[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"metastatic-hormone-sensitive-prostate-cance\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:metastatic-hormone-sensitive-prostate-cance":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,46],{"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":28,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":45},"100648111","phase-2-radium-223-for-high-volume-metastatic-hormone-sensitive-prostate-cancer-100648111",false,"NCT07717099","Radium-223 for High-Volume Metastatic Hormone Sensitive Prostate Cancer","Quantitative Unified Assessment of Novel Triplet Therapy and Unconventional Maintenance With Radium-223 for High-Volume Metastatic Hormone Sensitive Prostate Cancer: A Phase II Pilot Trial","GUARD-QUANTUM","INCLUSION CRITERIA\n\nSubjects must fulfill all of the following inclusion criteria to be eligible for enrollment to the study:\n\n1. Patients must be fully informed about the study and sign the informed consent form (ICF) before any study specific assessment.\n2. Patients ≥18 years old.\n3. ECOG performance status of 0 to 2 and Charlson score ≤ 3 prior to study entry, after docetaxel.\n4. Patients with histologically or cytologically confirmed diagnosis of prostate adenocarcinoma.\n5. Patients should have received triplet therapy with ADT (luteinizing hormone releasing hormone analogue (LHRHA) for continuous treatment or previous bilateral orchidectomy), docetaxel and darolutamide as first-line therapy for mHSPC. The following conditions apply:\n\n   1. Received ≥ 4 cycles of docetaxel.\n   2. Treatment with docetaxel should be finished ≤ 12 weeks before the first planned dose of Ra223.\n   3. Having no progression of the disease after triplet therapy completion and before inclusion.\n\n   Note: patients with prior therapies for locoregional disease are acceptable\n6. Patients should have recovered from any prior toxicity from ADT, darolutamide or docetaxel to CTCAE grade 1 or baseline levels.\n7. Presence of at least 4 bone metastasis on the screening bone scan, with or without lymph node and\u002For visceral metastases.\n8. Asymptomatic or mildly symptomatic (defined as short form question #3 in Brief Pain Inventory worst pain must be \\\u003C 4).\n9. Patients should be willing to initiate or continue bisphosphonates \u002Fdenosumab, calcium and vitamin D supplements (Section 7.4.4) prior to the first dose of Ra223.\n\n   Note: Patients must start treatment with a bone protecting agent (at doses used to reduce the incidence of skeletal related events) before the time of signing the ICF. A minimum of two doses is recommended before the first administration of Ra223. The first administration of Ra223 should be scheduled at least 6 weeks after the first administration of the bone protecting agent.\n10. T-score ≥ -2.5 on a DXA scan done in the past 12 months. A DXA scan performed during the screening period will be encouraged but not mandated.\n11. Adequate organ and bone marrow function as follows (subject must not have received any growth factor within 4 weeks or a blood transfusion within 7 days of the hematology laboratory):\n\n    1. Absolute neutrophil count (ANC) ≥ 1.5 x109\u002FL;\n    2. Platelets ≥ 100 x109\u002FL;\n    3. Hemoglobin ≥ 9.0 g\u002Fdl;\n    4. Total bilirubin level ≤ 1.5 x institutional upper limit of normal (ULN), except for patients with Gilbert's disease ≤ 5.0 x ULN;\n    5. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 x ULN;\n    6. Creatinine ≤ 1.5 x ULN;\n    7. CrCl \\\u003C 30 mL\u002Fmin;\n    8. Albumin \\> 25 g\u002FL.\n12. Participants who have pregnant partners must use a condom and those with partners of childbearing potential must use a condom and another adequate birth control measure if engaging in sexual activities during the study treatment period and for at least 1 week after last dose of darolutamide and 6 months after the last dose of Ra223. A highly effective method of birth control is defined as those which result in low failure rate (i.e., less than 1% per year) when used consistently and correctly.\n\nEXCLUSION CRITERIA:\n\nSubjects with any of the following could not enroll in this study:\n\n1. Presence of tumor lesion in central nervous system through radiologically confirmed diagnosis.\n2. Prior history of malignancies other than prostate adenocarcinoma (except patients with basal cell, squamous cell carcinoma of the skin, in-situ carcinoma or low-grade superficial bladder cancer, or the patient has been free of malignancy for a period of 3 years prior to inclusion).\n3. Patients experiencing progression during previous ADT or meeting criteria for castration resistant prostate cancer (CRPC).\n\n   Note: Prior ADT is allowed.\n4. External irradiation, brachytherapy, or local treatment (including radiofrequency ablation, cryotherapy, high intensity focused ultrasound, etc.) within 4 weeks prior to the first dose of study treatment.\n5. Received prior chemotherapy for prostate cancer other than as part of first-line triplet therapy for mHSPC.\n6. Major surgery within 4 weeks prior to treatment.\n7. Prior hemibody external radiotherapy.\n8. Corticosteroids are allowed only at a dose ≤ 10 mg of prednisone (or equivalent) no matter the indication.\n9. Receiving abiraterone treatment as part of the first-line triplet therapy for mHSPC.\n\n   Note: An increased risk of death and fractures was observed in a clinical study in which Ra223 was added to abiraterone acetate and prednisone\u002Fprednisolone in patients with asymptomatic or mildly symptomatic CRPC and this is the rationale to not include patients with this combination.\n10. Plan to receive any other antitumor therapies during this trial.\n11. Treatment with an investigational drug within the previous 4 weeks, or planned during the treatment period.\n12. Any other serious illness or medical condition such as, but not limited to:\n\n    1. Any uncontrolled infection ≥ Grade 2 according to NCI-CTCAE v6.0;\n    2. Gastrointestinal disorder affecting absorption (e.g., gastrectomy or active peptic ulcer disease);\n    3. Crohn's disease or ulcerative colitis;\n    4. Osteonecrosis of the jaw;\n    5. Non-malignant bone disease with an osteoblastic activity;\n    6. Bone marrow dysplasia;\n    7. Fecal incontinence;\n    8. Life-threatening illness unrelated to cancer.\n13. Significant cardiovascular disease including:\n\n    1. Uncontrolled angina within 3 months prior to screening;\n    2. Congestive heart failure New York Heart Association (NYHA) class III or IV, or patients with history of congestive heart failure NYHA class III or IV in the past, unless a screening echocardiogram or multi-gated acquisition scan (MUGA) performed within 3 months results in a left ventricular ejection fraction that is ≥ 45%. Of note, MUGA scans at baseline will not be mandated.\n    3. History of clinically significant ventricular arrhythmias (e.g., ventricular tachycardia, ventricular fibrillation, torsades de pointes);\n    4. History of Mobitz II second degree or third degree heart block without a permanent pacemaker in place;\n    5. Uncontrolled hypertension as indicated by a resting systolic blood pressure \\> 160 millimeters of mercury (mm Hg) or diastolic blood pressure \\> 100 mm Hg at screening; Note: Initiation or adjustment of antihypertensive medication(s) is permitted prior to inclusion. Blood pressure must be re-assessed on two occasions that are separated by a minimum of 1 hour. The mean SBP \u002F DBP values from each blood pressure assessment must be ≤ 160\u002F100 mm Hg in order for a patient to be eligible for the study.\n14. Known hypersensitivity to any of the study drugs, study drug classes, or excipients in the formulation of the study drugs. No known hypersensitivity to Ra223 (refer to summary of product characteristics \\[SmPC\\]).\n15. Contraindication to both CT and MRI contrast agents.\n16. Contraindications for the use of bisphosphonates or denosumab as per physician judgment.\n17. Involvement in another therapeutic trial involving an experimental drug.\n18. Drug or alcohol abuse.\n19. Any medical condition that in the opinion of the investigator will negatively affect patients' clinical status when participating in this trial.","MALE","18 Years",{"count":20,"type":21},50,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","GUARD-QUANTUM is a prospective, phase II, single-arm, non-randomized, non-blinded, investigator-initiated study. The rationale behind studying this combination lies in the potential additive or synergistic benefits that may arise from concurrently targeting androgen receptor signaling pathways and bone metastases.",[27],"Metastatic Hormone-Sensitive Prostate Cance",[29,30,31,32],"Ra-223","Prostate cancer","hormone-sensitive","Androgen Pathway Modulation-Sensitive","NOT_YET_RECRUITING","2026-07-16",{"date":36,"type":37},"2026-07-21","ACTUAL",{"date":39,"type":21},"2026-09",{"date":41,"type":21},"2029-12",{"name":43,"class":44},"Alianza multidisciplinar para la investigación de los tumores genitourinarios -GUARD","OTHER",12,{"id":47,"slug":48,"hasResults":11,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":4,"eligibilityCriteria":52,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":53,"enrollmentInfo":54,"targetDuration":4,"studyType":56,"phases":4,"briefSummary":57,"conditions":58,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":59,"lastUpdatePostDateStruct":60,"startDateStruct":62,"completionDateStruct":64,"leadSponsor":66,"locationsCount":4},"100604853","a-novel-insight-into-crpc-progression-and-immune-evidence-from-single-cell-spatial-transcriptome-multi-omics-100604853","NCT07154914","A Novel Insight Into CRPC Progression and Immune: Evidence From Single-cell Spatial Transcriptome Multi-omics","Mapping Prostate Cancer Evolution and Therapy Resistance With Single-Cell Technologies","Inclusion Criteria:\n\n1. Male patients, age \\>18 and \\\u003C85 years.\n2. Histologically confirmed prostate adenocarcinoma, ductal adenocarcinoma, or intraductal carcinoma.\n3. Evidence of distant metastases by imaging (according to RECIST criteria).\n4. No prior systemic therapy for prostate cancer (no ADT or other systemic treatments).\n5. ECOG performance status 0-2 and estimated life expectancy \\>6 months.\n6. Adequate organ function as indicated by:\n\n   * Hemoglobin ≥ 90 g\u002FL\n\n     * ANC ≥ 1.5 × 10\\^9\u002FL\n\n       * Platelet count ≥ 75 × 10\\^9\u002FL\n\n         * WBC ≥ 3 × 10\\^9\u002FL ⑤ Total bilirubin ≤ ULN ⑥ ALT\u002FAST ≤ 2.5 × ULN ⑦ Creatinine clearance ≥ 30 mL\u002Fmin (Cockcroft-Gault formula)\n\n           * INR ≤ 1.5 or PT \\\u003C 4 sec above ULN\n7. Ability to provide written informed consent.\n\nExclusion Criteria:\n\n1. Histological diagnosis of neuroendocrine or small-cell prostate cancer.\n2. No evidence of distant metastases on imaging.\n3. Prior systemic therapy for prostate cancer (neoadjuvant, adjuvant, or systemic).\n4. Severe endocrine, metabolic, gastrointestinal, hepatic, or renal disease (including chronic hepatitis, cirrhosis, chronic nephritis, or renal failure).\n5. History of immunodeficiency, including HIV positivity, congenital immunodeficiency, or organ transplantation.\n6. History of other malignancies (except non-melanoma skin cancer).\n7. Concurrent participation in another clinical trial.\n8. Inability to provide clinical information or anticipated loss to follow-up.\n9. Any condition deemed unsuitable for study participation by the investigator.","85 Years",{"count":55,"type":21},396,"OBSERVATIONAL","This study will follow patients with metastatic hormone-sensitive prostate cancer (mHSPC) who receive androgen deprivation therapy (ADT) combined with different treatments. Prostate cancer is a common cancer in men, and many patients in China are diagnosed at an advanced stage. While ADT alone has been the standard treatment, most patients eventually progress to castration-resistant disease.\n\nNew medicines such as abiraterone, enzalutamide, apalutamide, darolutamide, and chemotherapy like docetaxel have shown survival benefits when added to ADT. This study aims to observe how different ADT-based combinations work in real-world practice and whether genetic differences affect outcomes.\n\nAbout 396 patients will be enrolled and followed until disease progression or death. The results will help identify which treatments are most effective and guide more personalized care for men with advanced prostate cancer.",[27],"2025-08-27",{"date":61,"type":37},"2025-09-04",{"date":63,"type":21},"2025-09-01",{"date":65,"type":21},"2026-09-01",{"name":67,"class":44},"Anhui Medical University"]