CTIS2023-505830-89-00进行中（未招募）1 期
(20510) A Phase 4, randomized, open-label, multicenter efficacy and safety study of standard dose of radium-223 dichloride vs. standard doses of novel anti-hormonal therapy (NAH) in patients with bone dominant metastatic castration resistant prostate cancer (mCRPC) progressing on/after one line of NAH - 20510
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 806
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 年龄范围
- 18 至 65+（—）
- 性别
- Male
入选标准
- •Participant must be =18 years of age inclusive, at the time of signing the informed consent. The lower limit may be higher if legally required in the participating country., Eastern Cooperative Oncology Group performance status (ECOG PS) 0 or 1., Life expectancy = 6 months., Able to swallow abiraterone and prednisone / prednisolone or enzalutamide as whole tablets/capsules., Laboratory requirements: a. Absolute neutrophil count (ANC) = 1.5 x 10^9/L b. Platelet count = 100 x 10^9/L c. Hemoglobin (Hb) = 9.0 g/dL (90 g/L; 5.6 mmol/L) d. Total bilirubin level = 1.5 x institutional upper limit of normal (ULN) (except for participants with documented Gilbert's disease) e. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) = 2.5 x ULN f. Creatinine = 1.5 x ULN or estimated glomerular filtration rate (eGFR) = 30 mL/min/1.73 m^2 as calculated using the Cockcroft-Gault equation g. International normalized ratio (INR) of prothrombin time (PT; PTINR) and partial thromboplastin time (PTT) = 1.5 times the ULN. Participants treated with warfarin or heparin will be allowed to participate in the study if no underlying abnormality in coagulation parameters exists per prior history; weekly evaluation of PT-INR / PTT will be required until stability is achieved (as defined by local standard of care and based on pre-study PT-INR / PTT values) h. Serum albumin > 30 g/L I. Serum potassium = 3.5 mmol/L., Male. Contraceptive use by men or women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. a. Male participants who have partners of childbearing potential (or whose partner is pregnant at study start) must use a condom during intercourse or sexual activity while receiving treatment and for 6 months following completion of treatment with radium-223 dichloride, 13 weeks after the last administration of abiraterone and 3 months after the last administration of enzalutamide. The contraception measures must be discussed with the participant. For a non-pregnant partner of childbearing potential, additional contraception recommendations should also be considered. Suitable contraception could be, for example, the use of an oral contraceptive by the partner. Note: Conservation of sperm: There are no human data on the effect of radium-223 dichloride on fertility; however, based on studies in animals, there is a potential risk that radiation from radium-223 dichloride could cause adverse effects on fertility. Participants should seek advice on conservation of sperm prior to treatment. b. Female participants: not applicable, Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol, Participants who have histologically confirmed adenocarcinoma of the prostate., Participants with mCRPC progressing on/after one line of an approved NAH (eg. abiraterone, enzalutamide, apalutamide, or darolutamide, after being treated for at least 3 months) in an authorized prostate cancer indication., One prior taxane treatment regimen (at least 2 cycles) for metastatic prostate cancer (mHSPC and mCRPC) or refusal or ineligibility of such a regimen., Prostate cancer progression documented by PSA according to the Prostate Cancer Working Group 3 (PCWG3) criteria or radiological progression according to RECIST, version 1.1., At least 2 bone metastases on bone scan within 4 weeks
排除标准
- •Active infection or other medical condition that would make prednisone / prednisolone (corticosteroid) use contraindicated., Uncontrolled hypertension (systolic blood pressure = 160 mmHg or diastolic blood pressure = 95 mmHg). Participants with a history of hypertension are allowed provided blood pressure is controlled by antihypertensive treatment., Active or symptomatic viral hepatitis., History of pituitary or adrenal dysfunction., Any other serious illness or medical condition such as, but not limited to: a. Any infection = National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0 Grade 2. b. Clinically significant heart disease as evidenced by myocardial infarction, or arterial thrombotic events in the past 6 months, severe orunstable angina, or New York Heart Association (NYHA) Class II to IV heart disease or cardiac ejection fraction measurement of <50% at baseline. c. Current clinical evidence of any uncontrolled cardiac arrhythmia. d. Crohn's disease or ulcerative colitis. e. Bone marrow dysplasia. f. Moderate and severe hepatic impairment (Child-Pugh Classes B and C). g. Unmanageable fecal incontinence., Any condition, which in the opinion of the investigator would preclude participation in this trial (eg, history of seizure)., Hypersensitivity to the active substances or to any excipients of radium-223 dichloride, or abiraterone acetate or enzalutamide., Prior therapeutic systemic radiation with any radiopharmaceutical medication for the treatment of prostate cancer, including but o tlimited to lutetium-177, strontium-89, samarium-153, iodine-131, rhenium-186, rhenium-188, or radium-223. Radiopharmaceutical compounds used for diagnosis purposes only are allowed., Prior hemibody external radiotherapy is excluded. Participants who received other types of prior external radiotherapy are allowed provided that the bone marrow function is assessed and meets the protocol requirements for Hb, ANC, and platelet count., Blood transfusion or erythropoietin stimulating agents 4 weeks prior to Screening and during the whole Screening period before randomization., Excessive intake of biotin above the recommended daily dose of 30 µg. Biotin is found in multivitamins, including prenatal multivitamins, biotin supplements, and dietary supplements for hair, skin, and nail growth at levels that may interfere with laboratory tests., Any chronic medical condition requiring a higher dose of corticosteroid than 10 mg prednisone / prednisolone equivalent daily for more than 2 months., Prior administration of an investigational therapeutic for CRPC., Previous (within the last 4 weeks of randomization) or concurrent participation in any interventional clinical study with investigationa lstudy drug administration., Pathological finding consistent with tumors with predominant neuroendocrine features or small cell carcinoma of the prostate (ie. tumors documented as having a small cell carcinoma histology and those having predominant neuroendocrine features [if mixed histology])., History of osteoporotic fracture., History of visceral metastasis, or presence of visceral metastasis detected by screening imaging examinations., History of or known brain metastasis., Malignant lymphadenopathy exceeding 3 cm in short-axis diameter., Other malignancy treated within the last 3 years (except nonmelanoma skin cancer or low-grade superficial bladder cancer), Imminent spinal cord compression based on clinical findings and /
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