[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100636058":3},{"organization":4,"outcomesModule":7,"designInfo":77,"detailedDescription":76,"studyPopulation":80,"armGroups":76,"interventions":76,"overallOfficials":76,"centralContacts":76,"locations":76,"responsibleParty":81,"collaborators":76,"id":83,"slug":76,"hasResults":84,"nctId":85,"briefTitle":86,"officialTitle":86,"acronym":87,"eligibilityCriteria":88,"healthyVolunteers":84,"sex":89,"minAge":90,"maxAge":76,"enrollmentInfo":91,"targetDuration":94,"studyType":95,"phases":76,"briefSummary":96,"conditions":97,"keywords":76,"overallStatus":100,"whyStopped":76,"lastUpdateSubmitDate":101,"lastUpdatePostDateStruct":102,"startDateStruct":105,"completionDateStruct":107,"leadSponsor":109,"locationsCount":76},{"fullName":5,"class":6},"Radboud University Medical Center","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":50,"otherOutcomes":76},[9,13,17,21,25,29,32,35,38,41,44,47],{"measure":10,"description":11,"timeFrame":12},"Treatment patterns","Documentation of initial and sequential treatment strategies, including type, timing, and combination of androgen deprivation therapy, androgen receptor pathway inhibitors, chemotherapy, and radiotherapy, within 4 months and beyond 4 months after diagnosis.","From diagnosis through study completion, up to 4 years",{"measure":14,"description":15,"timeFrame":16},"PSA response","Proportion of patients achieving \\>50% and \\>90% PSA decline from baseline within the first year after treatment initiation.","From treatment initiation up to 12 months.",{"measure":18,"description":19,"timeFrame":20},"PSA nadir","Lowest PSA value achieved within 1 year after treatment initiation and time from treatment initiation to PSA nadir.","From treatment initiation up to 12 months",{"measure":22,"description":23,"timeFrame":24},"Utilization of imaging modalities for primary staging","Type and frequency of imaging modalities used at primary staging, including PSMA PET\u002FCT, conventional CT, bone scintigraphy, and MRI.","At baseline",{"measure":26,"description":27,"timeFrame":28},"Time to clinical progression","Time from treatment initiation to clinical progression, defined as local progression, and\u002For symptomatic skeletal events (pain, fracture, spinal cord compression), or initiation of surgery or radiotherapy for progression.","From treatment initiation through study completion, up to 4 years",{"measure":30,"description":31,"timeFrame":28},"Time to biochemical progression","Time from treatment initiation to biochemical progression per PCWG3 criteria, defined as a minimum PSA rise of 25% AND an absolute increase of 2ng\u002FmL from the nadir, confirmed on two measurements ≥3 weeks apart.",{"measure":33,"description":34,"timeFrame":28},"Time to radiographic progression","Time from treatment initiation to radiographic progression based on imaging (conventional imaging, PSMA PET\u002FCT), or RECIST 1.1 criteria.",{"measure":36,"description":37,"timeFrame":28},"Time to castration-resistant prostate cancer (CRPC)","Time from treatment initiation to castration-resistant prostate cancer (CRPC) per PCWG3 criteria.",{"measure":39,"description":40,"timeFrame":12},"Overall survival","Time from diagnosis to death from any cause.",{"measure":42,"description":43,"timeFrame":28},"Adverse events","Type, grade, and treatment-relatedness of adverse events occurring during treatment, graded according to the Common Terminology Criteria for Adverse Events version 5.0.",{"measure":45,"description":46,"timeFrame":28},"Number of hospital admissions","Total number of planned and unplanned hospital admissions.",{"measure":48,"description":49,"timeFrame":28},"Number of outpatient visits","Total number of outpatient visits",[51,55,59,63,67,70,73],{"measure":52,"description":53,"timeFrame":54},"Dynamic change in ctDNA fraction","Change in ctDNA fraction at 4-6 weeks and 9 months after start of initial treatment.","Change from baseline at 4-6 weeks, and 9 months after start of initial treatment.",{"measure":56,"description":57,"timeFrame":58},"Prevalence and clinical phenotypes of genomic alterations","Prevalence and clinical phenotype associations of somatic alterations in prostate cancer related genes and (likely) pathogenic germline variants, detected by cfDNA or tumor tissue.","At diagnosis or at disease progression, up to 4 years",{"measure":60,"description":61,"timeFrame":62},"Health-Related Quality of Life (Global Health Status)","Clinically meaningful change in Global Health Status using the EORTC QLQ-C30 as a measure for Health Related Quality of Life, from baseline to sequential follow-up.","Change from baseline at 3, 6, 9, 12, 18, 24, 30, 36, and 48 months.",{"measure":64,"description":65,"timeFrame":66},"Health-Related Quality of Life (Health Utility)","Change in health utility index and EQ Visual Analogue Scale score measured using the EQ-5D-5L, across five domains: mobility, self-care, usual activities, pain\u002Fdiscomfort, and anxiety\u002Fdepression.","Change from baseline at 3, 6, 9, 12, 18, 24, 30, 36, and 48 months",{"measure":68,"description":69,"timeFrame":62},"Pain intensity and interference","Change in average pain score and pain interference score measured using the Brief Pain Inventory - Short Form (BPI-SF).",{"measure":71,"description":72,"timeFrame":62},"Fatigue severity and interference","Change in average fatigue score and fatigue interference score measured using the Brief Fatigue Inventory (BFI).",{"measure":74,"description":75,"timeFrame":62},"Prostate cancer-specific symptoms","Change in prostate cancer-specific symptoms measured using the EORTC QLQ-PR25, domain scores for urinary symptoms, bowel symptoms, hormonal treatment-related symptoms, sexual activity, and sexual functioning.",null,{"allocation":76,"interventionModel":76,"interventionModelDescription":76,"primaryPurpose":76,"observationalModel":78,"timePerspective":79,"maskingInfo":76},"COHORT","PROSPECTIVE","All patients with treatment-naive high-risk localized and treatment-naive metastatic prostate carcinoma will be eligible to participate. These patients are identified by their treating physicians in all participating hospitals.",{"type":82,"investigatorFullName":76,"investigatorTitle":76,"investigatorAffiliation":76,"oldNameTitle":76,"oldOrganization":76},"SPONSOR","100636058",false,"NCT07560748","Prospective Prostate Cancer Infrastructure","ProPCI","Inclusion Criteria:\n\n* Diagnosis of either: high-risk localized prostate cancer (any of the following: PSA \\> 20 ng\u002FmL, ISUP Grade Group 4 or 5, or clinical stage ≥ T2c); or metastatic prostate cancer confirmed by imaging (CT, bone scintigraphy, PSMA PET\u002FCT, or (whole-body) MRI in combination with tumor markers (PSA)), or by biopsy of a metastatic lesion histopathologically deemed to be of prostatic origin.\n* Prostate adenocarcinoma (our main focus). We will allow the inclusion of adenocarcinoma with mixed small- or large-cell neuroendocrine prostate\n* Age ≥ 18 years at the time of inclusion.\n* Written informed consent\n* Able to understand one of the following languages sufficiently: Dutch, English, Arabic or Turkish.\n\nExclusion Criteria:\n\n* Not currently living in the Netherlands.","MALE","18 Years",{"count":92,"type":93},700,"ESTIMATED","48 Months","OBSERVATIONAL","The goal of this observational study is to collect detailed long-term real-world data and biomaterials from men with high-risk localized prostate cancer and synchronous metastatic hormone-sensitive prostate cancer. This will help to better understand how these patients are treated in daily practice, how treatments affect quality of life, and facilitate biomarker discovery. The infrastructure is also designed to enable future cohort multiple randomized controlled trials.",[98,99],"High Risk Localized Prostate Cancer","Synchronous Metastatic Hormone-Sensitive Prostate Cancer","NOT_YET_RECRUITING","2026-04-28",{"date":103,"type":104},"2026-05-01","ACTUAL",{"date":106,"type":93},"2026-05",{"date":108,"type":93},"2030-05",{"name":5,"class":6}]