[{"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,4,0,[8,47,71,97],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":29,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":38,"startDateStruct":41,"completionDateStruct":42,"leadSponsor":44,"locationsCount":4},"100650803","phase-3-evaluating-hormone-therapy-to-achieve-optimal-doses-in-metastatic-prostate-cancer-100650803",false,"NCT07751133","Evaluating Hormone Therapy to Achieve Optimal Doses in Metastatic Prostate Cancer","ENHANCE","Inclusion Criteria:\n\n1. Adult males (male sex at birth) aged 18 years or older\n2. Newly histologically or cytologically diagnosed prostate cancer (adenocarcinoma) that is metastatic hormone-sensitive (mHSPC) or metastatic castration resistant prostate cancer (mCRPC), for whom ARPI in combination with androgen deprivation is clinically planned\n3. Prior ADT use for prostate cancer (including bilateral orchidectomy and transcutaneous oestrogen), is permitted provided: (a) ADT has been started less than 12 weeks prior to randomisation in mHSPC, (b) In the adjuvant setting the completion of adjuvant hormonal therapy was \\>12 months prior to randomisation and total duration is capped at 36 months total\n4. ECOG performance status 0-2\n5. Willing and able to give provide written informed consent.\n\nExclusion Criteria:\n\n1. Pathology other than adenocarcinoma consistent with small cell, ductal, sarcomatoid carcinoma of the prostate\n2. Unable or unwilling to receive concurrent ADT alongside an ARPI\n3. Any concurrent or previous malignancy that required active anti-cancer therapy in the previous 2 years of randomisation (other than basal cell or squamous cell carcinoma of the skin or adequately treated non-muscle invasive urothelial bladder carcinoma, Tis, Ta and T1 tumours)\n4. Adults with unmanaged psychological, familial, or sociological conditions precluding them from the ability to provide informed consent or hampering compliance with the study follow-up, including continued drug and alcohol dependence\n5. Patients who have received an investigational drug (either approved or not approved) in any prior clinical study within 30 days or 5 half-lives (whichever is longer) prior to Screening\n6. Patients on triplet therapy (i.e. receiving additional systemic anti-cancer therapy such as chemotherapy, radionuclide\u002Fmolecular radiotherapy, PARPi alongside ADT \\& ARPI); but concomitant radiotherapy is allowed\n7. Hypersensitivity to any of the active components or excipients of the IMPs or NIMPs listed in this protocol\n8. Patients with severe hepatic impairment (Child-Pugh Class C)\n9. Patients with uncontrolled or unstable cardiovascular disease, New York Heart Association congestive cardiac failure class III\u002FIV","MALE","18 Years",{"count":19,"type":20},1500,"ESTIMATED","INTERVENTIONAL",[23],"PHASE3","The goal of this phase 3 clinical trial is to determine the clinical effectiveness and cost effectiveness of using lower doses of Androgen Receptor Pathway Inhibitors (ARPI) to treat patients with prostate cancer that has spread (metastasized). The main questions it aims to answer are:\n\n1. if overall survival for reduced dose ARPI is not worse than standard dose ARPI when treating patients with metastatic prostate cancer, and\n2. that fatigue (extreme exhaustion) and not stopping ARPI permanently (due to adverse effects) are better than average with the reduced dose.\n\nParticipants will:\n\n* Be randomised to take full dose (100%) of ARPI or half dose (50%) of ARPI.\n* Receive standard of care ADT.\n* Be on treatment for approximately 3 years according to standard of care.\n* Have clinic assessments and visits in clinic or remotely, as per their treating hospital's standard routine local practice in line with standard of care. Additional visits are not expected.\n* Complete quality of life questionnaires at week 0 (pre-treatment) and weeks 4, 16, 32, 48 and 64.\n* Keep a diary of their symptoms.\n\nTranslational research samples will be collected as follows:\n\n* Blood samples at week 0 (pre-treatment) and weeks 24, 32, 48 and at disease progression.\n* Urine samples at week 0 (pre-treatment) and week 24 and at disease progression.\n* FFPE Tumour: Routinely collected diagnostic blocks. The duration of follow-up is approximately 3 years after the last patient is recruited (minimum follow-up is 3 years; maximum follow-up is approximately 6 years for the the first patient recruited) and the trial is expected to complete August 2032 (Last Patient Last Visit).",[26,27,28],"Prostate Cancer","mHSPC","mCRPC",[30,31,32,33,34,35],"Prostate cancer","Metastatic","ARPI","ADT","Androgen Receptor Pathway Inhibitor","Androgen Deprivation Therapy","NOT_YET_RECRUITING","2026-08-03",{"date":39,"type":40},"2026-08-07","ACTUAL",{"date":37,"type":20},{"date":43,"type":20},"2033-08-01",{"name":45,"class":46},"University College, London","OTHER",{"id":48,"slug":49,"hasResults":11,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":53,"eligibilityCriteria":54,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":55,"targetDuration":4,"studyType":21,"phases":57,"briefSummary":59,"conditions":60,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":61,"lastUpdatePostDateStruct":62,"startDateStruct":64,"completionDateStruct":66,"leadSponsor":68,"locationsCount":70},"100631645","phase-2-evaluation-of-the-efficacy-and-safety-of-darolutamide--adt-combined-with-low-dose-docetaxel-in-mhspc-100631645","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",{"count":56,"type":20},109,[58],"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],"2026-03-25",{"date":63,"type":40},"2026-03-31",{"date":65,"type":20},"2026-04",{"date":67,"type":20},"2028-12",{"name":69,"class":46},"Yonghong Li",2,{"id":72,"slug":73,"hasResults":11,"nctId":74,"briefTitle":75,"officialTitle":76,"acronym":4,"eligibilityCriteria":77,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":78,"enrollmentInfo":79,"targetDuration":4,"studyType":21,"phases":81,"briefSummary":83,"conditions":84,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":87,"lastUpdatePostDateStruct":88,"startDateStruct":90,"completionDateStruct":92,"leadSponsor":94,"locationsCount":96},"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":80,"type":20},40,[82],"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.",[27,85,86],"mHNPC","Prostate Cancer Adenocarcinoma","2026-02-03",{"date":89,"type":40},"2026-02-05",{"date":91,"type":20},"2026-02",{"date":93,"type":20},"2027-06",{"name":95,"class":46},"Shanghai Changzheng Hospital",1,{"id":98,"slug":99,"hasResults":11,"nctId":100,"briefTitle":101,"officialTitle":102,"acronym":4,"eligibilityCriteria":103,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":78,"enrollmentInfo":104,"targetDuration":4,"studyType":106,"phases":4,"briefSummary":107,"conditions":108,"keywords":110,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":113,"lastUpdatePostDateStruct":114,"startDateStruct":116,"completionDateStruct":118,"leadSponsor":120,"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":105,"type":20},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.",[109,26,27],"MRD",[111,109,112],"minimal residual disease","PCa","2026-01-08",{"date":115,"type":40},"2026-01-12",{"date":117,"type":20},"2026-01-30",{"date":119,"type":20},"2027-04-30",{"name":121,"class":46},"Anhui Medical University"]