[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100490744":3},{"organization":4,"armGroups":7,"interventions":16,"overallOfficials":34,"centralContacts":29,"locations":38,"responsibleParty":153,"collaborators":29,"id":155,"slug":156,"hasResults":157,"nctId":158,"briefTitle":159,"officialTitle":160,"acronym":29,"eligibilityCriteria":161,"healthyVolunteers":157,"sex":162,"minAge":163,"maxAge":164,"enrollmentInfo":165,"targetDuration":29,"studyType":168,"phases":169,"briefSummary":171,"conditions":172,"keywords":174,"overallStatus":187,"whyStopped":29,"lastUpdateSubmitDate":188,"lastUpdatePostDateStruct":189,"startDateStruct":191,"completionDateStruct":193,"leadSponsor":195,"locationsCount":196},{"fullName":5,"class":6},"Novartis","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"[177Lu]Lu-PSMA-617 plus best supportive\u002Fbest standard of care (BS\u002FBSOC)","EXPERIMENTAL","Patients will receive the investigational product 7.4 GBq (+\u002F- 10%) 177Lu-PSMA-617 intravenously every 6 weeks (+\u002F- 1 week) for a maximum of 6 cycles. Best supportive\u002Fbest standard of care (BS\u002FBSOC) may be used",[13,14,15],"Drug: [177Lu]Lu-PSMA-617","Other: Best supportive\u002Fbest standard of care (BS\u002FBSOC)","Drug: 68Ga-PSMA-11",[17,24,30],{"type":18,"name":19,"description":20,"armGroupLabels":21,"otherNames":22},"DRUG","[177Lu]Lu-PSMA-617","Administered intravenously once every 6 weeks (1 cycle) for a maximum of 6 cycles.",[9],[23],"AAA617",{"type":25,"name":26,"description":27,"armGroupLabels":28,"otherNames":29},"OTHER","Best supportive\u002Fbest standard of care (BS\u002FBSOC)","Best supportive\u002Fbest standard of care as defined by the local investigator",[9],null,{"type":18,"name":31,"description":32,"armGroupLabels":33,"otherNames":29},"68Ga-PSMA-11","Administered single intravenous dose of approximately 150 MBq. Administered dose could not be lower than 111 MBq or higher than 259 MBq (3 - 7 mCi).",[9],[35],{"name":36,"affiliation":36,"role":37},"Novartis Pharmaceuticals","STUDY_DIRECTOR",[39,52,61,66,75,84,89,93,95,104,112,117,122,127,135,140,145],{"facility":40,"status":29,"city":41,"state":42,"zip":43,"country":44,"countryCode":45,"cosmosGeoPoint":46,"geoPoint":51,"contacts":29},"Novartis Investigative 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Study to Evaluate the Efficacy, Safety, Pharmacokinetics and Dosimetry of [177Lu]Lu-PSMA-617 in Chinese Adult Male Patients With Progressive PSMA-Positive mCRPC","A Prospective, Open-label, Multi-center, Single-arm, Phase II Study to Evaluate the Efficacy, Safety, Pharmacokinetics and Dosimetry of [177Lu]Lu-PSMA-617 in Chinese Adult Male Patients With Progressive PSMA-Positive Metastatic Castration-Resistant Prostate Cancer (mCRPC)","Inclusion Criteria:\n\n* Written informed consent must be obtained before any assessment is performed.\n* Participants must be Chinese male adults \\>= 18 years of age.\n* Participants must have histological, pathological, and\u002For cytological confirmation of prostate cancer.\n* Participants must be \\[68Ga\\]Ga-PSMA-11 PET\u002FCT scan positive, and eligible as determined by the sponsor's central reader according to the VISION read rules.\n* Participants must have a castrate level of serum\u002Fplasma testosterone (\\\u003C 50 ng\u002Fdl, or \\\u003C 1.7 nmol\u002FL).\n* Participants must have received at least one ARPI (such as enzalutamide and\u002Forabiraterone).\n* Participants must have been previously treated with at least 1, but no more than 2 previous taxane regimens.\n\n  * A taxane regimen is defined as a minimum exposure of 2 cycles of a taxane. If a participant has received only 1 taxane regimen, the participant is eligible if: the participants' physician deems him unsuitable to receive a second taxane regimen (e.g., frailty assessed by geriatric or health status evaluation or intolerance, etc.)\n* Documented progressive mCRPC, based on at least 1 of the following criteria:\n\n  * Serum\u002Fplasma PSA progression defined as 2 consecutive increases in PSA measured at least 1 week apart, the minimal start value is 2.0 ng\u002Fml\n  * Soft-tissue progression defined based on PCWG3-modified RECIST v1.1 (Eisenhauer et al 2009, Scher et al 2016)\n  * Progression of bone disease: two new lesions; only positivity on the bone scan defines metastatic disease to bone (PCWG3 criteria (Scher et al 2016)\n* Participants must have \\>= 1 metastatic lesion that is present on baseline CT, MRI or bone scan imaging obtained =\\\u003C 21 days prior to enrollment via central reading.\n\n  * In main part: participant must have at least one measurable lesion by PCWG3-modified RECIST v1.1 via central reading\n* Participants must have adequate organ function:\n\n  * Bone marrow reserve:\n  * White blood cell (WBC) count \\>= 2.5 × 109\u002FL OR absolute neutrophil count (ANC) \\>= 1.5 × 109\u002FL\n  * Platelets \\>=100 × 109\u002FL\n  * Hemoglobin \\>= 9 g\u002FdL\n  * Hepatic:\n  * Total bilirubin =\\\u003C 1.5 x the institutional upper limit of normal (ULN). For participants with known Gilbert's Syndrome =\\\u003C 3 × ULN is permitted\n  * Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) =\\\u003C 3.0 × ULN OR =\\\u003C 5.0 × ULN for participants with liver metastases\n  * Renal:\n  * eGFR \\>= 50 mL\u002Fmin\u002F1.73m2 using the Modification of Diet in Renal Disease (MDRD) equation\n* Albumin \\>3.0 g\u002FdL.\n\nExclusion Criteria:\n\n* Previous treatment with Strontium-89, Samarium-153, Rhenium-186, Rhenium-188, Radium-223 or hemi-body irradiation.\n* Previous PSMA-targeted radioligand therapy.\n* Any systemic anti-cancer therapy (e.g. chemotherapy, immunotherapy or biological therapy \\[including monoclonal antibodies\\], APRI is not included) within 28 days prior to day of enrollment.\n* Any investigational agents (e.g. poly adenosine diphosphate-ribosyl polymerase inhibitors \\[PARPi\\]) within 28 days prior to day of enrollment.\n* History of hypersensitivity to any of the study drugs or its excipients or to drugs of similar chemical classes.\n* Other concurrent cytotoxic chemotherapy, immunotherapy, radioligand therapy, or investigational therapy.\n* Transfusion for the sole purpose of making a subject eligible for study inclusion.\n* Participants with a history of central nervous system (CNS) metastases who are neurologically unstable, symptomatic, or receiving corticosteroids for the purpose of maintaining neurologic integrity.\n\n  * Participants with CNS metastases are eligible if received therapy (surgery, radiotherapy, gamma knife), asymptomatic and neurologically stable without corticosteroids.\n  * Participants with epidural disease, canal disease and prior cord involvement are eligible if those areas have been treated, are stable, and not neurologically impaired.\n* Symptomatic spinal cord compression, or clinical or radiologic findings indicative of impending cord compression.","MALE","18 Years","100 Years",{"count":166,"type":167},62,"ACTUAL","INTERVENTIONAL",[170],"PHASE2","The purpose of this study was to assess the efficacy, safety, tolerability, Pharmacokinetic(s) (PK) and dosimetry of \\[177Lu\\]Lu-PSMA-617 when administered in addition to Best Supportive\u002FBest Standard of Care (BSC\u002FBSoC) in Chinese participants with progressive PSMA-positive mCRPC who received at least 1 novel androgen receptor pathway inhibitor (ARPI) and were previously treated with 1 to 2 taxane regimens. Furthermore, the safety, PK, and dosimetry of \\[68Ga\\]Ga-PSMA-11 were assessed.\n\nData from this study will be used to bridge global pivotal phase III study (VISION, AAA617A12301) and to support China registration of \\[177Lu\\]Lu-PSMA-617 as a novel anticancer modality, namely radioligand therapy, in mCRPC.",[173],"Metastatic Castration-Resistant Prostate Cancer (mCRPC)",[175,176,23,19,177,178,179,180,181,182,183,184,185,186],"Chinese adult male population","therapeutic agent lutetium (177Lu) vipivotide tetraxetan","radiolabeled compound gallium (68Ga) gozetotide","[68Ga]Ga-PSMA-11","Progressive PSMA-Positive Metastatic Castration-Resistant Prostate Cancer","Overall Response Rate","ORR","Prostate-specific Membrane Antigen","PSMA","Taxane","Androgen Receptor Pathway Inhibitor","ARPI","COMPLETED","2026-06-04",{"date":190,"type":167},"2026-06-08",{"date":192,"type":167},"2023-05-16",{"date":194,"type":167},"2026-04-22",{"name":36,"class":6},17]