[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100654303":3},{"organization":4,"outcomesModule":7,"designInfo":14,"detailedDescription":13,"studyPopulation":13,"armGroups":21,"interventions":28,"overallOfficials":34,"centralContacts":39,"locations":44,"responsibleParty":62,"collaborators":13,"id":66,"slug":67,"hasResults":68,"nctId":69,"briefTitle":70,"officialTitle":71,"acronym":72,"eligibilityCriteria":73,"healthyVolunteers":68,"sex":74,"minAge":75,"maxAge":13,"enrollmentInfo":76,"targetDuration":13,"studyType":79,"phases":80,"briefSummary":82,"conditions":83,"keywords":85,"overallStatus":46,"whyStopped":13,"lastUpdateSubmitDate":88,"lastUpdatePostDateStruct":89,"startDateStruct":92,"completionDateStruct":94,"leadSponsor":96,"locationsCount":97},{"fullName":5,"class":6},"Affiliated Hospital of Jiangnan University","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":13},[9],{"measure":10,"description":11,"timeFrame":12},"Outcome Measure：Percentage of Participants With Confirmed PSA Response (≥50% PSA Decline)","Proportion of participants achieving confirmed ≥50% PSA reduction from baseline according to PCWG3 criteria. Confirmation requires a second PSA measurement at least 4 weeks later sustaining ≥50% decline.","From first study drug administration up to 12 weeks post-treatment",null,{"allocation":15,"interventionModel":16,"interventionModelDescription":17,"primaryPurpose":18,"observationalModel":13,"timePerspective":13,"maskingInfo":19},"NA","SINGLE_GROUP","Single-arm open-label study. All enrolled participants will receive SRT-017 radioligand therapy. No control group.","TREATMENT",{"masking":20,"maskingDescription":13,"whoMasked":13},"NONE",[22],{"label":23,"type":24,"description":25,"interventionNames":26},"SRT-017-001 Radioligand Therapy Group","EXPERIMENTAL","Male patients with metastatic castration-resistant prostate cancer (mCRPC) will receive investigational PSMA-targeted radiopharmaceutical SRT-017-001 by intravenous injection according to the study protocol.",[27],"Drug: SRT-017",[29],{"type":30,"name":31,"description":32,"armGroupLabels":33,"otherNames":13},"DRUG","SRT-017","Investigational PSMA-targeted radiopharmaceutical, administered intravenously for male patients with metastatic castration-resistant prostate cancer (mCRPC). Dosing and administration will follow the study protocol.",[23],[35],{"name":36,"affiliation":37,"role":38},"chunjing yu, MD","The Affiliated Hospital of Jiangnan University","STUDY_CHAIR",[40],{"name":36,"role":41,"phone":42,"phoneExt":13,"email":43},"CONTACT","+86 15312238622","ycj_wxd1978@163.com",[45],{"facility":5,"status":46,"city":47,"state":48,"zip":49,"country":50,"countryCode":51,"cosmosGeoPoint":52,"geoPoint":57,"contacts":58},"RECRUITING","Wuxi","Jiangsu","214000","China","CN",{"type":53,"coordinates":54},"Point",[55,56],120.28857,31.56887,{"lat":56,"lon":55},[59],{"name":60,"role":41,"phone":61,"phoneExt":13,"email":43},"Chunjing Yu, Doctor","+86 0510-68088861",{"type":63,"investigatorFullName":64,"investigatorTitle":65,"investigatorAffiliation":5,"oldNameTitle":13,"oldOrganization":13},"PRINCIPAL_INVESTIGATOR","Chunjing Yu","Chief Physician, Department of Nuclear Medicine","100654303","early-phase-1-clinical-evaluation-of-srt-017-in-patients-with-psma-positive-metastatic-castration-resistant-prostate-cancer-100654303",false,"NCT07798778","Clinical Evaluation of SRT-017 in Patients With PSMA-Positive Metastatic Castration-Resistant Prostate Cancer","To Evaluate the Safety, Tolerability, Radiation Dosimetry, Pharmacokinetics, and Preliminary Antitumor Efficacy of SRT-017 in Patients With PSMA-Positive Metastatic Castration-Resistant Prostate Cancer (mCRPC)","SRT-017-001","Inclusion Criteria:\n\n* Male participants aged 18 years or older.\n* Histologically or cytologically confirmed prostate adenocarcinoma with metastatic castration-resistant prostate cancer (mCRPC). mCRPC is defined as disease progression under continuous androgen-deprivation therapy (ADT) or after prior bilateral orchiectomy, with serum testosterone maintained at castrate level (\\\u003C50 ng\u002FdL or \\\u003C1.7 nmol\u002FL), meeting at least one of the Prostate Cancer Working Group 3 (PCWG3) progression criteria: PSA progression (PSA ≥1 ng\u002FmL, ≥25 % increase compared with PSA nadir with an absolute rise ≥2 ng\u002FmL confirmed by two consecutive measurements at least 1 week apart); or radiographic progression (≥2 new bone metastatic lesions on bone scan, or soft-tissue disease progression per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1)).\n* Disease progression after treatment with at least one novel androgen-axis drug (NAAD), including abiraterone, enzalutamide, apalutamide, or darolutamide.\n* Prior chemotherapy, or participants who are ineligible for chemotherapy or decline chemotherapy.\n* PSMA-positive lesions confirmed by PSMA-PET\u002FCT imaging; PSMA-positive is defined as tumor lesion uptake higher than liver background uptake.\n* At least one measurable lesion by RECIST 1.1 criteria OR at least one bone metastasis lesion by PCWG3 criteria.\n* Eastern Cooperative Oncology Group (ECOG) performance status score ≤ 1.\n* Estimated life expectancy of at least 6 months.\n* No transfusion of blood products, hematopoietic growth factors, or albumin within 14 days before baseline laboratory tests, and adequate organ function as follows: hematologic: absolute neutrophil count ≥ 1.5 × 10⁹\u002FL, white blood cell count ≥ 3.0 × 10⁹\u002FL, platelet count ≥ 100 × 10⁹\u002FL, hemoglobin ≥ 9 g\u002FdL; hepatic: albumin ≥ 30 g\u002FL, total bilirubin ≤ 1.5 × upper limit of normal (ULN), alanine aminotransferase (ALT) \u002F aspartate aminotransferase (AST) ≤ 3 × ULN (without liver metastases) or ALT\u002FAST ≤ 5 × ULN (with liver metastases); renal: serum creatinine ≤ 1.5 × ULN; coagulation: international normalized ratio (INR) ≤ 1.5, activated partial thromboplastin time (APTT) ≤ 2 × ULN.\n* Willing to comply with radiation-protection instructions and scheduled study follow-up procedures.\n* Able to understand study procedures and voluntarily provide written informed consent, and willing to comply with all study-related assessments and follow-up requirements.\n\nExclusion Criteria:\n\n* Participants unable to tolerate required imaging examinations.\n* Received systemic anti-tumor therapy (chemotherapy, radiotherapy, immunotherapy; endocrine therapy is exempt), investigational medicinal products, or investigational medical devices within 4 weeks prior to first study drug administration.\n* Received prior radiopharmaceutical therapy (such as strontium-89, samarium-153, rhenium-186, rhenium-188, radium-223, lutetium-177) within 6 months before first dose; or received external-beam radiation therapy (EBRT) within 2 months before first dose.\n* Persistent Grade 4 myelosuppression from prior anti-cancer therapy within 2 weeks before screening, or Grade 3 myelosuppression with recovery duration longer than 6 weeks.\n* Plan to receive cytotoxic chemotherapy, anti-tumor immunotherapy, radioligand therapy, or other similar anti-cancer treatments during study participation.\n* Known brain metastases identified at screening.\n* History of other malignant neoplasms within the past 5 years (curative-treated localized tumors such as basal-cell or squamous-cell skin cancer are permitted).\n* Symptomatic or impending spinal cord compression.\n* Prior external-beam radiation therapy covering more than 25 % of bone-marrow-containing skeletal regions.\n* Significant uncontrolled cardiovascular disease at screening: QTcF \\> 470 ms or known long QT syndrome; myocardial infarction, angina pectoris, or coronary artery bypass graft (CABG) within 6 months before screening and judged unsuitable for study entry by investigator.\n* Uncontrolled bladder-outlet obstruction, urinary incontinence, claustrophobia, or radiophobia at screening.\n* Positive screening serology for hepatitis C virus (HCV) antibody, human immunodeficiency virus (HIV) antibody, or syphilis antibody.\n* Hepatitis B surface antigen (HBsAg) positive with active hepatitis B virus (HBV) replication as assessed by HBV-DNA testing and investigator judgment.\n* Known hypersensitivity to proteins\u002Fpeptides, drug excipients, or structurally related compounds.\n* Documented history of drug or alcohol abuse or chronic substance dependence within 1 year prior to screening.\n* Unwilling to practice effective contraception during study participation and for 6 months after last study drug administration.\n* Severe active ongoing infection at the time of first planned study drug administration.\n* Any other medical condition which, in the investigator's judgment, may compromise participant safety, interfere with study result interpretation, or confer unacceptable participant risk.","MALE","18 Years",{"count":77,"type":78},18,"ESTIMATED","INTERVENTIONAL",[81],"EARLY_PHASE1","This is a single-arm, open-label study to evaluate the safety, tolerability and preliminary anti-tumor efficacy of SRT-017 radioligand therapy in patients with PSMA-Positive Metastatic Castration-Resistant Prostate Cancer (mCRPC). All eligible participants will receive SRT-017 intravenous treatment. The primary objectives are to assess safety and tolerability. Secondary objectives include radiation dosimetry, pharmacokinetics, and preliminary antitumor activity.",[84],"Metastatic Castration-Resistant Prostate Cancer",[84,86,87],"PSMA","Radioligand Therapy","2026-08-28",{"date":90,"type":91},"2026-09-01","ACTUAL",{"date":93,"type":91},"2026-07-30",{"date":95,"type":78},"2028-12-31",{"name":5,"class":6},1]