[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"mhspc\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:mhspc":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,41,67],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":40},"100631645","phase-2-evaluation-of-the-efficacy-and-safety-of-darolutamide--adt-combined-with-low-dose-docetaxel-in-mhspc-100631645",false,"NCT07503379","Evaluation of the Efficacy and Safety of Darolutamide + ADT Combined With Low-dose Docetaxel in mHSPC","Evaluation of the Efficacy and Safety of Darolutamide + ADT Combined With Low-dose Docetaxel in mHSPC: a Multi-center, Prospective, Single-arm Study","LoDARO","Inclusion Criteria:\n\n1. Written informed consent\n2. Males ≥18 years of age\n3. Histologically or cytologically confirmed adenocarcinoma of prostate\n4. Metastatic disease documented either by a positive bone scan, or for soft tissue or visceral metastases, either by contrast-enhanced abdominal\u002Fpelvic\u002Fchest computed tomography (CT) or magnetic resonance imaging (MRI) scan assessed by Investigator and confirmed by central radiology review\n5. Subjects must be candidates for ADT and docetaxel therapy per Investigator's judgment\n6. Started ADT (LHRH agonist\u002Fantagonist or orchiectomy) with or without first generation anti-androgen, but no longer than 12 weeks before included. For subjects receiving LHRH agonists, treatment in combination with a first generation anti-androgen for at least 4 weeks before the initiation of study is recommended. First generation anti-androgen has to be stopped prior to included.\n7. An Eastern Cooperative Oncology Group performance status of 0 or 1\n\nExclusion Criteria:\n\n1\\. Prior treatment with:\n\n1. LHRH agonist\u002Fantagonists started more than 12 weeks before before the initiation of study\n2. Second-generation androgen receptor (AR) inhibitors such as enzalutamide, ARN-509, darolutamide, other investigational AR inhibitors\n3. Cytochrome P 17 enzyme inhibitor such as abiraterone acetate or oral ketoconazole as antineoplastic treatment for prostate cancer\n4. Chemotherapy or immunotherapy for prostate cancer prior to randomization 2. Treatment with radiotherapy (external beam radiation therapy, brachytherapy, or radiopharmaceuticals) within 2 weeks before initiation of study 3. Known hypersensitivity to any of the study drugs, study drug classes, or excipients in the formulation of the study drugs","MALE","18 Years",{"count":20,"type":21},109,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","This is a single-arm, prospective, multicenter, interventional study, aimed at exploring the efficacy and safety of darolutamide + ADT combined with low-dose docetaxel in treating patients with mHSPC planning to recruit approximately 109 patients.\n\nThe purpose of this study is to investigate the proportion of patients who reach PSA undetectable (PSA\\\u003C 0.2ng\u002Fml) at the primary analysis (24 weeks). According to the ARASENS study, the percentage of undetectable PSA in the experimental arm in the Chinese subset at 24 weeks is 46.2%. This study calculates that it is possible to maintain the therapeutic efficacy of PSA while reducing the dose of docetaxel.",[27],"mHSPC","NOT_YET_RECRUITING","2026-03-25",{"date":31,"type":32},"2026-03-31","ACTUAL",{"date":34,"type":21},"2026-04",{"date":36,"type":21},"2028-12",{"name":38,"class":39},"Yonghong Li","OTHER",2,{"id":42,"slug":43,"hasResults":11,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":4,"eligibilityCriteria":47,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":48,"enrollmentInfo":49,"targetDuration":4,"studyType":22,"phases":51,"briefSummary":53,"conditions":54,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":57,"lastUpdatePostDateStruct":58,"startDateStruct":60,"completionDateStruct":62,"leadSponsor":64,"locationsCount":66},"100622865","early-phase-1-safety-and-efficacy-evaluation-of-lc-k76-in-patients-with-metastatic-hormone-sensitive-prostate-cancer-100622865","NCT07389174","Safety and Efficacy Evaluation of LC-K76 in Patients With Metastatic Hormone-Sensitive Prostate Cancer","An Open-Label, Exploratory Study to Evaluate the Safety and Preliminary Efficacy of LC-K76 in Combination With Endocrine Therapy in Patients With Metastatic Hormone-Sensitive Prostate Cancer","Inclusion Criteria:\n\n1. Male, aged ≥ 18 years.\n2. Histologically or cytologically confirmed newly diagnosed metastatic hormone-sensitive prostate adenocarcinoma, without small cell carcinoma or small cell components.\n3. Presence of at least one bone metastasis or visceral metastasis (excluding lymph nodes) detected by systemic imaging (CT\u002FMRI).\n4. No prior treatment for prostate cancer before enrollment (including but not limited to radical surgery, radiotherapy, endocrine therapy, or chemotherapy).\n5. No history of allergy to dandelion or dandelion products.\n6. ECOG performance status ≤ 2.\n7. Plan to receive and maintain Androgen Deprivation Therapy (ADT) combined with an androgen receptor antagonist (e.g., enzalutamide, apalutamide, darolutamide), abiraterone acetate, or other drugs inhibiting testosterone synthesis during the study period.\n8. Subjects are able to comply with oral LC-K76 capsule administration and adhere to study requirements throughout the study\n\nExclusion Criteria:\n\n1. Lack of pathological evidence for prostate cancer diagnosis.\n2. Prior receipt of any treatment modality for prostate cancer.\n3. Patients with other primary malignant tumors that were progressive or required active treatment within the past 3 years.\n4. Patients with diabetes requiring continuous insulin therapy or poorly controlled diabetes.\n5. Known or suspected central nervous system metastases or active leptomeningeal disease.\n6. Significant abnormalities in bone marrow, coagulation, renal, and hepatic function, defined as laboratory values at randomization: Hemoglobin \\\u003C 90 g\u002FL, Neutrophils \\\u003C 1.5 × 10$\\^9$\u002FL, Platelets \\\u003C 75 × 10$\\^9$\u002FL, ALT \\> 2.5 × ULN, AST \\> 2.5 × ULN, or Serum Total Bilirubin \\> 1.5 × ULN; eGFR \\\u003C 60 mL\u002Fmin\u002F1.73m$\\^2$.\n7. Any severe disease affecting cardiopulmonary function or high-risk conditions.\n8. History of severe drug allergies.\n9. Presence of factors interfering with swallowing, chronic diarrhea, intestinal obstruction, or other factors affecting drug intake and absorption.\n10. Concurrent psychiatric illness or neurological symptoms judged to make participation difficult.\n11. Any condition that, in the judgment of the investigator, poses a severe safety risk to the patient, may confound study results, or may affect the patient's ability to complete the study (e.g., poorly controlled hypertension, severe diabetes, neurological or psychiatric disorders), or any other relevant conditions.\n12. Concurrent participation in other clinical trials or use of other investigational drugs.\n13. Refusal or inability to sign the informed consent form.","85 Years",{"count":50,"type":21},40,[52],"EARLY_PHASE1","This study is a single-centre, randomised, paired 24-week intervention dosing trial. Its purpose is to evaluate the safety profile and efficacy of the investigational drug in subjects with metastatic hormone-sensitive prostate cancer receiving oral LC-K76 treatment.\n\nFollowing a screening period not exceeding three weeks, subjects will enter a one- to two-week matching and randomization phase. Subsequently, subjects will be assigned to receive the study drug for a 24-week treatment period, followed by a 24-week follow-up period.",[27,55,56],"mHNPC","Prostate Cancer Adenocarcinoma","2026-02-03",{"date":59,"type":32},"2026-02-05",{"date":61,"type":21},"2026-02",{"date":63,"type":21},"2027-06",{"name":65,"class":39},"Shanghai Changzheng Hospital",1,{"id":68,"slug":69,"hasResults":11,"nctId":70,"briefTitle":71,"officialTitle":72,"acronym":4,"eligibilityCriteria":73,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":48,"enrollmentInfo":74,"targetDuration":4,"studyType":76,"phases":4,"briefSummary":77,"conditions":78,"keywords":81,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":84,"lastUpdatePostDateStruct":85,"startDateStruct":87,"completionDateStruct":89,"leadSponsor":91,"locationsCount":4},"100601601","minimal-residual-disease-used-in-predicting-therapeutic-efficacy-in-metastatic-hormone-sensitive-prostate-cancer-100601601","NCT07112612","Minimal Residual Disease Used in Predicting Therapeutic Efficacy in Metastatic Hormone-sensitive Prostate Cancer","Application of Personalized Minimal Residual Disease in Predicting Therapeutic Efficacy in Metastatic Hormone-sensitive Prostate Cancer","Inclusion Criteria:\n\n1. Aged 18 years and younger than 85 years;\n2. Patients diagnosed with prostate acinar adenocarcinoma, ductal adenocarcinoma, or intraductal carcinoma by pathological histology;\n3. Patients with clear distant metastases found by imaging (in accordance with RECIST criteria);\n4. Patients with locally advanced (N1) and metastatic (M1) prostate cancer at diagnosis.\n5. Patients who have not received endocrine therapy or other systemic anti-tumor treatments in the past;\n6. ECOG score of 0-2 points, with an expected survival period of more than 6 months;\n7. Patients with normal organ function;\n8. Routine blood test (no blood transfusion or blood products within 14 days):\n\n   Hemoglobin (HGB) ≥ 90g\u002FL; Absolute neutrophil count (ANC) ≥ 1.5×109\u002FL (1500 \u002Fmm3); Platelet count (PLT) ≥ 75×109\u002FL; White blood cell count (WBC) ≥ 3×109\u002FL;\n9. Biochemical examination:\n\n   Total bilirubin (TBIL) ≤ upper limit of normal (ULN); Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 ULN; Creatinine clearance (CCr) ≥ 30ml\u002Fmin; (Cockcroft-Gault formula);\n10. Coagulation function: prothrombin international normalized ratio (INR) ≤ 1.5 or prothrombin time (PT) \\\u003C 4 seconds;\n11. Patients agree to sign informed consent and are able to attend scheduled study visits, provide clinical information, and cooperate with other study procedures.\n\nExclusion Criteria:\n\n* (1) Patients diagnosed with neuroendocrine\u002Fsmall cell prostate cancer by pathological histology; (2) No clear distant metastasis was found by imaging (in accordance with RECIST criteria); (3) Patients with a history of previous treatment: including neoadjuvant and adjuvant therapy; (4) The samples submitted for examination failed to meet the quality control requirements.\n\n  (5) Patients with combined endocrine, metabolic system diseases or other serious digestive system diseases; (6) Patients with combined chronic hepatitis, cirrhosis, chronic nephritis, renal insufficiency and other diseases; (7) Patients with a history of immunodeficiency, including HIV positive or other acquired or congenital immunodeficiency diseases, or a history of organ transplantation; (8) Patients with a history of other malignant tumors; (9) Patients enrolled in other clinical trials; (10) Patients unable to obtain the clinical information required for the study (e.g., patients lost to follow-up); (11) Other situations that the researchers consider unsuitable for enrollment.",{"count":75,"type":21},50,"OBSERVATIONAL","This study is a prospective, single-center, observational study of patients with newly diagnosed metastatic hormone-sensitive prostate cancer (mHSPC). Minimal residual disease (MRD) detection is used to investigate the actual efficacy responses of mHSPC patients with different gene mutation characteristics to treatment regimens. Factors influencing efficacy are further analyzed to provide a basis for the precise clinical diagnosis and treatment of mHSPC patients.",[79,80,27],"MRD","Prostate Cancer",[82,79,83],"minimal residual disease","PCa","2026-01-08",{"date":86,"type":32},"2026-01-12",{"date":88,"type":21},"2026-01-30",{"date":90,"type":21},"2027-04-30",{"name":92,"class":39},"Anhui Medical University"]