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City","83301","Taiwan","TW",{"type":63,"coordinates":789},[790,791],120.31333,22.61626,{"lat":791,"lon":790},{"facility":400,"status":56,"city":794,"state":37,"zip":795,"country":786,"countryCode":787,"cosmosGeoPoint":796,"geoPoint":800,"contacts":37},"Tainan","704302",{"type":63,"coordinates":797},[798,799],120.21333,22.99083,{"lat":799,"lon":798},{"type":802,"investigatorFullName":37,"investigatorTitle":37,"investigatorAffiliation":37,"oldNameTitle":37,"oldOrganization":37},"SPONSOR","100592294","phase-2-an-open-label-study-of-jsb462-luxdegalutamide-in-combination-with-abiraterone-in-adult-male-patients-with-metastatic-hormone-sensitive-prostate-cancer-mhspc-100592294",false,"NCT06991556","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)","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.","MALE","18 Years",{"count":813,"type":814},150,"ESTIMATED","INTERVENTIONAL",[817],"PHASE2","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",[820],"Metastatic Hormone-sensitive Prostate Cancer",[822,823,824,28,32,825,826,827,828,829],"Interventional","clinical trial","open-label","efficacy","safety","tolerability","abiraterone","metastatic hormone-sensitive prostate cancer","2026-06-09",{"date":832,"type":833},"2026-06-10","ACTUAL",{"date":835,"type":833},"2025-07-07",{"date":837,"type":814},"2035-10-19",{"name":44,"class":6},67]