[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"metastatic-hormone-sensitive-prostate-cancer\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:metastatic-hormone-sensitive-prostate-cancer":25},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,10,0,[8,39,70,104,127,149,176,197,219,241],{"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":4,"briefSummary":22,"conditions":23,"keywords":4,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":27,"lastUpdatePostDateStruct":28,"startDateStruct":31,"completionDateStruct":33,"leadSponsor":35,"locationsCount":38},"100541765","an-observational-study-to-learn-more-about-the-safety-of-darolutamide-in-men-with-prostate-cancer-in-korea-100541765",false,"NCT06334120","An Observational Study to Learn More About the Safety of Darolutamide in Men With Prostate Cancer in Korea","Post-marketing Surveillance Study for Approved Darolutamide Use in Korean Patients","Inclusion Criteria:\n\n* Male aged ≥19 years\n* Patients with high risk nmCPRC\n\n  * Castrate level of serum testosterone (\\\u003C 1.7 nmol\u002Fl \\[50 ng\u002FdL\\])\n  * PSA doubling time \\\u003C 10 months\n* Patients with mHSPC\n\n  * histologically or cytologically confirmed prostate cancer, and metastases detected on bone scanning, contrast-enhanced computed tomography (CT), or magnetic resonance imaging (MRI).\n  * be candidates for androgen-deprivation therapy with\u002Fwithout docetaxel.\n* Patients for whom the decision to initiate treatment with Darolutamide as a first time was made as per investigator's routine treatment practice\n* Written informed consent from subject or legal representative; assent from subject when appropriate\n\nExclusion Criteria:\n\n* Patients participating in an investigational program with interventions outside of routine clinical practice\n* Participants with contraindication according to the locally approved prescribing information","MALE","19 Years",{"count":19,"type":20},600,"ESTIMATED","OBSERVATIONAL","This is an observational study in which participants receive a treatment which is already available for doctors to prescribe for non-metastatic castration-resistant prostate cancer (nmCRPC) or metastatic hormone-sensitive prostate cancer (mHSPC). nmCRPC is a prostate cancer that has not yet spread to other parts of the body and does not respond to lowering testosterone in the body. mHSPC is a prostate cancer that has spread to other parts of the body and can be treated by lowering testosterone levels.\n\nThis study looks at the safety of the study drug, darolutamide, in Korean patients with nmCRPC or mHSPC. Darolutamide is currently available for doctors to prescribe to men with nmCRPC or mHSPC. It works by attaching to the special molecules called androgen receptors (AR) within prostate cells and blocks hormones called androgens from attaching to AR, which helps delay cancer growth.\n\nTo learn more about the safety of Darolutamide, the researchers will study whether the participants have adverse events. An adverse event is any medical problem that a participant has during a study. Doctors keep track of all adverse events that happen in studies, even if they do not think the adverse events might be related to the study treatments. The researchers will also learn more about how well darolutamide is working in these participants.\n\nDuring this study, the researchers will collect information from the medical records of patients who have been prescribed darolutamide by their doctors.\n\nEach participant will be in this study for 1 year. The whole study will last about 6 years. During this time, the participants will visit their doctor every 2 to 4 months as part of their usual care. At these visits, the doctors will do scans to check the patients' cancer and take blood samples. The patients will answer questions about any medications they are taking and whether they have any adverse events.",[24,25],"Non-metastatic Castration-resistant Prostate Cancer","Metastatic Hormone-sensitive Prostate Cancer","RECRUITING","2026-06-23",{"date":29,"type":30},"2026-06-24","ACTUAL",{"date":32,"type":30},"2024-09-25",{"date":34,"type":20},"2028-06-30",{"name":36,"class":37},"Bayer","INDUSTRY",1,{"id":40,"slug":41,"hasResults":11,"nctId":42,"briefTitle":43,"officialTitle":43,"acronym":44,"eligibilityCriteria":45,"healthyVolunteers":11,"sex":16,"minAge":46,"maxAge":4,"enrollmentInfo":47,"targetDuration":4,"studyType":49,"phases":50,"briefSummary":52,"conditions":53,"keywords":54,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":59,"lastUpdatePostDateStruct":60,"startDateStruct":62,"completionDateStruct":64,"leadSponsor":66,"locationsCount":69},"100618549","phase-3-phase-iii-randomized-international-open-label-clinical-trial-of-treatment-intensification-with-docetaxel-plus-apalutamide-in-patients-with-metastatic-hormone-sensitive-prostate-cancer-who-did-not-achieve-a-deep-psa-response-after-initial-treatment-with-apalutamide-reinforce-trial-100618549","NCT07333066","Phase III Randomized International Open Label Clinical Trial of Treatment Intensification With Docetaxel Plus Apalutamide in Patients With Metastatic Hormone-sensitive Prostate Cancer Who Did Not Achieve a Deep PSA Response After Initial Treatment With Apalutamide: REINFORCE Trial.","REINFORCE","Inclusion Criteria:\n\n1. Written informed consent. Each patient must sign an informed consent form (ICF) indicating that he understands the purpose of and procedures, required for the study, and is willing to participate in the study.\n2. Patient must be a man ≥18 years of age.\n3. Histologically or cytologically confirmed adenocarcinoma of prostate.\n4. Metastatic hormone-sensitive prostate cancer.\n5. PSA \\>5 ng\u002Fml at diagnosis of metastatic disease.\n6. Patients eligible to continue treatment with apalutamide and ADT and without contra-indication to receive docetaxel.\n7. Patients with at least 24 weeks and no more than 30 weeks of apalutamide.\n8. Patients with a maximum of 12 weeks ADT before apalutamide initiation.\n9. Lack of achievement of deep PSA response after 24 weeks and no more than 30 weeks of apalutamide. Deep PSA response is defined as PSA ≤ 0.2 ng\u002Fml or PSA response ≥ 90% in combination with a PSA ≤4 ng\u002Fml. Therefore, a non-deep PSA response is defined as PSA \\> 0.2 ng\u002Fml in combination with a PSA response \\\u003C 90%, or a PSA response ≥90% in combination with a PSA \\> 4 ng\u002Fml.\n10. Patients who have not progressed to apalutamide.\n11. Patients that are tolerating adequately apalutamide 240 mg daily and with no toxicity higher than G1 at inclusion.\n12. Be able to swallow whole apalutamide film-coated tablets.\n13. Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1.\n14. Clinical laboratory values at screening:\n\n    1. hemoglobin ≥10.0 g\u002FdL,\n    2. absolute neutrophil count ≥1.5 × 10\\*9\u002FL,\n    3. platelet count ≥100 × 109\u002FL, The patient must not have received any growth factor within 4 weeks or a blood transfusion within 7 days of the hematology laboratory sample obtained at screening\n    4. serum alanine aminotransferase and\u002For aspartate transaminase ≤1.5 × the upper limit of normal (ULN),\n    5. total bilirubin ≤ ULN,\n    6. creatinine ≤2.0 × ULN\n15. Sexually active men must agree to use an external condom as an effective barrier method and refrain from sperm donation, and their female partners of childbearing potential must practice a highly effective method of contraception during and for 3 months after treatment with apalutamide and for 6 months after treatment with docetaxel.\n\nExclusion Criteria:\n\n1. Presence of neuroendocrine histology.\n2. Apalutamide treatment started more than 30 weeks before inclusion.\n3. Progression disease by any means, including radiographic, clinical or serological at inclusion.\n4. Patient who achieves deep PSA response on apalutamide treatment before randomization.\n5. Previous androgen-pathway receptor inhibitors, including enzalutamide, darolutamide, abiraterone or other ARPI. Previous treatment with first generation antiandrogens (i.e. bicalutamide) is allowed.\n6. Chemotherapy or immunotherapy for prostate cancer before randomization.\n7. Treatment with radiotherapy (external-beam radiation therapy, brachytherapy, or radiopharmaceuticals) within 2 weeks before randomization.\n8. Known hypersensitivity to any of the study drugs, study drug classes, or excipients in the formulation of the study drugs.\n9. Contraindication to both computed tomography and magnetic resonance imaging contrast agent.\n10. Prolonged QT interval defined as QTcF ≥ 480 ms at screening, based on the mean of triplicate 12-lead ECGs performed after at least 5 minutes of rest. Patients with congenital long QT syndrome will also be excluded.\n11. Any of the following within 6 months before randomization:\n\n    1. stroke,\n    2. myocardial infarction,\n    3. severe or unstable angina pectoris,\n    4. uncontrolled arrhythmia,\n    5. coronary or peripheral artery bypass graft, or\n    6. congestive heart failure (New York Heart Association class III or IV)\n12. Peripheral neuropathy ≥ grade 2.\n13. Uncontrolled hypertension, indicated by resting systolic blood pressure ≥160 mmHg or diastolic blood pressure ≥100 mmHg despite medical management.\n14. Prior malignancy, except for adequately treated basal-cell or squamous-cell carcinoma of the skin or superficial bladder cancer that had not spread behind the connective-tissue layer (i.e., stage pTis, pTa, or pT1) or any cancer for which treatment had been completed ≥5 years before randomization and from which the patient was disease-free.\n15. A gastrointestinal disorder or procedure that was expected to interfere significantly with absorption of study drug.\n16. Active viral hepatitis, known human immunodeficiency virus infection with detectable viral load, or chronic liver disease requiring treatment.\n17. Previous (within 28 days before the start of study drug or 5 half-lives of the investigational treatment of the previous study, whichever was longer) or concomitant participation in another clinical study with investigational medicinal products.\n18. Any other serious or unstable illness or medical, social, or psychological condition that could jeopardize the safety of the patient and\u002For their compliance with study procedures or might interfere with their participation in the study or evaluation of the study results.","18 Years",{"count":48,"type":20},320,"INTERVENTIONAL",[51],"PHASE3","This is a phase III, randomized, open-label, multi-center study to assess the efficacy of treatment intensification with docetaxel plus apalutamide and ADT, assessed by event-free survival, in patients with mHSPC who do not achieve deep PSA response (≤0,2 ng\u002Fml or PSA90 response in combination with a PSA ≤ 4 ng\u002Fml) after initial treatment with apalutamide and ADT. A non-deep PSA response is defined as PSA \\> 0.2 ng\u002Fml in combination with a PSA response \\\u003C 90%, or a PSA response ≥90% in combination with a PSA \\> 4 ng\u002Fml.",[25],[55,56,57,58],"Prostate Cancer","Apalutamide","Hormone-sensitive prostate cancer","Deep PSA response","2026-06-15",{"date":61,"type":30},"2026-06-17",{"date":63,"type":30},"2026-06-05",{"date":65,"type":20},"2030-03-31",{"name":67,"class":68},"Alianza multidisciplinar para la investigación de los tumores genitourinarios -GUARD","OTHER",56,{"id":71,"slug":72,"hasResults":11,"nctId":73,"briefTitle":74,"officialTitle":75,"acronym":4,"eligibilityCriteria":76,"healthyVolunteers":11,"sex":16,"minAge":46,"maxAge":4,"enrollmentInfo":77,"targetDuration":4,"studyType":49,"phases":79,"briefSummary":81,"conditions":82,"keywords":83,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":94,"lastUpdatePostDateStruct":95,"startDateStruct":97,"completionDateStruct":99,"leadSponsor":101,"locationsCount":103},"100592294","phase-2-an-open-label-study-of-jsb462-luxdegalutamide-in-combination-with-abiraterone-in-adult-male-patients-with-metastatic-hormone-sensitive-prostate-cancer-mhspc-100592294","NCT06991556","An Open-label Study of JSB462 (Luxdegalutamide) in Combination With Abiraterone in Adult Male Patients With Metastatic Hormone-sensitive Prostate Cancer (mHSPC)","A Phase II, Randomized, Open-label, Multi-center Study of JSB462 (Luxdegalutamide) in Combination With Abiraterone in Adult Male Patients With Metastatic Hormone-sensitive Prostate Cancer (mHSPC)","Key Inclusion Criteria:\n\n* An Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) ≤2\n* Histologically confirmed adenocarcinoma of the prostate. Participants with mixed histology (neuroendocrine) are not eligible\n* High-volume mHSPC, defined by the presence of ≥1 metastatic visceral non-nodal lesion and\u002For ≥4 metastatic bone lesions (with at least one lesion outside the vertebral column and\u002For pelvis) in imaging exams (CT\u002FMRI or bone scan) according to local radiology assessment by the investigator obtained ≤28 days prior to randomization\n* Participants must have a castrate level of serum\u002Fplasma testosterone (\\\u003C50 ng\u002FdL or \\\u003C1.7 nmol\u002FL). Ongoing ADT (as defined by prior orchiectomy and\u002For ongoing GnRH analog\u002Fantagonist) for ≤90 days is allowed prior to randomization, provided that PSA zero (PSA level \\\u003C0.2 ng\u002Fml according to local laboratory as assessed by the investigator) is not achieved prior to randomization.\n\nKey Exclusion Criteria:\n\n* Prior exposure to a second generation ARPI (such as enzalutamide\u002Fdarolutamide\u002Fapalutamide and\u002For abiraterone) for the treatment of advanced\u002Fmetastatic disease is not allowed. Prior exposure to ARPI, to taxane chemotherapy (up to 6 cycles) or to RLT in the context of (neo)adjuvant treatment for localized prostate cancer is allowed, if the last dose of this treatment was administered \\>12 months from randomization. Prior use of a first generation ARPI (such as bicalutamide) in the context of ADT initiation with a GnRH analog is allowed, provided the first generation ARPI was administered for ≤14 days and last dose was administered ≥7 days from randomization.\n* Participants with biochemical recurrence only or those without evidence of metastatic disease by radiological imaging (CT\u002FMRI or bone scan) are not eligible\n\nOther inclusion\u002Fexclusion criteria may apply.",{"count":78,"type":20},150,[80],"PHASE2","This Phase II study aims to evaluate efficacy and safety of the combination of JSB462 (also known as luxdegalutamide) at 100 mg and 300 mg once a day (QD) doses + abiraterone compared with an androgen receptor pathway inhibitor (ARPI, abiraterone or enzalutamide) in participants with metastatic Hormone Sensitive Prostate Cancer (mHSPC) and to select the recommended dose of the combination for phase III. Towards that end, the totality of the efficacy, safety, tolerability and PK data from participants randomized in the study will be evaluated",[25],[84,85,86,87,88,89,90,91,92,93],"Interventional","clinical trial","open-label","JSB462","luxdegalutamide","efficacy","safety","tolerability","abiraterone","metastatic hormone-sensitive prostate cancer","2026-06-09",{"date":96,"type":30},"2026-06-10",{"date":98,"type":30},"2025-07-07",{"date":100,"type":20},"2035-10-19",{"name":102,"class":37},"Novartis Pharmaceuticals",67,{"id":105,"slug":106,"hasResults":11,"nctId":107,"briefTitle":108,"officialTitle":109,"acronym":110,"eligibilityCriteria":111,"healthyVolunteers":11,"sex":16,"minAge":46,"maxAge":4,"enrollmentInfo":112,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":114,"conditions":115,"keywords":117,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":119,"lastUpdatePostDateStruct":120,"startDateStruct":121,"completionDateStruct":123,"leadSponsor":125,"locationsCount":38},"100627620","a-study-to-assess-adherence-to-apalutamide-in-metastatic-hormone-sensitive-prostate-cancer-participants-in-france-100627620","NCT07451002","A Study to Assess Adherence to Apalutamide in Metastatic Hormone-Sensitive Prostate Cancer Participants in France","An OBServational Prospective Study in France: Adherence to APAlutamide in Metastatic Hormone-Sensitive Prostate Cancer (mHSPC) Patients in France","OBSAPA","Inclusion criteria:\n\n* Male (based on chromosomal composition at birth) and aged greater than or equal to (\\>=) 18 years.\n* Must have a histologically or cytologically confirmed diagnosis of prostate adenocarcinoma\n* Must have documented metastatic hormone-sensitive prostate cancer (mHSPC)\n* Must have agreed with the treating physician to initiate treatment with apalutamide (plus androgen-deprivation therapy \\[ADT\\]) in accordance with the current product characteristics summary, based on the physician's decision, prior to study inclusion\n* Able to understand the content of the patient information sheet and has provided oral consent for data collection. Has received the information sheet and has not objected to data collection\n* Must have a baseline prostate-specific antigen (PSA) level collected prior to the first administration of apalutamide.\n* Must agree to complete adherence and quality-of-life questionnaires during the study, including before the first administration of apalutamide\n\nExclusion criteria:\n\n* Has already received or is currently receiving apalutamide, or any other androgen receptor pathway inhibitor (ARPI; including but not limited to abiraterone acetate, darolutamide, and enzalutamide) or chemotherapy for mHSPC\n* Has received an investigational drug (including vaccines) or used an invasive investigational medical device within 90 days prior to study start or data collection\n* Is currently receiving active treatment for prostate cancer as part of an interventional study\n* Has received ADT for mHSPC for more than 4 months prior to starting apalutamide treatment\n* Has experienced progression under ADT (and thus became castration-resistant) before starting apalutamide treatment\n* Beneficiary of State Medical Aid \\[AME\\]\n* Does not speak\u002Fread French\n* Under guardianship or curatorship\n* Under judicial protection",{"count":113,"type":20},270,"This study aims to explore the real-world treatment adherence, persistence of apalutamide, and assess the risk of non-adherence according to the participant's profile and behavior of metastatic hormone-sensitive prostate cancer (mHSPC) participants treated with apalutamide during the first year of continued treatment.",[116,25],"Prostatic Neoplasms",[56,118],"mHSPC","2026-06-04",{"date":63,"type":30},{"date":122,"type":30},"2025-12-18",{"date":124,"type":20},"2028-01-03",{"name":126,"class":37},"Janssen Cilag S.A.S.",{"id":128,"slug":129,"hasResults":11,"nctId":130,"briefTitle":131,"officialTitle":132,"acronym":4,"eligibilityCriteria":133,"healthyVolunteers":11,"sex":16,"minAge":46,"maxAge":4,"enrollmentInfo":134,"targetDuration":4,"studyType":49,"phases":136,"briefSummary":138,"conditions":139,"keywords":4,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":119,"lastUpdatePostDateStruct":141,"startDateStruct":142,"completionDateStruct":144,"leadSponsor":146,"locationsCount":148},"100502163","phase-1-a-study-of-pasritamig-jnj-78278343-in-combination-with-other-agents-for-metastatic-prostate-cancer-100502163","NCT05818683","A Study of Pasritamig (JNJ-78278343) in Combination With Other Agents for Metastatic Prostate Cancer","A Phase 1b Study of JNJ-78278343, Targeting Human Kallikrein 2 (KLK2) in Combination With Other Agents for Metastatic Prostate Cancer","Inclusion Criteria:\n\n* Part 1 A-G, 1I, 1J, and 1K (all combination treatments) and Parts 2B-C (cabazitaxel, docetaxel): Metastatic castration-resistant prostate cancer (mCRPC) with confirmed adenocarcinoma of the prostate as defined by prostate cancer working group 3 (PCWG3); Parts 2D-G, 2I, 2J, and 2K (apalutamide, enzalutamide, darolutamide, abiraterone acetate + prednisone \\[AAP\\], lutetium Lu-177 vipivotide tetraxetan, JNJ-101556143): mCRPC: Histologically confirmed adenocarcinoma of the prostate as defined by PCWG3, with a minimum PSA of 2 nanogram \\[ng\\]\u002Fmilliliter (mL); Part 2H (apalutamide): metastatic hormone-sensitive prostate cancer(mHSPC) with PSA greater than (\\>) 0.2 ng\u002FmL on 6 to 24 months of treatment with a next generation ARPI (apalutamide, enzalutamide, darolutamide, or abiraterone)\n* Measurable or evaluable disease, except for Part 2H\n* (a) Part 1A (cetrelimab) - Prior treatment for mCRPC with at least 1 prior androgen receptor pathway inhibitors (ARPI) (that is, abiraterone acetate, apalutamide, enzalutamide, darolutamide), or chemotherapy (example, docetaxel). (b) Part 1C and 2C (docetaxel), Part 1D (apalutamide), Part 1E and 2E (enzalutamide), Part 1F and 2F (darolutamide), and Part 1G, 2G (AAP), and Part 1K \\& 2K (JNJ-101556143)- Prior treatment with at least 1 prior ARPI (that is, apalutamide, enzalutamide, darolutamide, or abiraterone acetate). (C) Part 1B and 2B (cabazitaxel) - Prior treatment with at least 1 prior ARPI (ie, abiraterone acetate, apalutamide, enzalutamide, darolutamide) and docetaxel. (d) Part 2D (apalutamide) - Prior treatment with at least 1 prior ARPI (e) Part 2H (apalutamide)- Participant may have received up to 6 cycles of docetaxel. The last dose of docetaxel must be administered at least 2 months prior to enrollment (f) Parts 1I, 1J, 2I \\& 2J (lutetium Lu-177 vipivotide tetraxetan)- Prior treatment with at least 1 ARPI (abiraterone acetate, enzalutamide, darolutamide, or apalutamide). Participant must not have received prior cytotoxic chemotherapy or prior radioligand therapy (RLT) for mCRPC\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1\n* Adequate organ functions\n\nExclusion Criteria:\n\n* Active autoimmune disease within the 12 months prior to signing consent that requires systemic immunosuppressive medications\n* Toxicity related to prior anticancer therapy that has not returned to Grade less than or equal to (\\\u003C=) 1 or baseline levels (except for alopecia, vitiligo, Grade \\\u003C=2 peripheral neuropathy)\n* Solid organ or bone marrow transplantation\n* Known allergies, or intolerance to any of the components (example, excipients) of pasritamig, cetrelimab (Part 1A), cabazitaxel, Part 1B and 2B , docetaxel Part 1C and 2C , apalutamide (Part 1D and 2D and Part 2H), enzalutamide (Part 1E and 2E), darolutamide (Part 1F and 2F), or AAP (Part 1G and 2G), lutetium Lu-177 vipivotide tetraxetan (Parts 1I, 1J, 2I, and 2J), or JNJ-101556143 (Parts 1K \\& 2K)\n* Significant infections or serious lung, heart or other medical conditions",{"count":135,"type":20},300,[137],"PHASE1","The purpose of this study is to identify the recommended phase 2 regimen(s) RP2R(s) of pasritamig and combination regimens in Part 1 (dose escalation) and to determine safety at the putative RP2R(s) of pasritamig with the combination regimens in Part 2 (dose expansion).",[140,25],"Metastatic Castration-resistant Prostate Neoplasms",{"date":63,"type":30},{"date":143,"type":30},"2023-04-26",{"date":145,"type":20},"2028-05-23",{"name":147,"class":37},"Janssen Research & Development, LLC",15,{"id":150,"slug":151,"hasResults":11,"nctId":152,"briefTitle":153,"officialTitle":154,"acronym":4,"eligibilityCriteria":155,"healthyVolunteers":11,"sex":16,"minAge":46,"maxAge":4,"enrollmentInfo":156,"targetDuration":4,"studyType":49,"phases":158,"briefSummary":159,"conditions":160,"keywords":163,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":166,"lastUpdatePostDateStruct":167,"startDateStruct":169,"completionDateStruct":171,"leadSponsor":173,"locationsCount":175},"100593339","phase-2-a-phase-2-study-to-evaluate-the-effects-of-asp5541-in-participants-with-prostate-cancer-100593339","NCT07005154","A Phase 2 Study to Evaluate the Effects of ASP5541 in Participants With Prostate Cancer","A Phase 2, Open-label, Multi-cohort Study to Assess the Efficacy and Safety of ASP5541 in Participants With Advanced Prostate Cancer","Inclusion Criteria:\n\n* Participant is diagnosed with histologically or cytologically confirmed adenocarcinoma of the prostate without neuroendocrine differentiation or small cell features.\n* Participant has ECOG performance status of 0 or 1, or ECOG performance status of 2 if due to bone pain.\n* Participant must have an estimated life expectancy of ≥ 12 months with mHSPC or ≥ 6 months with mCRPC.\n* Participant is able to understand and comply with all study requirements and procedures.\n* Participant has been diagnosed with mCRPC or mHSPC documented by metastatic lesions on a bone scan, computed tomography (CT), magnetic resonance imaging (MRI) or prostate-specific membrane antigen positron emission tomography (PSMA-PET).\n* Participant is receiving ongoing ADT with a gonadotropin-releasing hormone (GnRH) analogue or has a history of bilateral orchiectomy (i.e., surgical or medical castration). Participant with mHSPC must have started castration therapy (medical or surgical) at least 14 days prior to Cycle 1 Day 1 (C1D1).\n\nNote: Participant who has not had a bilateral orchiectomy must have a plan to maintain effective GnRH analogue therapy for the duration of the study.\n\n* If the participant has mCRPC, participant has evidence of disease progression defined as 1 or more of the following criteria at study entry:\n\n  * Evidence of radiographic progression of disease prior to first dose and following the most recent prostate cancer treatment, defined as progressive disease on CT\u002FMRI per Response Evaluation Criteria in Solid Tumours (RECIST) v1.1 or on a bone scan per PCWG3.\n  * PSA progression defined as an increase in PSA of at least 25% and ≥ 1 ng\u002FmL above the nadir, confirmed by a second value 1 week later, and with at least 1 of the measurements within 90 days prior to screening. PSA nadir is defined as the lowest PSA during or after the most recent treatment.\n* If the participant has mCRPC, participant has a serum testosterone level \\\u003C 1.73 nmol\u002FL (\\\u003C 50 ng\u002FdL) at the Screening visit.\n* Male participant must agree to use contraception with female partner(s) of childbearing potential (including breastfeeding partner) throughout the treatment period and for 7 months after final ASP5541 administration.\n* Male participant must agree to remain abstinent or use a condom with pregnant partner(s) for the duration of the pregnancy throughout the investigational period and for 7 months after final ASP5541 administration.\n* Male participant must not donate sperm during the treatment period and for 7 months after final ASP5541 administration.\n* Participant agrees not to participate in another interventional study while receiving ASP5541 in the present study.\n* Participant should have normal serum potassium (within the local laboratory normal range) at screening without supplementation.\n\nExclusion Criteria:\n\n* Participant has any concurrent disease, infection or comorbid condition that interferes with the ability of the subject to participate in the study, which places the subject at undue risk or complicates the interpretation of data.\n* Participant has known active central nervous system (CNS) metastases. Note: Participant with CNS metastases who has been treated with surgery and\u002For radiation therapy, who is off pharmacologic doses of glucocorticoids and who is neurologically stable is eligible.\n* Participant has a known additional malignancy beyond prostate cancer that requires active treatment with the exception of any of the following:\n\n  * Adequately treated basal cell carcinoma, squamous cell carcinoma of the skin, or in situ carcinoma of any type\n  * Adequately treated Stage I cancer from which the participant is currently in remission and has been in remission for ≥ 2 years\n  * Any other cancer from which the participant has been disease-free for ≥5 years\n* Participant has clinically significant cardiac disease, defined as any of the following:\n\n  * Clinically significant cardiac arrhythmias including bradyarrhythmia which are poorly controlled. Rate-controlled atrial fibrillation is permitted.\n  * Congenital long QT syndrome.\n  * QT interval corrected by Fridericia's formula (QTcF) ≥450 msec at Screening. If the QT interval corrected for heart rate intervals (QTc) is prolonged in a participant with a pacemaker or bundle branch block, the participant may be enrolled in the study if confirmed by the medical monitor.\n  * History of clinically significant cardiac disease or congestive heart failure greater than New York Heart Association (NYHA) Class II or left ventricular ejection fraction measurement of \\\u003C 50% at baseline.\n  * Cohorts 1 and 3: Participant must not have unstable angina (symptoms at rest) or new-onset angina within the last 3 months or myocardial infarction within the past 6 months.\n  * Cohort 2: Participants must not have symptomatic heart failure, unstable or new-onset angina or myocardial infarction within the past 12 months.\n  * Cohorts 1 and 3: Uncontrolled hypertension, defined as systolic blood pressure \\> 160 mmHg or diastolic blood pressure \\> 100 mmHg that has been confirmed by 2 successive measurements despite optimal medical management.\n  * Cohort 2: Uncontrolled hypertension, defined as systolic BP \\> 140 mmHg or diastolic BP \\> 90 mmHg that has been confirmed by 2 successive measurements despite optimal medical management. Participants may be receiving a maximum of 2 antihypertensives that were initiated at least 3 months prior to Cycle 1 Day 1.\n  * Cohort 1 and 3: Arterial or venous thrombotic or embolic events such as cerebrovascular accident (including transient ischemic attacks), deep vein thrombosis, or pulmonary embolism within the 3 months before start of study medication (except for adequately treated catheter related venous thrombosis occurring \\> 1 month before Cycle 1 Day 1).\n  * Cohort 2: Arterial thrombotic or embolic events such as cerebrovascular accident (including transient ischemic attacks) within the last 12 months.\n* Participant has any unresolved National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) (version 5.0) Grade \\> 2 toxicity at the Screening visit. Note: Participant receiving ongoing hormone replacement therapy for endocrine immune-related AEs without clinical symptoms will not be excluded.\n* Participant has had major surgery (e.g., requiring general anesthesia) within 30 days before screening, or has not fully recovered from surgery, or has major surgery planned during the time the participant is expected to participate in the study.\n* Participant has\u002Fhad febrile illness or symptomatic, viral, bacterial (including upper respiratory infection) or fungal (noncutaneous) infection within 28 days prior to day 1.\n* Participant received a blood transfusion within 1 month of the first dose of study intervention.\n* Participant has a history of impaired pituitary or adrenal gland function (e.g., Addison's disease, Cushing's syndrome).\n* Participant has hemoglobin A1c (HbA1c) \\> 10% (if diabetes mellitus was previously diagnosed) or HbA1c \\> 8% (if diabetes mellitus was previously undiagnosed). (Excluded participant may be rescreened after referral and evidence of improved control of their condition.)\n* Participant has jaundice or known current active liver disease from any cause, including hepatitis A (hepatitis A virus IgM positive, but testing for hepatitis A in screening is not required), hepatitis B (hepatitis B virus surface antigen positive, confirmed by hepatitis B virus DNA), or hepatitis C (hepatitis C virus antibody positive, confirmed by hepatitis C virus RNA).\n* Participant has moderate or severe hepatic impairment (Child-Pugh Class B or C).\n* Participant has a known history of human immunodeficiency virus (HIV) infection (HIV antibody positive).\n* Participant has a body mass index \\> 40 kg\u002Fm2.\n* Participant has a history of drug or alcohol abuse according to Diagnostic and Statistical Manual of Mental Disorders, 5th edition criteria within 2 years before screening.\n* Participant received treatment with glucocorticoids greater than the equivalent of 10 mg per day of prednisone within 4 weeks prior to C1D1. The use of topical, intraocular, inhalational, intranasal or intra-articular glucocorticoids is permitted.\n* Participant received treatment with herbal medications with known anti-cancer properties or known effects on prostate physiology within 4 weeks prior to Cycle 1 Day 1 (e.g., saw palmetto, St. John's wort, turmeric\u002Fcurcumin). Participants must agree not to use herbal products during study participation.\n* Participant is receiving current treatment with systemic ketoconazole, abiraterone acetate (AA) or any other cytochrome P450 17A1 (CYP17) inhibitor. Participant who has received systemic ketoconazole, AA or any other CYP17 inhibitor must have discontinued these agents ≥ 4 weeks prior to the first dose of study intervention.\n* Participant received prior systemic treatment with a strong inducer or inhibitor of cytochrome p450 3A4 (CYP3A4) within 4 weeks of first dose of study intervention. Concomitant use of strong inducers or inhibitors of CYP3A4 are not permitted on study.\n* Participant requires use of biotin (i.e., vitamin B7) or supplements containing biotin higher than the daily adequate intake of 30 μg. Note: Participant who switches from a high dose to a dose of 30 μg\u002Fday or less prior to first dose of study drug is eligible for study entry.\n* Participant is required to use any prohibited medication on the List of Excluded Concomitant Medications.\n* For mCRPC participants only: Participant has been treated with any of the following for prostate cancer, during the indicated time frame prior to enrollment:\n\n  * Hormonal therapy (e.g., androgen receptor blockers \\[AR\\] antagonists, second-generation androgen receptor pathway inhibitors \\[including enzalutamide, apalutamide, darolutamide, rezvilutamide and AA\\], 5-alpha reductase inhibitors, estrogens, cyproterone acetate) within 4 weeks of C1D1. Note: Participant has been treated with bicalutamide within 6 weeks prior to enrollment is not permitted. Participant has been treated with all other GnRH analogues or antagonists is permitted.\n  * Chemotherapy within 2 weeks or 5 half-lives of C1D1 (whichever is longer)\n  * Biologic therapy within 4 weeks of C1D1\n  * Immunotherapy within 4 weeks of C1D1\n  * Radiation therapy (includes radioligands) within 4 weeks of C1D1\n* For mHSPC participants only: Participant has received any prior pharmacotherapy, radiation therapy or surgery for metastatic prostate cancer (the following exceptions are permitted):\n\n  * Up to 4 months of ADT with GnRH agonists or antagonists or orchiectomy (within 3 months prior to C1D1) with or without concurrent antiandrogens.\n  * Participant may have 1 course of palliative radiation or surgical therapy to treat symptoms resulting from metastatic disease if it was administered at least 4 weeks prior to C1D1.\n  * Up to 6 cycles of docetaxel therapy, with the last dose of docetaxel ≤ 2 months prior to C1D1. A participant who has received docetaxel should have maintained a response to docetaxel of stable disease or better, by imaging and PSA, prior to C1D1.\n  * Up to 6 months of ADT with GnRH agonists or antagonists or orchiectomy with or without concurrent antiandrogens prior to C1D1 if subject was treated with docetaxel, with no radiographic evidence of disease progression or rising PSA levels prior to C1D1.\n* Participant has received any investigational therapy within 4 weeks or 5 half-lives (whichever is longer) prior to C1D1.\n* Participant has received ASP5541 previously.\n* Participant has absolute neutrophil count \\\u003C 1500\u002FμL, platelet count \\\u003C 100000\u002FμL or hemoglobin \\\u003C 9 g\u002FdL (6.2 mmol\u002FL) or international normalized ratio (INR) ≥ 1.5 (unless participant is taking oral anticoagulants in which case INR ≤ 2.0 is permitted) at Screening. Note: Participant may not have received any growth factors within 7 days or blood transfusions within 28 days prior to the hematology values obtained at Screening.\n* Participant has serum total bilirubin \\> 1.5 x upper limit of normal (ULN) (or \\> 3 x ULN for participants with documented Gilbert's disease), or serum alanine aminotransferase or aspartate aminotransferase \\> 2.5 x ULN at Screening.\n* Participant does not have adequate renal function defined as a calculated creatinine clearance \\\u003C 30 mL\u002Fmin as determined by a validated algorithm for calculating creatinine clearance.\n* Participant has serum albumin \\\u003C 3.0 g\u002FdL (30 g\u002FL) at Screening.\n* Participant has a known or suspected hypersensitivity to ASP5541, prednisone, or any components of the formulations used.\n* Participant has a gastrointestinal disorder affecting absorption.",{"count":157,"type":20},218,[80],"Hormone therapy, or androgen deprivation therapy (ADT) is a standard way to treat prostate cancer. It works by reducing the amount of the main male sex hormone, testosterone in the body. Androgen receptor pathway inhibitors (ARPIs) are another type of hormone therapy. They either slow down how much testosterone is made or block testosterone from reaching the prostate cancer cells. Abiraterone acetate (AA) is an ARPI that is used to treat advanced prostate cancer. This type of treatment is usually given as a tablet with a steroid called prednisone\u002Fprednisolone to manage any medical problems from the hormone therapy.\n\nASP5541 is a different form of abiraterone acetate. It is given as an injection into the muscle. In this study, ASP5541 will be given to men with advanced prostate cancer, both with and without prednisone\u002Fprednisolone. This study will check the safety of ASP5541 and compare how well ASP5541 works in men with advanced prostate cancer compared to abiraterone acetate.\n\nThe main aims of the study are:\n\n* To check how well ASP5541 with prednisone\u002Fprednisolone works compared to AA with prednisone\u002Fprednisolone in men with advanced prostate cancer who haven't previously been treated with an ARPI.\n* To check the safety of ASP5541 given by itself in men with advanced prostate cancer that haven't previously been treated with an ARPI.\n* To check how well ASP5541 given by itself works compared to AA with prednisone\u002Fprednisolone in men with advanced prostate cancer that haven't previously been treated with an ARPI.\n* To check the safety of ASP5541 with prednisone\u002Fprednisolone in Japanese men with advanced prostate cancer.\n\nAdult men with a certain type of advanced prostate cancer can take part. Their cancer has spread to other parts of the body (metastatic). The different types are:\n\n* Metastatic hormone-sensitive prostate cancer (mHSPC). Prostate cancer that needs testosterone to grow.\n* Metastatic castration-resistant prostate cancer (mCRPC). Prostate cancer that continues to grow even when testosterone levels are low.\n\nIn this study there will be 3 treatment groups:\n\n* In Group 1, men with mCRPC who haven't previously been treated with an androgen receptor pathway inhibitor will either be given ASP5541 and prednisone\u002Fprednisolone or be given abiraterone acetate and prednisone\u002Fprednisolone.\n* In Group 2, men with mHSPC who haven't previously been treated with an androgen receptor pathway inhibitor will either be given ASP5541 by itself or be given abiraterone acetate with prednisone\u002Fprednisolone.\n* In Group 3, Japanese men with mCRPC or mHSPC who may or may not have previously been treated with an androgen receptor pathway inhibitor will be given ASP5541 with prednisone\u002Fprednisolone.\n\nASP5541 will be given as an injection into a muscle every 12 weeks. Men with mCRPC will take prednisone\u002Fprednisolone twice daily and men with mHSPC will take prednisone\u002Fprednisolone once daily. Abiraterone acetate will be given as tablets to be taken once daily. All groups will also receive the standard of care treatment, such as androgen deprivation therapy.\n\nThe men in the study will visit their clinic regularly during and after treatment for health checks, including checking for any medical problems. Some men (Group 2) will check their blood pressure weekly at home. On some visits they will also have scans to check for any changes in their cancer. The number of visits and type of safety checks done at each visit will depend on the health of each person and when they completed their treatment.",[55,161,162],"Metastatic Castration-Resistant Prostate Cancer","Metastatic Hormone Sensitive Prostate Cancer",[164,165],"ASP5541","PRL-02","2026-04-30",{"date":168,"type":30},"2026-05-01",{"date":170,"type":30},"2025-06-19",{"date":172,"type":20},"2032-05-31",{"name":174,"class":37},"Astellas Pharma Global Development, Inc.",33,{"id":177,"slug":178,"hasResults":11,"nctId":179,"briefTitle":180,"officialTitle":181,"acronym":182,"eligibilityCriteria":183,"healthyVolunteers":11,"sex":16,"minAge":46,"maxAge":4,"enrollmentInfo":184,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":186,"conditions":187,"keywords":4,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":189,"lastUpdatePostDateStruct":190,"startDateStruct":192,"completionDateStruct":194,"leadSponsor":196,"locationsCount":38},"100624180","a-study-to-learn-about-real-world-utilization-and-outcomes-of-darolutamide-and-other-androgen-receptor-pathway-inhibitors-arpis-for-newly-diagnosed-metastatic-hormone-sensitive-prostate-cancer-de-novo-mhspc-in-us-urology-clinics-100624180","NCT07406282","A Study to Learn About Real-world Utilization and Outcomes of Darolutamide and Other Androgen Receptor Pathway Inhibitors (ARPIs) for Newly Diagnosed Metastatic Hormone-sensitive Prostate Cancer (de Novo mHSPC) in US Urology Clinics","Double-DARE: Analysis of Doublet and Triplet Therapy With Darolutamide and Other Androgen Receptor Pathway Inhibitors in de Novo mHSPC Patients Seen in Urology Clinics in the USA","Double-DARE","Inclusion Criteria:\n\n* Male patients with evidence of de novo mHSPC during the study period\n* Initiation of ARPI therapy during the patient identification period and within ±90 days from the mHSPC diagnosis\n* Age ≥18 years at index date (ARPI initiation for mHSPC)\n* Initiation of ADT and\u002For docetaxel therapy within ±90 days from index date\n* At least 90 days of EMR activity prior to the index date\n* At least 90 days of EMR activity post-index, unless the patient died earlier.\n\nExclusion Criteria:\n\n* History of other primary cancers (except non-melanoma skin cancer)\n* Use of PARP inhibitors, chemotherapy (other than docetaxel), immunotherapy or radiopharmaceuticals prior to index date\n* Evidence of castration resistance (CR) flag in the database any time before the index date or up to 90 days after the de novo mHSPC diagnosis\n* Clinical trial participation during the study period.",{"count":185,"type":20},1400,"Prostate cancer is the most common non-skin cancer among men in the United States. For some men, the cancer has already spread to other parts of the body at the time of diagnosis; this is called metastatic hormone-sensitive prostate cancer (mHSPC). Treatment for mHSPC has advanced significantly, with new standards of care involving androgen deprivation therapy (ADT) combined with drugs known as androgen receptor pathway inhibitors (ARPIs), sometimes alongside chemotherapy like docetaxel. Darolutamide is an ARPI that is approved by the FDA for treating mHSPC in a \"triplet\" combination with ADT and docetaxel. It is also used in a \"doublet\" combination with ADT alone. However, there is limited information on how darolutamide is used in real-world clinical settings for this condition, which creates a gap in knowledge for making treatment decisions. This study aims to fill that gap by analyzing real-world data from electronic medical records. The primary goal is to describe the characteristics of patients with newly diagnosed mHSPC who are treated with darolutamide (either as a doublet or triplet) in urology clinics across the US. The study will also examine drug use patterns and clinical outcomes for these patients. Additionally, the study will explore the characteristics of patients treated with other ARPIs (abiraterone acetate, enzalutamide, and apalutamide) and assess the feasibility of creating matched patient groups for future comparative research. Data will be collected retrospectively from a large network of community urology practices in the US.",[116,188],"Metastatic Hormone-Sensitive Prostate Cancer","2026-04-08",{"date":191,"type":30},"2026-04-09",{"date":193,"type":30},"2025-07-22",{"date":195,"type":20},"2026-05-31",{"name":36,"class":37},{"id":198,"slug":199,"hasResults":11,"nctId":200,"briefTitle":201,"officialTitle":201,"acronym":4,"eligibilityCriteria":202,"healthyVolunteers":11,"sex":16,"minAge":46,"maxAge":4,"enrollmentInfo":203,"targetDuration":4,"studyType":49,"phases":205,"briefSummary":206,"conditions":207,"keywords":4,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":209,"lastUpdatePostDateStruct":210,"startDateStruct":212,"completionDateStruct":214,"leadSponsor":216,"locationsCount":218},"100494588","phase-1-phase-ibiia-dose-escalation-and-expansion-study-of-pbpb-advc001-in-metastatic-prostate-cancer-therapb---phase-iii-study-100494588","NCT05720130","Phase Ib\u002FIIa Dose Escalation and Expansion Study of [²¹²Pb]Pb-ADVC001 in Metastatic Prostate Cancer (TheraPb - Phase I\u002FII Study).","Key Inclusion Criteria:\n\n* Documented metastatic adenocarcinoma of the prostate, confirmed by histopathology.\n* Progressive metastatic prostate cancer demonstrated by at least one of the following:\n\n  1. Increase in PSA greater than 25% and \\> 2 ng\u002FmL above nadir, confirmed by progression at two timepoints at least three weeks apart\n  2. Progressive disease or new lesion(s) (relative to previous imaging) in the viscera or lymph nodes as per the Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 or in bone as per Prostate Cancer Clinical Trials Working Group 3 (PCWG3).\n* For Phase 1b Dose Escalation: Metastatic castration-resistant prostate cancer (mCRPC) with exposure to at least one ARPi and taxane-based chemotherapy at any time in the course of their disease (unless taxanes considered contraindicated or declined by participant as documented in the patient's source documents and eCRF).\n* For Phase 2a Dose Expansion:\n\n  1. Group 1: Metastatic hormone-sensitive prostate cancer (mHSPC) with a sub-optimal PSA response defined as PSA ≥ 0.2 ng\u002FmL despite receiving androgen deprivation therapy (ADT) and an androgen receptor pathway inhibitor (ARPi) without evidence of disease progression\n  2. Group 2: Progressive mCRPC post ≥ 1 ARPi; 177Lutetium (177Lu)-PSMA-naïve and not previously treated with chemotherapy for CRPC\n  3. Group 3: Progressive mCRPC with prior exposure to 177Lu-PSMA and ARPi\n* Has disease that is prostate specific membrane antigen (PSMA) positive, as demonstrated by ⁶⁸Ga-PSMA-PET\u002FCT or ¹⁸F-based PSMA PET\u002FCT and confirmed as eligible by local reader. PSMA-positive participants are defined as those having at least one tumor lesion with ⁶⁸Ga- or ¹⁸F- PSMA PET CT uptake greater than normal liver (based on visual assessment) and all tumor lesions larger than size criteria with ⁶⁸Ga- or ¹⁸F-PSMA uptake greater than liver \\[short axis size criteria: organs ≥ 1 cm, lymph nodes ≥ 2.5 cm, bones (soft tissue component) ≥ 1 cm\\].\n* Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1.\n* Adequate haematological, renal, and liver function.\n\nKey Exclusion Criteria:\n\n* Has received prior systemic radioligand therapy with the exception of prior radium-223. Prior 177Lu-PSMA is required for Phase 2a Group 3 participants.\n* Systemic anti-cancer therapy and\u002For radiation therapy within four weeks of C1D1 or has received any investigational agent within four weeks of C1D1.\n* Has malignancies other than prostate cancer within 3 years prior to enrolment, except for those with a negligible risk of metastases\n* Known CNS metastases or symptoms of spinal cord compression or impending spinal cord compression. Patients with prior treatment for spinal cord compression should be clinically stable off steroids for at least 4 weeks.\n* Has diffuse bone-marrow involvement, i.e, \"superscan\", defined as bone scintigraphy in which there is excessive skeletal radioisotope uptake.\n* Has a serious active or sub-clinical infection, or angina pectoris, or heart failure (New York Heart Association \\[NYHA\\] Class III or IV), or significantly prolonged QT interval, or other serious illness which might impair the ability to participate in this study to the full extent, or which may require treatment that could interact with study treatment.\n* Has a known alteration in breast cancer genes (BRCA) BRCA1 or BRCA2 and are eligible to receive poly ADP ribose polymerase (PARP) inhibitor therapy according to their treating institution's standard of care.",{"count":204,"type":20},100,[137,80],"This is a prospective, open-label, dose-escalation and randomized dose optimization and expansion study. The Phase Ib portion of the study aims to determine the safety and tolerability of escalating doses of \\[212Pb\\]Pb-ADVC001 administered every 6, 4, 2 or 1 week(s) and establish the recommended phase 2 doses (RP2D). The Phase 2a expansion aims to assess the efficacy and safety of \\[212Pb\\]Pb-ADVC001 at the RP2 doses in 3 participant groups.",[55,208,162],"Metastatic Castration-resistant Prostate Cancer","2026-02-18",{"date":211,"type":30},"2026-02-20",{"date":213,"type":30},"2023-03-15",{"date":215,"type":20},"2029-06-01",{"name":217,"class":37},"AdvanCell Pty Limited",3,{"id":220,"slug":221,"hasResults":11,"nctId":222,"briefTitle":223,"officialTitle":224,"acronym":4,"eligibilityCriteria":225,"healthyVolunteers":11,"sex":16,"minAge":46,"maxAge":226,"enrollmentInfo":227,"targetDuration":4,"studyType":49,"phases":229,"briefSummary":230,"conditions":231,"keywords":232,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":234,"lastUpdatePostDateStruct":235,"startDateStruct":236,"completionDateStruct":238,"leadSponsor":240,"locationsCount":38},"100619026","phase-1-a-study-to-evaluate-the-safety-and-drug-levels-of-asp5541-in-chinese-participants-with-prostate-cancer-100619026","NCT07339267","A Study to Evaluate the Safety and Drug Levels of ASP5541 in Chinese Participants With Prostate Cancer","A Phase 1, Open-label Study to Evaluate the Pharmacokinetics and Safety of ASP5541 in Chinese Participants With Advanced Prostate Cancer","Inclusion Criteria:\n\n* Participant is diagnosed with histologically or cytologically confirmed adenocarcinoma of the prostate without neuroendocrine differentiation or small cell features.\n* Participant has Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1, or ECOG performance status of 2 if due to bone pain.\n* Participant must have an estimated life expectancy of ≥ 12 months with metastatic hormone-sensitive prostate cancer (mHSPC) or ≥ 6 months with metastatic castration-resistant prostate cancer (mCRPC).\n* Participant is able to understand and comply with all study requirements and procedures.\n* Participant has been diagnosed with mCRPC or mHSPC documented by metastatic lesions on a bone scan, computed tomography (CT), magnetic resonance imaging (MRI) or prostate-specific membrane antigen positron emission tomography (PSMA-PET).\n* Participant is receiving ongoing androgen deprivation therapy (ADT) with a gonadotropin-releasing hormone (GnRH) analogue or has a history of bilateral orchiectomy (i.e., surgical or medical castration). Participant with mHSPC must have started castration therapy (medical or surgical) at least 14 days prior to Cycle 1 Day 1 (C1D1).\n\nNote: Participant who has not had a bilateral orchiectomy must have a plan to maintain effective GnRH analogue therapy for the duration of the study.\n\n* If the participant has mCRPC, participant has evidence of disease progression defined as 1 or more of the following criteria at study entry:\n\n  * Evidence of radiographic progression of disease prior to first dose and following the most recent prostate cancer treatment, defined as progressive disease on CT\u002FMRI per Response Evaluation Criteria in Solid Tumours (RECIST) v1.1 or on a bone scan per PCWG3.\n  * PSA progression defined as an increase in PSA of at least 25% and ≥ 1 ng\u002FmL above the nadir, confirmed by a second value 1 week later, and with at least 1 of the measurements within 90 days prior to screening. PSA nadir is defined as the lowest PSA during or after the most recent treatment.\n* If the participant has mCRPC, participant has a serum testosterone level \\\u003C 1.73 nmol\u002FL (\\\u003C 50 ng\u002FdL) at the Screening visit.\n* Male participant must agree to use contraception with female partner(s) of childbearing potential (including breastfeeding partner) throughout the treatment period and for 7 months after final ASP5541 administration.\n* Male participant must agree to remain abstinent or use a condom with pregnant partner(s) for the duration of the pregnancy throughout the investigational period and for 7 months after final ASP5541 administration.\n* Male participant must not donate sperm during the treatment period and for 7 months after final ASP5541 administration.\n* Participant has adequate ventrogluteal muscle mass for an intramuscular injection.\n* Participant agrees not to participate in another interventional study while receiving ASP5541 in the present study.\n\nExclusion Criteria:\n\n* Participant has any concurrent disease, infection or comorbid condition that interferes with the ability of the subject to participate in the study, which places the subject at undue risk or complicates the interpretation of data.\n* Participant has known active central nervous system (CNS) metastases. Note: Participant with CNS metastases who has been treated with surgery and\u002For radiation therapy, who is off pharmacologic doses of glucocorticoids and who is neurologically stable is eligible.\n* Participant has a known additional malignancy beyond prostate cancer that requires active treatment with the exception of any of the following:\n\n  * Adequately treated basal cell carcinoma, squamous cell carcinoma of the skin, or in situ carcinoma of any type\n  * Adequately treated Stage I cancer from which the participant is currently in remission and has been in remission for ≥ 2 years\n  * Any other cancer from which the participant has been disease-free for ≥5 years\n* Participant has clinically significant cardiac disease, defined as any of the following:\n\n  * Clinically significant cardiac arrhythmias including bradyarrhythmia which are poorly controlled. Rate-controlled atrial fibrillation is permitted.\n  * Congenital long QT syndrome.\n  * QT interval corrected by Fridericia's formula (QTcF) ≥450 msec at Screening. If the QT interval corrected for heart rate intervals (QTc) is prolonged in a participant with a pacemaker or bundle branch block, the participant may be enrolled in the study if confirmed by the medical monitor.\n  * History of clinically significant cardiac disease or congestive heart failure greater than New York Heart Association (NYHA) Class II or left ventricular ejection fraction measurement of \\\u003C 50% at baseline. Participant must not have unstable angina (symptoms at rest) or new-onset angina within the last 3 months or myocardial infarction within the past 6 months.\n  * Uncontrolled hypertension, defined as systolic blood pressure \\> 160 mmHg or diastolic blood pressure \\> 100 mmHg that has been confirmed by 2 successive measurements despite optimal medical management.\n  * Arterial or venous thrombotic or embolic events such as cerebrovascular accident (including transient ischemic attacks), deep vein thrombosis, or pulmonary embolism within the 3 months before start of study medication (except for adequately treated catheter related venous thrombosis occurring \\> 1 month before the start of study medication).\n* Participant has any unresolved National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) (version 5.0) Grade \\> 2 toxicity at the Screening visit. Note: Participant receiving ongoing hormone replacement therapy for endocrine immune-related AEs without clinical symptoms will not be excluded.\n* Participant has had major surgery (e.g., requiring general anesthesia) within 90 days before screening, or will not have fully recovered from surgery, or has major surgery planned during the time the participant is expected to participate in the study.\n* Participant has\u002Fhad febrile illness or symptomatic, viral, bacterial (including upper respiratory infection) or fungal (noncutaneous) infection within 28 days prior to day 1.\n* Participant received a blood transfusion within 1 month of the first dose of study intervention.\n* Participant has a history of impaired pituitary or adrenal gland function (e.g., Addison's disease, Cushing's syndrome).\n* Participant has hemoglobin A1c (HbA1c) \\> 10% (if diabetes mellitus was previously diagnosed) or HbA1c \\> 8% (if diabetes mellitus was previously undiagnosed). (Excluded participant may be rescreened after referral and evidence of improved control of their condition.)\n* Participant has jaundice or known current active liver disease from any cause, including hepatitis A (hepatitis A virus IgM positive, but testing for hepatitis A in screening is not required), hepatitis B (hepatitis B virus surface antigen positive, confirmed by hepatitis B virus DNA), or hepatitis C (hepatitis C virus antibody positive, confirmed by hepatitis C virus RNA).\n* Participant has moderate or severe hepatic impairment (Child-Pugh Class B or C).\n* Participant has a known history of human immunodeficiency virus (HIV) infection (HIV antibody positive).\n* Participant has a body mass index \\> 40 kg\u002Fm2.\n* Participant has a history of drug or alcohol abuse according to Diagnostic and Statistical Manual of Mental Disorders, 5th edition criteria within 2 years before screening.\n* Participant received treatment with glucocorticoids greater than the equivalent of 10 mg per day of prednisone within 4 weeks prior to C1D1. The use of topical, intraocular, inhalational, intranasal or intra-articular glucocorticoids is permitted.\n* Participant received treatment with Chinese traditional medications with known antitumor activity or herbal products within 4 weeks prior to C1D1 (e.g., saw palmetto). Participant must agree not to use such Chinese traditional medications or herbal products during study participation.\n* Participant is receiving current treatment with systemic ketoconazole, abiraterone acetate (AA) or any other cytochrome P450 17A1 (CYP17) inhibitor. Participant who has received systemic ketoconazole, AA or any other CYP17 inhibitor must have discontinued these agents ≥ 4 weeks prior to the first dose of study intervention.\n* Participant received prior systemic treatment with a strong inducer or inhibitor of cytochrome p450 3A4 (CYP3A4) within 4 weeks of first dose of study intervention. Concomitant use of strong inducers or inhibitors of CYP3A4 are not permitted on study.\n* Participant requires use of biotin (i.e., vitamin B7) or supplements containing biotin higher than the daily adequate intake of 30 μg. Note: Participant who switches from a high dose to a dose of 30 μg\u002Fday or less prior to first dose of study drug is eligible for study entry.\n* Participant is required to use any prohibited medication on the List of Excluded Concomitant Medications.\n* For mCRPC participants only: Participant has been treated with any of the following for prostate cancer, during the indicated time frame prior to enrollment:\n\n  * Hormonal therapy (e.g., androgen receptor blockers \\[AR\\] antagonists, second-generation androgen receptor pathway inhibitors \\[including enzalutamide, apalutamide, darolutamide, rezvilutamide and AA\\], 5-alpha reductase inhibitors, estrogens, cyproterone acetate) within 4 weeks of C1D1. Note: Participant has been treated with bicalutamide within 6 weeks prior to enrollment is not permitted. Participant has been treated with all other GnRH analogues or antagonists is permitted.\n  * Chemotherapy within 2 weeks or 5 half-lives of C1D1 (whichever is longer)\n  * Biologic therapy within 4 weeks of C1D1\n  * Immunotherapy within 4 weeks of C1D1\n  * Radiation therapy (includes radioligands) within 4 weeks of C1D1\n* For mHSPC participants only: Participant has received any prior pharmacotherapy, radiation therapy or surgery for metastatic prostate cancer (the following exceptions are permitted):\n\n  * Up to 4 months of ADT with GnRH agonists or antagonists or orchiectomy (within 3 months prior to C1D1) with or without concurrent antiandrogens.\n  * Participant may have 1 course of palliative radiation or surgical therapy to treat symptoms resulting from metastatic disease if it was administered at least 4 weeks prior to C1D1.\n  * Up to 6 cycles of docetaxel therapy, with the last dose of docetaxel ≤ 2 months prior to C1D1. A participant who has received docetaxel should have maintained a response to docetaxel of stable disease or better, by imaging and PSA, prior to C1D1.\n  * Up to 6 months of ADT with GnRH agonists or antagonists or orchiectomy with or without concurrent antiandrogens prior to C1D1 if subject was treated with docetaxel, with no radiographic evidence of disease progression or rising PSA levels prior to C1D1.\n* Participant has received any investigational therapy within 4 weeks or 5 half-lives (whichever is longer) prior to C1D1.\n* Participant has received ASP5541 previously.\n* Participant has absolute neutrophil count \\\u003C 1500\u002FμL, platelet count \\\u003C 100000\u002FμL or hemoglobin \\\u003C 9 g\u002FdL (6.2 mmol\u002FL) or international normalized ratio (INR) ≥ 1.5 (unless participant is taking oral anticoagulants in which case INR ≤ 2.0 is permitted) at Screening. Note: Participant may not have received any growth factors within 7 days or blood transfusions within 28 days prior to the hematology values obtained at Screening.\n* Participant has serum total bilirubin \\> 1.5 x upper limit of normal (ULN) (except participants with documented Gilbert's disease), or serum alanine aminotransferase or aspartate aminotransferase \\> 2.5 x ULN at Screening.\n* Participant does not have adequate renal function defined as a calculated creatinine clearance \\\u003C 30 mL\u002Fmin as determined by a validated algorithm for calculating creatinine clearance.\n* Participant has serum albumin \\\u003C 3.0 g\u002FdL (30 g\u002FL) at Screening.\n* Participant has a known or suspected hypersensitivity to ASP5541, prednisone, or any components of the formulations used.\n* Participant has a gastrointestinal disorder affecting absorption.","85 Years",{"count":228,"type":20},12,[137],"In this study, ASP5541 will be given to Chinese men with prostate cancer. It will be given together with prednisone and androgen deprivation therapy (ADT). Prednisone is a steroid, and ADT is already given to the men as their standard of care for prostate cancer.\n\nThe main aims of the study are to check the safety of ASP5541, when given with prednisone and ADT, and to check how ASP5541 moves through the bodies of Chinese men.\n\nThe men will receive ASP5541 as an injection into a muscle (intramuscular injection) at the side of the hip. They will all receive the same dose of ASP5541. The men will be given prednisone and ADT according to their label.\n\nThe men will continue to receive ASP5541 with prednisone and ADT until their cancer gets worse or the doctor decides the men should stop study treatment.",[55,161,162],[164,165,233],"Pharmacokinetics","2026-02-16",{"date":209,"type":30},{"date":237,"type":30},"2026-01-20",{"date":239,"type":20},"2028-12-31",{"name":174,"class":37},{"id":242,"slug":243,"hasResults":11,"nctId":244,"briefTitle":245,"officialTitle":246,"acronym":4,"eligibilityCriteria":247,"healthyVolunteers":11,"sex":16,"minAge":46,"maxAge":4,"enrollmentInfo":248,"targetDuration":250,"studyType":21,"phases":4,"briefSummary":251,"conditions":252,"keywords":4,"overallStatus":254,"whyStopped":4,"lastUpdateSubmitDate":255,"lastUpdatePostDateStruct":256,"startDateStruct":258,"completionDateStruct":260,"leadSponsor":262,"locationsCount":4},"100595346","evaluation-of-the-efficacy-of-darolutamide-triplet-therapy-in-patients-with-metastatic-hormone-sensitive-prostate-cancer-100595346","NCT07031258","Evaluation of the Efficacy of Darolutamide Triplet Therapy in Patients With Metastatic Hormone-sensitive Prostate Cancer","Prospective Real-world Data Evaluation of Darolutamide (DARO) in Combination With Androgen-deprivation Therapy (ADT) and Docetaxel (DOC) in Patients With Metastatic Hormone-sensitive Prostate Cancer","Inclusion Criteria:\n\nVoluntarily signed informed consent form and able to understand and agree to comply with study requirements; Age ≥18； Male； Patients diagnosed with metastatic hormone-sensitive prostate cancer via CSCO guidelines, histopathology, etc.； Patients determined by treating physician to require darolutamide triplet therapy ECOG performance status score of 0-1 as evaluated by the Eastern Cooperative Oncology Group (ECOG) criteria； Life expectancy of over 1 year； Good compliance with regular serum PSA testing during treatment；\n\nExclusion Criteria:\n\nPresence of other malignancies within the past 2 years or currently; Severe cardiovascular\u002Fcerebrovascular disease within 6 months prior to study treatment initiation, including: severe\u002Funstable angina, myocardial infarction, congestive heart failure \\[NYHA Class III or worse\\], stroke, or arrhythmia requiring medication; Allergy to any study drug or excipient; Inability to swallow, chronic diarrhea, intestinal obstruction, or other factors affecting drug intake\u002Fabsorption; Underlying medical condition\u002Falcohol or drug abuse\u002Fdependence that may interfere with drug administration, result in adverse events, or complicate outcome interpretation; Participation in another therapeutic clinical study; Deemed unsuitable for the study by the investigator.",{"count":249,"type":20},50,"1 Year","The purpose of this study is to investigate the clinical efficacy and safety of darolutamide combined with androgen deprivation therapy (ADT) and different dose-intensity docetaxel chemotherapy in the treatment of patients with metastatic hormone-sensitive prostate cancer.",[25,253],"Darolutamide (DARO) in Combination With Androgen-deprivation Therapy (ADT) and Docetaxel (DOC)","NOT_YET_RECRUITING","2025-06-12",{"date":257,"type":30},"2025-06-22",{"date":259,"type":20},"2025-06",{"date":261,"type":20},"2027-06",{"name":263,"class":68},"Nanfang Hospital, Southern Medical University"]