[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06991556":3,"trial-entities:NCT06991556":603,"trial-summary:NCT06991556":607},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":20,"study_type":31,"primary_purpose":32,"phases":33,"enrollment_info":35,"interventions":38,"primary_outcomes":55,"secondary_outcomes":69,"sex":124,"minimum_age":125,"maximum_age":126,"healthy_volunteers":127,"eligibility_criteria":128,"std_ages":138,"locations":141,"central_contacts":597,"overall_officials":598,"references":601,"see_also_links":602},"NCT06991556","CJSB462C12201","An Open-label Study of JSB462 (Luxdegalutamide) in Combination With Abiraterone in Adult Male Patients With Metastatic Hormone-sensitive Prostate Cancer (mHSPC)","A Phase II, Randomized, Open-label, Multi-center Study of JSB462 (Luxdegalutamide) in Combination With Abiraterone in Adult Male Patients With Metastatic Hormone-sensitive Prostate Cancer (mHSPC)","ACTIVE_NOT_RECRUITING","2035-09-04","2026-08","2026-08-25","2025-07-07","Novartis Pharmaceuticals","INDUSTRY",true,"This Phase II study aims to evaluate efficacy and safety of the combination of JSB462 (also known as luxdegalutamide) at 100 mg and 300 mg once a day (QD) doses + abiraterone compared with an androgen receptor pathway inhibitor (ARPI, abiraterone or enzalutamide) in participants with metastatic Hormone Sensitive Prostate Cancer (mHSPC) and to select the recommended dose of the combination for phase III. Towards that end, the totality of the efficacy, safety, tolerability and PK data from participants randomized in the study will be evaluated","The study for each participant consists of a Screening period (28 days), a treatment period, a post-treatment safety follow-up (30 days) followed by a long-term follow-up period.\n\nDuring the treatment period:\n\n* JSB462 is administered from randomization, orally, daily and continuously (100 mg or 300 mg QD) until disease progression per PCWG3-modified RECIST 1.1 as assessed by the investigator, the occurrence of unacceptable toxicities, death, participant decision or investigator decision.\n* Abiraterone 1000 mg or enzalutamide 160 mg are administered from randomization, orally, daily, and continuously until disease progression per PCWG3-modified RECIST 1.1 as assessed by the investigator, the occurrence of unacceptable toxicities, death, participant decision or investigator decision.\n\nDuring the post-treatment follow up period:\n\n* Safety follow-Up: After discontinuation of study treatment, all participants will be followed for at least 1 safety follow-up visit (30 days \\[+\u002F- 7 days\\] after treatment discontinuation). Subsequent lines of therapy may be administered according to investigator's discretion after treatment discontinuation.\n* Long-term follow-up: Starts after the Safety follow-up period and lasts until the end of study. Safety, efficacy and survival information may be collected from participants during this period.",[19],"Metastatic Hormone-sensitive Prostate Cancer",[21,22,23,24,25,26,27,28,29,30],"Interventional","clinical trial","open-label","JSB462","luxdegalutamide","efficacy","safety","tolerability","abiraterone","metastatic hormone-sensitive prostate cancer","INTERVENTIONAL","TREATMENT",[34],"PHASE2",{"count":36,"type":37},166,"ACTUAL",[39,46,51],{"type":40,"name":24,"description":41,"armGroupLabels":42,"otherNames":45},"DRUG","JSB462 is administered orally, daily and continuously (100 mg or 300 mg QD) until disease progression per PCWG3-modified RECIST 1.1 as assessed by the investigator, the occurrence of unacceptable toxicities, death, participant decision or investigator decision.",[43,44],"Arm 1","Arm 2",[25],{"type":40,"name":47,"description":48,"armGroupLabels":49},"Abiraterone","Abiraterone 1000 mg is administered orally, daily and continuously until disease progression per PCWG3-modified RECIST 1.1 as assessed by the investigator, the occurrence of unacceptable toxicities, death, participant decision or investigator decision.",[43,44,50],"Arm 3",{"type":40,"name":52,"description":53,"armGroupLabels":54},"Enzalutamide","Enzalutamide 160 mg is administered orally, daily and continuously until disease progression per PCWG3-modified RECIST 1.1 as assessed by the investigator, the occurrence of unacceptable toxicities, death, participant decision or investigator decision.",[50],[56,60,63,66],{"measure":57,"description":58,"timeFrame":59},"Prostate Specific Antigen 90 (PSA90) Rate","Prostate Specific Antigen 90 (PSA90) Rate is defined as the proportion of participants who achieve a ≥90% decrease in PSA from baseline at any timepoint, confirmed by a second PSA measurement ≥3 weeks without any PSA progression in between.","From date of randomization till 30 days safety fup, assessed up to approximately 75 months",{"measure":61,"description":62,"timeFrame":59},"Incidence rate of adverse events (AEs)","The analysis of adverse events will include categorization by type, frequency, and severity, as graded by the NCI CTCAE version 5.0.",{"measure":64,"description":65,"timeFrame":59},"Number of participants with dose adjustments","The number of participants with dose adjustments (reductions, interruption, or permanent discontinuation) will be summarized by treatment arm.",{"measure":67,"description":68,"timeFrame":59},"Duration of exposure to study treatment","The duration of exposure in weeks to study treatment and for each study treatment component (JSB462, abiraterone and enzalutamide) will be summarized for each study treatment component by means of descriptive statistics using the SAS.",[70,74,78,81,85,88,91,95,99,102,105,108,112,116,120],{"measure":71,"description":72,"timeFrame":73},"Radiographic Progression Free Survival (rPFS)","Radiographic Progression Free Survival (rPFS) is defined as the time between randomization and the first occurrence of disease progression (per PCWG3-modified RECIST 1.1 as assessed by the investigator) or death due to any cause","From date of randomization until date of radiographic progression or date of death from any cause, whichever comes first, assessed up to approximately 83 months",{"measure":75,"description":76,"timeFrame":77},"Overall Survival (OS)","Overall Survival (OS) is defined as the time between randomization and death due to any cause","From date of randomization until date of death from any cause, assessed up to approximately 83 months",{"measure":61,"description":79,"timeFrame":80},"The analysis of adverse events and laboratory abnormalities will include categorization by type, frequency, and severity, as graded by the NCI CTCAE version 5.0.","From date of randomization till 30 days safety fup, assessed up to approximately 83 months",{"measure":82,"description":83,"timeFrame":84},"Overall Response Rate (ORR)","Overall Response Rate (ORR) is defined as the proportion of participants achieving a confirmed complete response (CR) or partial response (PR) per PCWG3-modified RECIST 1.1 as assessed by the investigator","From date of randomization until date of progression or date of death from any cause, whichever come first, assessed up to approximately 83 months",{"measure":86,"description":87,"timeFrame":84},"Disease Control Rate (DCR)","Disease Control Rate (DCR) is defined as the proportion of participants achieving a CR, PR or stable disease (SD) per PCWG3-modified RECIST 1.1 as assessed by the investigator",{"measure":89,"description":90,"timeFrame":84},"Duration of Response (DOR)","Duration of Response (DOR) is defined as the time between first documented CR\u002FPR and disease progression or death due to any cause per PCWG3-modified RECIST 1.1 as assessed by the investigator",{"measure":92,"description":93,"timeFrame":94},"Time to Response (TTR)","Time to response (TTR) is defined as the time from randomization to the date of first documented CR or PR per PCWG3-modified RECIST 1.1 as assessed by the investigator","From date of randomization until date of first documented Complete Response (CR) or Partial Response (PR), assessed up to approximately 83 months",{"measure":96,"description":97,"timeFrame":98},"Time to soft tissue progression (TTSTP)","Time to soft tissue progression (TTSTP) is defined as the time from randomization to the date of first documented radiographic soft tissue progression per PCWG3-modified RECIST 1.1 as assessed by the investigator","From date of randomization until date of soft tissue radiographic progression or date of death from any cause, whichever comes first, assessed up to approximately 83 months",{"measure":100,"description":101,"timeFrame":59},"Prostate Specific Antigen 30 (PSA30) Rate","Prostate Specific Antigen 30 (PSA30) Rate is defined as the proportion of participants who achieve a ≥30% decrease from baseline at any timepoint, confirmed by a second PSA measurement ≥3 weeks without any PSA progression in between",{"measure":103,"description":104,"timeFrame":59},"Prostate Specific Antigen 50 (PSA50) Rate","Prostate Specific Antigen 50 (PSA50) Rate is defined as the proportion of participants who achieve a ≥50% decrease from baseline at any timepoint, confirmed by a second PSA measurement ≥3 weeks without any PSA progression in between",{"measure":106,"description":107,"timeFrame":59},"Prostate Specific Antigen 0 (PSA0) Rate","Prostate Specific Antigen 0 (PSA0) Rate is defined as the proportion of participants who achieve a PSA level \\\u003C0.2 ng\u002Fml at any timepoint after start of treatment, confirmed by a second PSA measurement ≥3 weeks without any PSA progression in between",{"measure":109,"description":110,"timeFrame":111},"Duration of biochemical response (DBR)","Duration of biochemical response (DBR) is defined as the time between PSA90 and\u002For PSA0 and PSA progression (increase ≥25% in PSA and an absolute increase of ≥2 ng\u002FmL from NADIR) or death due to any cause","From date of date of first PSA50 response until date of PSA progression or death from any cause, assessed up to approximately 83 months",{"measure":113,"description":114,"timeFrame":115},"Time to first symptomatic skeletal event (TTSSE)","Time to first symptomatic skeletal event (TTSSE) is defined as the date of randomization to the date of first new symptomatic pathological bone fracture, spinal cord compression, tumor-related orthopedic surgical intervention, requirement for radiation therapy to relieve bone pain or death from any cause, whichever occurs first","From date of randomization till EOT or death, whichever happens first, assessed up to approximately 83 months",{"measure":117,"description":118,"timeFrame":119},"Plasma concentrations of JSB462 and plasma concentrations of its metabolite ARV-767","JSB462 pharmacokinetic (PK) samples will be obtained and evaluated in all participants at all dose levels in JSB462 treatment arms.","Day 1 of Cycles 1 and 2: Pre-dose\u002F0h and Post-dose 4h +\u002F- 1h. Day 1 of Cycles 3 to 8: Pre-dose\u002F0h. End of Treatment Visit (EOT): Anytime. 1 cycle = 28 days.",{"measure":121,"description":122,"timeFrame":123},"Patient Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)","The PRO-CTCAE is a patient-reported outcomes measurement system developed by the National Cancer Institute as a companion to the CTCAE. It includes items covering participant-reported symptomatic adverse events (AEs) from the CTCAE. Each symptomatic AE concept has up to three items evaluating frequency, severity, or interference, focused on the study population and treatment regimens.\n\nParticipants respond on a 5-point scale for each item:\n\n* Frequency: Never, Rarely, Occasionally, Frequently, Almost constantly\n* Severity: None, Mild, Moderate, Severe, Very severe\n* Interference: Not at all, A little bit, Somewhat, Quite a bit, Very much\n\nThe past 7-day recall version is used, focusing on relevant symptoms like fatigue, diarrhea, and hot flashes.","From randomization up till 30 day safety Follow-up, assessed up to approximately 83 months","MALE","18 Years",null,false,{"inclusion":129,"exclusion":134,"raw_text":137},[130,131,132,133],"An Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) ≤2","Histologically confirmed adenocarcinoma of the prostate. Participants with mixed histology (neuroendocrine) are not eligible","High-volume mHSPC, defined by the presence of ≥1 metastatic visceral non-nodal lesion and\u002For ≥4 metastatic bone lesions (with at least one lesion outside the vertebral column and\u002For pelvis) in imaging exams (CT\u002FMRI or bone scan) according to local radiology assessment by the investigator obtained ≤28 days prior to randomization","Participants must have a castrate level of serum\u002Fplasma testosterone (\\\u003C50 ng\u002FdL or \\\u003C1.7 nmol\u002FL). Ongoing ADT (as defined by prior orchiectomy and\u002For ongoing GnRH analog\u002Fantagonist) for ≤90 days is allowed prior to randomization, provided that PSA zero (PSA level \\\u003C0.2 ng\u002Fml according to local laboratory as assessed by the investigator) is not achieved prior to randomization.",[135,136],"Prior exposure to a second generation ARPI (such as enzalutamide\u002Fdarolutamide\u002Fapalutamide and\u002For abiraterone) for the treatment of advanced\u002Fmetastatic disease is not allowed. Prior exposure to ARPI, to taxane chemotherapy (up to 6 cycles) or to RLT in the context of (neo)adjuvant treatment for localized prostate cancer is allowed, if the last dose of this treatment was administered \\>12 months from randomization. Prior use of a first generation ARPI (such as bicalutamide) in the context of ADT initiation with a GnRH analog is allowed, provided the first generation ARPI was administered for ≤14 days and last dose was administered ≥7 days from randomization.","Participants with biochemical recurrence only or those without evidence of metastatic disease by radiological imaging (CT\u002FMRI or bone scan) are not eligible","Key Inclusion Criteria:\n\n* An Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) ≤2\n* Histologically confirmed adenocarcinoma of the prostate. Participants with mixed histology (neuroendocrine) are not eligible\n* High-volume mHSPC, defined by the presence of ≥1 metastatic visceral non-nodal lesion and\u002For ≥4 metastatic bone lesions (with at least one lesion outside the vertebral column and\u002For pelvis) in imaging exams (CT\u002FMRI or bone scan) according to local radiology assessment by the investigator obtained ≤28 days prior to randomization\n* Participants must have a castrate level of serum\u002Fplasma testosterone (\\\u003C50 ng\u002FdL or \\\u003C1.7 nmol\u002FL). Ongoing ADT (as defined by prior orchiectomy and\u002For ongoing GnRH analog\u002Fantagonist) for ≤90 days is allowed prior to randomization, provided that PSA zero (PSA level \\\u003C0.2 ng\u002Fml according to local laboratory as assessed by the investigator) is not achieved prior to randomization.\n\nKey Exclusion Criteria:\n\n* Prior exposure to a second generation ARPI (such as enzalutamide\u002Fdarolutamide\u002Fapalutamide and\u002For abiraterone) for the treatment of advanced\u002Fmetastatic disease is not allowed. Prior exposure to ARPI, to taxane chemotherapy (up to 6 cycles) or to RLT in the context of (neo)adjuvant treatment for localized prostate cancer is allowed, if the last dose of this treatment was administered \\>12 months from randomization. Prior use of a first generation ARPI (such as bicalutamide) in the context of ADT initiation with a GnRH analog is allowed, provided the first generation ARPI was administered for ≤14 days and last dose was administered ≥7 days from randomization.\n* Participants with biochemical recurrence only or those without evidence of metastatic disease by radiological imaging (CT\u002FMRI or bone scan) are not eligible\n\nOther inclusion\u002Fexclusion criteria may apply.",[139,140],"ADULT","OLDER_ADULT",[142,151,158,166,174,182,190,198,206,214,222,229,236,243,251,258,266,274,282,290,297,305,314,321,329,336,342,350,357,364,372,375,382,388,394,402,408,414,420,428,434,440,446,454,461,468,475,482,490,497,503,509,516,522,528,534,537,540,547,550,558,565,572,578,584,591],{"facility":143,"city":144,"state":145,"zip":146,"country":147,"geoPoint":148},"University of California San Diego - Moores Cancer Center","La Jolla","California","92093-0658","United States",{"lat":149,"lon":150},32.84727,-117.2742,{"facility":152,"city":153,"state":145,"zip":154,"country":147,"geoPoint":155},"Saint Johns Cancer Institute","Santa Monica","90404",{"lat":156,"lon":157},34.01949,-118.49138,{"facility":159,"city":160,"state":161,"zip":162,"country":147,"geoPoint":163},"Rocky Mountain Cancer Centers","Denver","Colorado","80218",{"lat":164,"lon":165},39.73915,-104.9847,{"facility":167,"city":168,"state":169,"zip":170,"country":147,"geoPoint":171},"Yale Cancer Center","New Haven","Connecticut","06520",{"lat":172,"lon":173},41.30815,-72.92816,{"facility":175,"city":176,"state":177,"zip":178,"country":147,"geoPoint":179},"Advanced Urology Ins Daytona Beach","Daytona Beach","Florida","32114",{"lat":180,"lon":181},29.21081,-81.02283,{"facility":183,"city":184,"state":185,"zip":186,"country":147,"geoPoint":187},"Emory University School of Medicine-Winship Cancer Institute","Atlanta","Georgia","30322",{"lat":188,"lon":189},33.749,-84.38798,{"facility":191,"city":192,"state":193,"zip":194,"country":147,"geoPoint":195},"Associated Urological Specialists","Chicago Ridge","Illinois","60415",{"lat":196,"lon":197},41.70142,-87.77922,{"facility":199,"city":200,"state":201,"zip":202,"country":147,"geoPoint":203},"Mass General Hospital","Boston","Massachusetts","02114",{"lat":204,"lon":205},42.35843,-71.05977,{"facility":207,"city":208,"state":209,"zip":210,"country":147,"geoPoint":211},"Michigan Institute of Urology","West Bloomfield","Michigan","48322",{"lat":212,"lon":213},42.56891,-83.38356,{"facility":215,"city":216,"state":217,"zip":218,"country":147,"geoPoint":219},"XCancer Omaha LLC","Omaha","Nebraska","68130",{"lat":220,"lon":221},41.25626,-95.94043,{"facility":223,"city":224,"state":224,"zip":225,"country":147,"geoPoint":226},"Perlmutter Cancer Centre","New York","10016",{"lat":227,"lon":228},40.71427,-74.00597,{"facility":230,"city":231,"state":224,"zip":232,"country":147,"geoPoint":233},"Associated Med Professionals of NY","Syracuse","13210",{"lat":234,"lon":235},43.04812,-76.14742,{"facility":237,"city":238,"state":224,"zip":239,"country":147,"geoPoint":240},"Montefiore Medical Center","The Bronx","10467",{"lat":241,"lon":242},40.84985,-73.86641,{"facility":244,"city":245,"state":246,"zip":247,"country":147,"geoPoint":248},"MidLantic Urology","Bala-Cynwyd","Pennsylvania","19004",{"lat":249,"lon":250},40.00761,-75.23407,{"facility":252,"city":253,"state":246,"zip":254,"country":147,"geoPoint":255},"Fox Chase Cancer Center","Philadelphia","19111",{"lat":256,"lon":257},39.95238,-75.16362,{"facility":259,"city":260,"state":261,"zip":262,"country":147,"geoPoint":263},"Carolina Urologic Research Center","Myrtle Beach","South Carolina","29572",{"lat":264,"lon":265},33.68906,-78.88669,{"facility":267,"city":268,"state":269,"zip":270,"country":147,"geoPoint":271},"Tennessee Oncology","Nashville","Tennessee","37203",{"lat":272,"lon":273},36.16589,-86.78444,{"facility":275,"city":276,"state":277,"zip":278,"country":147,"geoPoint":279},"Urology San Antonio","San Antonio","Texas","78229",{"lat":280,"lon":281},29.42412,-98.49363,{"facility":283,"city":284,"state":285,"zip":286,"country":147,"geoPoint":287},"Inova Schar Cancer Institute","Fairfax","Virginia","22031",{"lat":288,"lon":289},38.84622,-77.30637,{"facility":291,"city":292,"state":285,"zip":293,"country":147,"geoPoint":294},"Virginia Oncology Associates","Norfolk","23502",{"lat":295,"lon":296},36.84681,-76.28522,{"facility":298,"city":299,"state":300,"zip":301,"country":147,"geoPoint":302},"Fred Hutch Cancer Research","Seattle","Washington","98109",{"lat":303,"lon":304},47.60621,-122.33207,{"facility":306,"city":307,"state":308,"zip":309,"country":310,"geoPoint":311},"Novartis Investigative Site","Adelaide","South Australia","5000","Australia",{"lat":312,"lon":313},-34.92866,138.59863,{"facility":306,"city":315,"state":316,"zip":317,"country":310,"geoPoint":318},"Clayton","Victoria","3168",{"lat":319,"lon":320},-37.91667,145.11667,{"facility":306,"city":322,"state":323,"zip":324,"country":325,"geoPoint":326},"Fortaleza","Ceará","60140-025","Brazil",{"lat":327,"lon":328},-3.71722,-38.54306,{"facility":306,"city":330,"state":331,"zip":332,"country":325,"geoPoint":333},"Porto Alegre","Rio Grande do Sul","90610-000",{"lat":334,"lon":335},-30.03283,-51.23019,{"facility":306,"city":337,"state":337,"zip":338,"country":325,"geoPoint":339},"São Paulo","01221-020",{"lat":340,"lon":341},-23.5475,-46.63611,{"facility":306,"city":343,"state":344,"zip":345,"country":346,"geoPoint":347},"Vancouver","British Columbia","V5Z 1M9","Canada",{"lat":348,"lon":349},49.24966,-123.11934,{"facility":306,"city":351,"state":352,"zip":353,"country":346,"geoPoint":354},"Halifax","Nova Scotia","B3H 2Y9",{"lat":355,"lon":356},44.64269,-63.57688,{"facility":306,"city":358,"state":359,"zip":360,"country":346,"geoPoint":361},"Montreal","Quebec","H4A 3J1",{"lat":362,"lon":363},45.50884,-73.58781,{"facility":306,"city":365,"state":366,"zip":367,"country":368,"geoPoint":369},"Beijing","Chaoyang","100021","China",{"lat":370,"lon":371},39.9075,116.39723,{"facility":306,"city":365,"zip":373,"country":368,"geoPoint":374},"100034",{"lat":370,"lon":371},{"facility":306,"city":376,"zip":377,"country":378,"geoPoint":379},"Brno","656 53","Czechia",{"lat":380,"lon":381},49.19522,16.60796,{"facility":306,"city":383,"zip":384,"country":378,"geoPoint":385},"Olomouc","779 00",{"lat":386,"lon":387},49.59552,17.25175,{"facility":306,"city":389,"zip":390,"country":378,"geoPoint":391},"Prague","150 06",{"lat":392,"lon":393},50.08804,14.42076,{"facility":306,"city":395,"state":396,"zip":397,"country":398,"geoPoint":399},"Nice","Alpes Maritimes","06189","France",{"lat":400,"lon":401},43.70313,7.26608,{"facility":306,"city":403,"zip":404,"country":398,"geoPoint":405},"Marseille","13273",{"lat":406,"lon":407},43.29695,5.38107,{"facility":306,"city":409,"zip":410,"country":398,"geoPoint":411},"Quint-Fonsegrives","31130",{"lat":412,"lon":413},43.5852,1.5272,{"facility":306,"city":415,"zip":416,"country":398,"geoPoint":417},"Suresnes","92150",{"lat":418,"lon":419},48.87143,2.22929,{"facility":306,"city":421,"state":422,"zip":423,"country":424,"geoPoint":425},"Düsseldorf","North Rhine-Westphalia","40225","Germany",{"lat":426,"lon":427},51.22319,6.77927,{"facility":306,"city":429,"zip":430,"country":424,"geoPoint":431},"Hamburg","20246",{"lat":432,"lon":433},53.55073,9.99302,{"facility":306,"city":435,"zip":436,"country":424,"geoPoint":437},"Lübeck","23538",{"lat":438,"lon":439},53.86893,10.68729,{"facility":306,"city":441,"zip":442,"country":424,"geoPoint":443},"Nürtingen","72622",{"lat":444,"lon":445},48.62565,9.34203,{"facility":306,"city":447,"state":448,"zip":449,"country":450,"geoPoint":451},"Asti","AT","14100","Italy",{"lat":452,"lon":453},44.90162,8.20751,{"facility":306,"city":455,"state":456,"zip":457,"country":450,"geoPoint":458},"Padova","PD","35128",{"lat":459,"lon":460},44.38225,11.14261,{"facility":306,"city":462,"state":463,"zip":464,"country":450,"geoPoint":465},"Trento","TN","38122",{"lat":466,"lon":467},46.06787,11.12108,{"facility":306,"city":469,"state":470,"zip":471,"country":450,"geoPoint":472},"Orbassano","TO","10043",{"lat":473,"lon":474},45.00547,7.53813,{"facility":306,"city":476,"state":477,"zip":478,"country":450,"geoPoint":479},"Verona","VR","37134",{"lat":480,"lon":481},45.43854,10.9938,{"facility":306,"city":483,"state":484,"zip":485,"country":486,"geoPoint":487},"Zwolle","Overijssel","8025 AB","Netherlands",{"lat":488,"lon":489},52.5125,6.09444,{"facility":306,"city":491,"state":492,"zip":493,"country":486,"geoPoint":494},"Dordrecht","South Holland","3318 AT",{"lat":495,"lon":496},51.81,4.67361,{"facility":306,"city":498,"zip":499,"country":486,"geoPoint":500},"Hoofddorp","2134 TM",{"lat":501,"lon":502},52.3025,4.68889,{"facility":306,"city":504,"zip":505,"country":486,"geoPoint":506},"Schiedam","3118 JH",{"lat":507,"lon":508},51.91917,4.38889,{"facility":306,"city":510,"zip":511,"country":512,"geoPoint":513},"Kielce","25-640","Poland",{"lat":514,"lon":515},50.87033,20.62752,{"facility":306,"city":517,"zip":518,"country":512,"geoPoint":519},"Oświęcim","32-600",{"lat":520,"lon":521},50.03437,19.21037,{"facility":306,"city":523,"zip":524,"country":512,"geoPoint":525},"Skorzewo","60-185",{"lat":526,"lon":527},54.16909,17.97006,{"facility":306,"city":529,"zip":530,"country":529,"geoPoint":531},"Singapore","119074",{"lat":532,"lon":533},1.28967,103.85007,{"facility":306,"city":529,"zip":535,"country":529,"geoPoint":536},"169608",{"lat":532,"lon":533},{"facility":306,"city":529,"zip":538,"country":529,"geoPoint":539},"308433",{"lat":532,"lon":533},{"facility":306,"city":541,"zip":542,"country":543,"geoPoint":544},"Seoul","03080","South Korea",{"lat":545,"lon":546},37.566,126.9784,{"facility":306,"city":541,"zip":548,"country":543,"geoPoint":549},"06351",{"lat":545,"lon":546},{"facility":306,"city":551,"state":552,"zip":553,"country":554,"geoPoint":555},"Santander","Cantabria","39008","Spain",{"lat":556,"lon":557},43.46589,-3.80493,{"facility":306,"city":559,"state":560,"zip":561,"country":554,"geoPoint":562},"Badajoz","Extremadura","06080",{"lat":563,"lon":564},38.87789,-6.97061,{"facility":306,"city":566,"state":567,"zip":568,"country":554,"geoPoint":569},"Lugo","Galicia","27003",{"lat":570,"lon":571},43.00992,-7.55602,{"facility":306,"city":573,"zip":574,"country":554,"geoPoint":575},"Barcelona","08036",{"lat":576,"lon":577},41.38879,2.15899,{"facility":306,"city":579,"zip":580,"country":554,"geoPoint":581},"Córdoba","14004",{"lat":582,"lon":583},37.89155,-4.77275,{"facility":306,"city":585,"zip":586,"country":587,"geoPoint":588},"Kaohsiung City","833","Taiwan",{"lat":589,"lon":590},22.61626,120.31333,{"facility":306,"city":592,"zip":593,"country":587,"geoPoint":594},"Tainan","704302",{"lat":595,"lon":596},22.99083,120.21333,[],[599],{"name":13,"affiliation":13,"role":600},"STUDY_DIRECTOR",[],[],{"nct_id":4,"conditions":604,"biomarkers":606},[605],"Prostate Carcinoma",[],{"nct_id":4,"found":15,"summary":608,"prompt_version":618},{"design":609,"status":610,"heading":611,"summary":612,"follow_up":613,"word_count":614,"commitments":615,"compensation":616,"drugs_mentioned":617},"This is an open-label study, meaning you and your doctors will know which treatment you are receiving. It aims to enroll 150 participants.","completed","JSB462 with Abiraterone for Metastatic Hormone-Sensitive Prostate Cancer","This study is testing JSB462 (also called luxdegalutamide) in combination with abiraterone for men with metastatic hormone-sensitive prostate cancer (mHSPC). This means the cancer has spread to other parts of the body but still responds to hormone therapy. Researchers want to see how safe and effective JSB462 is when added to abiraterone, compared to abiraterone or enzalutamide alone. The study will also help determine the best dose of JSB462 to use in future studies. Success will be measured by how much prostate-specific antigen (PSA) levels drop and by tracking any side effects. You may be eligible if you are an adult male with this type of prostate cancer and meet other health criteria.","After treatment ends, you will have a safety follow-up for 30 days. There will then be a long-term follow-up period that lasts until the end of the study, which could be up to approximately 75 months.",113,"You will have a screening period of up to 28 days, followed by a treatment period where you take JSB462 and abiraterone (or abiraterone or enzalutamide alone) daily by mouth. After treatment, there will be a safety follow-up for 30 days, then a long-term follow-up period.","Not stated in the trial record.",[24,47,52],"v2"]