially if a female partner of the participant is or could be pregnant.\n\n8\\. Must agree to practice adequate precautions to prevent pregnancy in a female partner and to avoid potential problems associated with radiation exposure to the unborn child (Recommendations related to contraception and pregnancy testing in clinical trials Version 1.1, (CTFG \\[Clinical Trial Facilitation Group\\], 2020). Details of contraceptive measures to be taken by male participants and their female partners are described in Appendix 4 of the Protocol.\n\nExclusion Criteria:\n\nParticipants are excluded from the study if any of the following criteria apply:\n\n1. Has had prior treatment for PCa or prior diagnosis of csPCa.\n2. Obvious metastatic disease on prior conventional imaging.\n3. Previous diagnosis of cancer of any primary origin (excluding basal cell carcinoma or squamous cell carcinoma of the skin that has undergone potentially curative therapy).\n4. Active prostate infection, or urinary test results suggestive of an active urinary tract infection, evident on medical history, within 4 weeks of enrollment.\n5. Prior pelvic irradiation\n6. Demonstrate radiographic findings of PI-RADS 5.\n7. Has abnormalities in physical examination and protocol-specified clinical laboratory tests during the Screening Period that, in the judgment of the investigator, could affect safety or compliance; and\u002For is deemed not suitable for participating in this trial in the opinion of the investigator.\n8. Unable to understand or is unwilling to sign a written informed consent document or to follow investigational procedures in the opinion of the investigator.\n9. Is unable to attain or remain in a supine position while a PET\u002FCT scan is being performed or unable to tolerate a PET\u002FCT scan\n10. Unable or unwilling to undergo clinical prostate biopsy, has known allergies, hypersensitivity, or intolerance to the investigational drug\u002Fcomparator or its excipients.\n11. Have prior use of radionuclides with an interval of less than 10 effective half-lives before the administration of 68Ga-PSMA-11.\n12. Is participating or plans to participate in any experimental drug or device trial during the study period that are considered outside of therapeutic SOC. Studies involving modifications of sequencing or timing of therapeutic regimens\u002Finterventions would be deemed eligible to enroll",true,{"count":143,"type":19},204,[145],"PHASE3","This is an open label, longitudinal Phase 3 study of prostate specific membrane antigen (PSMA) positron emission tomography (PET) combined with magnetic resonance imaging (MRI) compared to standard of care (SOC) for the detection of prostate cancer (PCa).",[148,149,150,151,152,153,154,25,155],"PCA","Prostate Cancer","Prostatic Neoplasm","PSMA PET","Diagnostic Imaging","Elevated PSA","Positron Emission Tomography","Carcinoma of the Prostate",[157,158,159,160,161,162,163,164],"Molecular Imaging","Biopsy Naive","Magnetic Resonance Imaging","Biopsy","Targeted Biopsy","Radiopharmaceuticals","Cancer Detection","Urologic Oncology","2025-09-03",{"date":167,"type":33},"2025-09-10",{"date":169,"type":33},"2025-08-18",{"date":171,"type":19},"2026-11",{"name":173,"class":174},"Telix Pharmaceuticals (Innovations) Pty Limited","INDUSTRY",{"id":176,"slug":177,"hasResults":11,"nctId":178,"briefTitle":179,"officialTitle":179,"acronym":180,"eligibilityCriteria":181,"healthyVolunteers":141,"sex":15,"minAge":16,"maxAge":182,"enrollmentInfo":183,"targetDuration":4,"studyType":185,"phases":4,"briefSummary":186,"conditions":187,"keywords":4,"overallStatus":91,"whyStopped":4,"lastUpdateSubmitDate":190,"lastUpdatePostDateStruct":191,"startDateStruct":193,"completionDateStruct":195,"leadSponsor":197,"locationsCount":74},"100250829","the-profile-study-germline-genetic-profiling-correlation-with-targeted-prostate-cancer-screening-and-treatment-100250829","NCT02543905","The PROFILE Study: Germline Genetic Profiling: Correlation With Targeted Prostate Cancer Screening and Treatment","PROFILE","Inclusion Criteria:\n\nEither:\n\n1. Men of any ethnicity with a positive family history of PrCa defined as:\n\n   * Men with a first degree relative (or second degree if through female line) with histologically or death certificate proven PrCa diagnosed at \\\u003C70 years\n   * Men with two relatives on the same side of the family with histologically or death certificate proven PrCa where at least one is diagnosed at \\\u003C70 years\n   * Men with three relatives on the same side of the family with histologically or death certificate proven PrCa diagnosed at any age\n\n   Or\n2. Men of black African or black African-Caribbean ancestry defined as:\n\n   Both parents and all 4 grandparents being of either black African or black African-Caribbean ancestry.\n\n   Or\n3. Men of any ethnicity with a genetic predisposition to having prostate cancer e.g., being known to have inherited a gene mutation that increases risk of prostate cancer (e.g. BRCA1, BRCA2, ATM, PALB2, MLH1, MSH2, MSH6, CHEK2 and other DNA repair gene mutations as listed in the study protocol); and\u002For being known to have a high polygenic risk score (PRS) (defined as being in the top tenth percentile prior to enrolment).\n\n   * Age 40- 69 years\n   * WHO performance status 0-2\n   * Absence of any psychological, familial, sociological or geographical situation potentially hampering compliance with the study protocol and follow up schedule.\n\nExclusion Criteria:\n\n* Previous cancer with a life expectancy of less than five years.\n* Previous PrCa\n* Negative biopsy within one year before recruitment\n* Co-morbidities making prostate biopsy risk unacceptable (anticoagulants or antiplatelet medication including Warfarin, Clopidogrel, Apixaban, Dabigatran or other NOAC (Novel Oral Anti-Coagulant); poorly controlled diabetes, cardiovascular\u002Frespiratory disease, immunosuppressive medication or splenectomy)\n* Men with body mass index (BMI) 40 and above.\n* Men with BMI 35 and above plus other co-morbidities.\n* Contraindications to having an MRI (non-MRI compliant pacemakers, aneurysm clips, metallic cardiac valve\u002Fstent, Ventriculo-Peritoneal (VP) shunt, cochlear implant, neurotransmitter, metallic foreign bodies in eye(s), other metalwork, claustrophobia)\n* Any significant psychological conditions that may be worsened or exacerbated by participation in the study","69 Years",{"count":184,"type":19},1600,"OBSERVATIONAL","Prostate cancer is now the most common cancer in men in the Western world. In the United Kingdom (UK), there were over 52,000 new cases diagnosed in 2016-2018 and a lifetime risk of 1 in 8. Prostate cancer (PrCa) can run in some families and research studies have identified several genetic changes in Caucasian populations that are thought to increase the risk of developing prostate cancer. Other studies have shown that men from certain ethnic groups also have a higher risk of prostate cancer, and this includes men of black African or black African-Caribbean ancestry. This study aims to look at men with a higher risk of prostate cancer based on their ethnicity, family history and\u002For genetic predisposition to see whether any of these genetic changes are present in their DNA (genetic material) and whether this could be a helpful screening tool in prostate cancer screening programmes. It is thought that many genetic changes are involved in the development of prostate cancer and research is being carried out worldwide to identify these genetic changes. Some of these changes may cause a very slight increase in prostate cancer risk while others may cause a much larger increase in risk of developing prostate cancer. The investigators will invite (i) men of any ethnicity with a family history of prostate cancer; (ii) men of black African or black African-Caribbean ancestry; and (iii) men of any ethnicity with a known genetic predisposition to having prostate cancer (e.g., being known to have inherited a gene mutation that increases risk of prostate and\u002For being known to be in the top tenth percentile of the polygenic risk score (high PRS score prior to enrolment) for targeted prostate screening (Prostate Specific Antigen (PSA) testing, MRI and a biopsy of the prostate gland) and genetic profiling. The outcome of these prostate cancer screening investigations will be compared with the genetic profiles of those taking part in the study in order to look for certain genetic changes in the gene code that are thought to increase prostate cancer risk. This research will help us to determine what the role of such genetic profiling is in a prostate cancer screening programme and if it helps identify men at high prostate cancer risk.",[149,25,188,189],"Genetic Counselling","Genetic Markers","2025-07-24",{"date":192,"type":33},"2025-07-25",{"date":194,"type":33},"2015-03-09",{"date":196,"type":19},"2026-12-31",{"name":198,"class":40},"Institute of Cancer Research, United Kingdom",{"id":200,"slug":201,"hasResults":11,"nctId":202,"briefTitle":203,"officialTitle":204,"acronym":205,"eligibilityCriteria":206,"healthyVolunteers":11,"sex":15,"minAge":83,"maxAge":4,"enrollmentInfo":207,"targetDuration":4,"studyType":20,"phases":209,"briefSummary":210,"conditions":211,"keywords":212,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":216,"lastUpdatePostDateStruct":217,"startDateStruct":219,"completionDateStruct":221,"leadSponsor":223,"locationsCount":74},"100569222","evaluation-of-the-effect-on-pain-of-attentional-diversion-associated-with-hypnotic-induction-by-virtual-reality-vrh-in-perioperative-prostate-biopsies-under-local-anesthesia-100569222","NCT06691438","Evaluation of the Effect on Pain of Attentional Diversion Associated with Hypnotic Induction by Virtual Reality (VRH) in Perioperative Prostate Biopsies Under Local Anesthesia:","Evaluation of the Effect on Pain of Attentional Diversion Associated with Hypnotic Induction by Virtual Reality (VRH) in Perioperative Prostate Biopsies Under Local Anesthesia: Prospective Randomized and Controlled Trial","HYPNOSURG-VR","Inclusion Criteria:\n\n* Adult patients who are candidates for ultrasound-guided prostate biopsies under local anesthesia, via transperineal or transrectal route\n* Patient having signed informed consent\n\nExclusion Criteria:\n\n* Patient suffering from blindness or any other visual handicap that contraindicates the use of the headset\n* Deaf or hard of hearing patients\n* Patients suffering from epilepsy and\u002For mental deficiency, and\u002For disorders of higher functions\n* Psychotic patients\n* Claustrophobic patients or those who cannot tolerate a mask over their eyes\n* Refusal of local anesthesia\n* Protected person (art. L1121-5 to L1121-8 of the CSP)",{"count":208,"type":19},130,[22],"The primary objective of the study is to prospectively compare perioperative pain assessed in patients undergoing targeted prostate biopsies, either transrectally or transperineally, under local anesthesia with or without a virtual reality hypnosis headset. The study was sized based on a mean pain reduction of 1.5 points on a numerical scale (0-10 NAS), with an estimate of procedure-related pain of 4.0 on the NAS scale.",[25],[213,120,214,215],"Sedation","Hypnosis","Virtual Reality","2024-11-14",{"date":218,"type":33},"2024-11-15",{"date":220,"type":19},"2024-12-01",{"date":222,"type":19},"2026-10-01",{"name":224,"class":40},"University Hospital, Grenoble",{"id":226,"slug":227,"hasResults":11,"nctId":228,"briefTitle":229,"officialTitle":230,"acronym":231,"eligibilityCriteria":232,"healthyVolunteers":141,"sex":15,"minAge":233,"maxAge":234,"enrollmentInfo":235,"targetDuration":4,"studyType":20,"phases":237,"briefSummary":238,"conditions":239,"keywords":4,"overallStatus":91,"whyStopped":4,"lastUpdateSubmitDate":247,"lastUpdatePostDateStruct":248,"startDateStruct":250,"completionDateStruct":252,"leadSponsor":254,"locationsCount":74},"100492932","tranberg-transperineal-mrus-fusion-laser--induced-thermal-therapy-for-men-with-prostate-cancer-100492932","NCT05698576","TRANBERG® Transperineal MR\u002FUS Fusion Laser--Induced Thermal Therapy for Men With Prostate Cancer","TRANBERG® Transperineal MR\u002FUS Focalyx Fusion Laser--Induced Thermal Therapy in the Office Setting Under Local Anesthesia","TPF-LITT","Inclusion Criteria:\n\n* Willing and able to sign informed consent\n* Subject is able and willing to complete all procedure and follow-up visits indicated in the protocol\n* Absence of urinary retention\n* Prostate volume: ≥ 18 and ≤ 100 cc, measured by transrectal ultrasound\n* Serum creatinine levels \\\u003C2 ng\u002Fdl and GFR \\> 45\n* Serum PSA levels \\\u003C 20 ng\u002Fml\n* Multiparametric prostate MRI with piRADS scores 3-5\n* Prostate volume: ≥ 18 and ≤ 100 cc, measured by MRI\n* Presence of Intermediate risk prostate cancer with a volume that is less than 1\u002F3 of the gland volume by MRI evaluation\n\nExclusion Criteria:\n\n* Post-void residual (PVR): \\> 250 mL or \\> 50% of voided volume\n* Previous prostate cancer intervention (Radiation therapy, brachytherapy, prostate cryoablation\n* Major neurological conditions such as Alzheimer's, Parkinson, Multiple sclerosis, ALS, spinal cord injury\n* Evidence of neurogenic bladder determined by urodynamics studies\n* Presence of Indwelling Foley catheter or on active regime of clean intermittent catheterization (CIC) in the prior 30 days\n* Active urinary tract infection determined by urinary cultures\n* SHIM score \\\u003C14\n* IPSS score \\>23\n* Acute prostatitis\n* Macroscopic hematuria without a known contributing factor\n* History of colorectal carcinoma with anterior perineal resection of rectum\n* History of pelvic radiation therapy or radical pelvic surgery\n* History of bladder neck contracture and\u002For urethral strictures within the 5 years prior to the informed consent date\n* Bladder stones\n* Medical contraindication for undergoing TPFLA surgery (eg, infection, coagulopathy, significant cardiac or other medical risk factors for surgery)\n* Diagnosed or suspected bleeding or coagulopathic disorder such as hemophilia, ITP, TTP\n* Medical contraindication to being subjected to local anesthesia","50 Years","80 Years",{"count":236,"type":19},20,[22],"This study is set up as a phase I prospective, single center, device interventional pilot study carried in office setting under local anesthesia. It will assess the tolerance and safety of target fusion ablation of prostate cancer tumors using Laser Induced Thermal Therapy (TFA-LITT) guided by fusion imaging in men 50 to 80 years of age with low to intermediate risk prostate cancer\n\nProstate Cancer is currently managed with in a discrete fashion where patients either enroll in active surveillance protocols (No intervention) or undergo full intervention via whole gland treatments - most commonly radical surgery or radiation. These treatments have not shown definitive gains in all cause survival and not uncommonly harbor undesirable adverse effects, most notably: impotency and incontinence. Such events elicit significant and noticeable changes on a male lifestyle and for most prostate cancer tumors are considered overtreatment. This study aims to evaluate the use of TFA-LITT in the office setting under local anesthesia - greatly decreasing patient perioperative surgical risk - focused on the organ sparing cancer lesion ablation, where organ function is preserved.\n\nThe fundamental objective is to determine the tolerance and safety of TFA-LITT in men with low to intermediate risk prostate cancer, successful performed in the outpatient office-based setting under local anesthesia directed by fusion imaging. Secondary objectives include: 1-Biopsy proven cancer control of ablated areas 12 months after procedure; 2-Uroflowmetry and urinary function Patient Reported Outcome Measures (PROMs) at one, three, six, nine and 12 months; 3- Sexual function Patient Reported Outcome Measures (PROMs) at one, three, six, nine and 12 months; 4- MRI changes of ablated area one, three and 12 months after TFA-LITT; 5- Absence or presence of ejaculation after TFA-LITT.",[149,240,241,242,243,244,245,25,246],"Adverse Effects Surgery","MRI","Ultrasound","Sexual Function Disturbances","Urinary Incontinence","Urinary Function Disorders","Ablation","2023-01-24",{"date":249,"type":33},"2023-01-26",{"date":251,"type":33},"2022-03-16",{"date":253,"type":19},"2033-01-30",{"name":255,"class":40},"Urological Research Network, LLC"]