[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Yung NA\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":72},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,43],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":28,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":5},"100616809","phase-2-dapagliflozin-combined-with-next-generation-hormonal-agent-nha-versus-single-nha-in-participants-with-metastatic-castrate-resistant-prostate-cancer-100616809",false,"NCT07310433","Dapagliflozin Combined With Next-generation Hormonal Agent (NHA) Versus Single NHA in Participants With Metastatic Castrate-resistant Prostate Cancer","Dapagliflozin Combined With Next-generation Hormonal Agent (NHA) Versus Single NHA in Participants With Metastatic Castrate-resistant Prostate Cancer: a Phase 2, Multicenter, Open-label, Randomized Controlled Trial","Inclusion Criteria:\n\n* Age of 18 years and above\n* Histologically or cytologically confirmed diagnosis of prostatic adenocarcinoma without neuroendocrine\u002F small cell histology;\n* PCa progression while receiving ADT (or post bilateral orchiectomy) within 6 months before screening: two consecutive rising PSA levels, radiographic soft tissue or bone progression;\n* Current evidence of metastatic disease by radiological scan;\n* Decided to receive any of the NHA (including Abiraterone Acetate, Enzalutamide, Apalutamide or Darolutamide) under standard of care setting, or started NHA for no more than 28 days at the time of treatment period start;\n* Ongoing androgen deprivation with serum testosterone \\\u003C50 ng\u002FdL (\\\u003C1.7 nM);\n* Naïve of taxane-based chemotherapy regimens;\n* Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1;\n* Normal hematologic and organ function as defined below: (a) leukocytes ≥ 3,000\u002FmcL; (b) absolute neutrophil count ≥ 1,500\u002FmcL; (c) platelets ≥ 100,000\u002FmcL; (d) total bilirubin ≤ 1.5 x institutional upper limit of normal (IULN); (e) AST(SGOT)\u002FALT(SGPT) ≤ 3.0 x IULN; (f) estimated glomerular filtration rate eGFR ≥ 30 mL\u002Fmin\u002F1.73m2;\n* Ability to understand and willingness to sign an IRB-approved written informed consent document.\n\nExclusion Criteria:\n\n* Current or previous treatment with SGLT2 inhibitors or thiazolidinedione;\n* Presence of type 1 diabetes mellitus, insulin-requiring diabetes mellitus or poorly controlled diabetes mellitus (i.e., HbA1c \\> 10%, unless approved by endocrinologist);\n* Presence of malignancies other than prostate cancer within two years prior to study enrollment;\n* Disease progressed during or after treatment with one NHA;\n* A history of allergic reactions attributed to compounds of similar chemical or biologic composition to dapagliflozin;\n* Clinically significant abnormal serum potassium or sodium level;\n* Presence of uncontrolled comorbidities including but not limited to ongoing or active infection (e.g., HIV, HBV, HCV and tuberculosis), symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, peripheral arterial disease, ketoacidosis, severe kidney disease, symptomatic hypotension, and chronic\u002Ffrequent urinary tract infections or yeast infections;\n* Participation in another clinical trial with therapeutic intent within 28 days prior to enrollment;\n* Inability to swallow capsules\u002Ftablets\n* Any medical conditions that might deem unsafe or contraindicated for inclusion in the clinical trial, per investigator's discretion","MALE","18 Years",{"count":19,"type":20},60,"ESTIMATED","INTERVENTIONAL",[23],"PHASE2","Dapagliflozin is a well-established medication being marketed and used for treatment Type 2 diabetes mellitus (T2DM). In retrospective cohort studies done by our team, we found that metastatic prostate cancer patients who received Dapagliflozin together with standard anti-cancer treatment, androgen deprivation therapy (ADT) combined with novel hormonal agent (NHA), had better tumor control than those having ADT and NHA.",[26,27],"Prostate Cancer","Metastatic Prostate Cancer",[29,30],"prostate cancer","sglt2","NOT_YET_RECRUITING","2025-12-15",{"date":34,"type":35},"2025-12-30","ACTUAL",{"date":37,"type":20},"2026-06-01",{"date":39,"type":20},"2030-10-30",{"name":41,"class":42},"Yung NA","OTHER",{"id":44,"slug":45,"hasResults":11,"nctId":46,"briefTitle":47,"officialTitle":48,"acronym":4,"eligibilityCriteria":49,"healthyVolunteers":11,"sex":50,"minAge":17,"maxAge":51,"enrollmentInfo":52,"targetDuration":4,"studyType":21,"phases":54,"briefSummary":55,"conditions":56,"keywords":59,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":64,"lastUpdatePostDateStruct":65,"startDateStruct":67,"completionDateStruct":69,"leadSponsor":70,"locationsCount":71},"100535837","phase-2-surveillance-of-the-genetic-signature-in-circulating-tumor-dna-for-guiding-adjuvant-chemotherapy-in-urothelial-carcinoma-100535837","NCT06257017","Surveillance of the Genetic Signature in Circulating Tumor DNA for Guiding Adjuvant Chemotherapy in Urothelial Carcinoma","Surveillance of the Genetic Signature in Circulating Tumor DNA for Guiding Adjuvant Chemotherapy in Urothelial Carcinoma: A Pilot Randomized Controlled Trial","Inclusion Criteria:\n\n1. aged 18-70 years old;\n2. a score of ≤1 for the Eastern Cooperative Oncology Group (ECOG) Performance Status;\n3. receiving radical cystectomy (with lymph node dissection) or nephroureterectomy;\n4. histologically confirmed (surgical specimen) muscle invasive urothelial carcinoma, and the major histological type should be transitional cell carcinoma;\n5. Classification of tumour, node and metastasis (TNM): pT2-4a N0-2M0;\n6. absence of microscopic (i.e., positive margin) or gross residual of the tumor (R0 resection) and absence of metastasis, confirmed by a negative CT or MRI scan of pelvis, abdomen and chest within 4 weeks prior to enrolment;\n7. adequate hematologic and end-organ function, defined by the following laboratory results obtained within 28 days prior to the first study treatment:\n\n   * ANC≥1500 cells\u002FμL (without granulocyte colony-stimulating factor support within 2 weeks prior to Cycle 1, Day 1)\n   * WBC counts \\> 2500 cells\u002FμL\n   * Lymphocyte count ≥ 300 cells\u002FμL\n   * Platelet count ≥ 100,000 cells\u002FμL (without transfusion within 2 weeks prior to Cycle 1, Day 1)\n   * Hemoglobin ≥ 9.0 g\u002FdL\n   * AST, ALT, and alkaline phosphatase ≤ 2.5 × the upper limit of normal (ULN),\n   * PTT ≤ 1.5 × ULN\n   * PT ≤ 1.5 × ULN or INR \\\u003C 1.7\n   * Calculated creatinine clearance ≥ 30 mL\u002Fmin (Cockcroft-Gault formula)\n8. able to understand and provide written informed consent, and agree to receive the treatment arrangement and study procedures stated in the informed consent\n\nExclusion Criteria:\n\n1. receiving any approved anti-cancer treatment within 3 weeks prior to study enrolment;\n2. participation in another clinical trial with therapeutic intent within 28 days prior to enrolment;\n3. suffering from malignancies other than urothelial carcinoma within 5 years prior to study enrolment;\n4. conditions that contraindicate chemotherapy, such as renal impairment with creatinine clearance rate (CCr) \\\u003C50 mL\u002Fmin, hearing impairment, and inadequate marrow function;\n5. anaphylactic or hypersensitivity reactions or other contraindication to cisplatin and gemcitabine;\n6. active or uncontrolled infections, including human immunodeficiency virus (HIV), hepatitis B virus (HBV), hepatitis C virus (HCV), or tuberculosis;\n7. pregnancy or breastfeeding.","ALL","70 Years",{"count":53,"type":20},20,[23],"Urothelial carcinomas are one of the most commonly diagnosed cancers worldwide. Postoperative patients carry a poor prognosis with an estimated five-year disease-specific survival rate of 50%. To improve overall survival and reduce the recurrent risk, chemotherapy is recommended as a standard of care. However, currently in Hong Kong, neoadjuvant (preoperational) chemotherapy and adjuvant (postoperative) chemotherapy are not commonly or regularly provided due to the concern of the potential harm from both physicians and patients. Recently, genetic signature from circulating tumor DNA (ctDNA) is emerging as a pivotal biomarker for detecting caner in early stage and molecular residual disease (MRD). With strengths of non-invasive and superior sensitivity, ctDNA is hopefully to serve as a cancer-agnostic surrogate analyte for risk stratification of tumor recurrence, thereby guiding individually tailored treatment. Therefore, this study is proposed to exploratively assess the benefit of ctDNA-guided approach for postoperative adjuvant therapy.",[57,58],"Muscle Invasive Bladder Urothelial Carcinoma","Muscle-Invasive Bladder Carcinoma",[60,61,62],"circulating tumor DNA","ctDNA","molecular residual disease","RECRUITING","2025-04-01",{"date":66,"type":35},"2025-04-04",{"date":68,"type":35},"2024-02-02",{"date":34,"type":20},{"name":41,"class":42},1,""]