EUCTR2013-004850-97-IE进行中（未招募）1 期
A Phase II Study of Radium-223 in Combination with Enzalutamide in Progressive Metastatic Castrate-Resistant Prostate Cancer - Radium-223 & Enzalutamide in mCRPC
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 44
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
- 性别
- Male
入选标准
- •Inclusion Criteria:
- •1. Written informed consent obtained prior to any study-related procedures
- •2. Age = 18 years and male.
- •3. ECOG performance status = 2.
- •4. Histologically/cytologically confirmed adenocarcinoma of the prostate, and without neuroendocrine differentiation or small cell histology.
- •5. Metastatic disease as confirmed by CT/MRI or bone scan
- •6. Patients must have documented Progressive disease (PD) either by radiological or PSA criteria as defined in a) and b) below:
- •a) For the radiological PD assessment, 2 sets of scans using the same imaging modality (ie CT/MRI or bone scan) and taken at separate time points are required to document radiological disease progression during or following the patient’s most recent anti-neoplastic therapy, (note: the 1st bone scan can be from before most recent therapy but the 2nd scan must show disease progression during or after the most recent therapy).
- •For patients with bone disease, progression will be assessed following recommendations by the Prostate Cancer Working Group (PCWG2): appearance of 2 or more new lesions on bone scan, confirmed, if necessary, by other imaging modalities (such as CT scan or MRI), if results of the bone scans are ambiguous).
- •For patients with soft tissue lesions progression will be assessed using RECIST 1.1 criteria. Patients may have measurable or non-measurable disease according to RECIST criteria version 1.1.
- •b) PSA progression is defined as an increase in PSA, as determined by 2 separate measurements taken at least 1 week apart and confirmed by a third. If the third measurement is not greater than the second measurement, then a fourth measurement must be taken and must be greater than the second measurement for the patient to be eligible for the study. Furthermore, the confirmatory PSA measurement (i.e. the third or, if applicable, fourth PSA measurement) must be defined. If a patient has received prior anti-androgen therapy (e.g. bicalutamide), PSA progression must be evident and documented after discontinuation of anti-androgen therapy, (note: The 1st PSA reading taken to document disease progression when the patient presents can be while the patient is on Casodex or other ADT).
- •7. Prior surgical castration or concurrent use of an agent for medical castration (e.g. GnRH analogue) with testosterone at screening less than 50ng/dL.
- •8. Screening PSA = 2ng/mL.
- •9. Patients, even if surgically sterilized (i.e. status post-vasectomy), who:
- •- will abstain from intercourse
- •- or must agree to use barrier contraception during and for 6 months after discontinuation of study treatment.
- •- If the patient engages in sexual intercourse with a woman of childbearing potential, a condom and another form of birth control must be used during and for 6 months after treatment.
- •10. Stable medical condition, including the absence of acute exacerbations of chronic illnesses, serious infections, or major surgery within 28 days prior to registration.
- •11. Life expectancy of 12 months or more based on general health and prostate cancer disease status as judged by the investigator.
- •12. Documented presence of osseous metastases with or without visceral involvement / lymph nodes.
- •13. Able to swallow study drug as whole tablet.
- •14. Adequate haematological, hepatic, and renal function.
- •Haemoglobin = 10g/dL.
- •Neutrophils (ANC/AGC) =1500/mm³ (1.5 x 10^9/L).
- •Platelets = (100 x 10^9/L).
- •Total bilirubin = 1.5mg/dL
排除标准
- •1. Patients receiving any other investigational agents (within 30 days prior to registration).
- •2. Patients with GI tract disease resulting in an inability to take oral medication, malabsorption syndrome, a requirement for IV alimentation, prior surgical procedures affecting absorption, uncontrolled inflammatory GI disease (e.g., Crohn’s disease, ulcerative colitis).
- •3. Have current active hepatic or biliary disease (with exception of patients with Gilbert's syndrome, asymptomatic gallstones, or stable chronic liver disease per investigator assessment).
- •4. Prior therapy with orteronel, ketoconazole, aminoglutethimide, abiraterone or enzalutamide.
- •5. All anti-androgen therapy (including bicalutamide) is excluded within 6 weeks prior to first dose of study drug. Any other therapies for prostate cancer, other than GnRH analogue therapy, such as progesterone, medroxyprogesterone, progestins (megesterol), or 5-alpha reductase inhibitors (eg, finasteride or dutasteride), must be discontinued 2 weeks before the first dose of study drug. [bisphosphonates and Denosumab are allowed concomitant medications].
- •6. Prior chemotherapy for prostate cancer, with the exception of:
- •- neoadjuvant/ adjuvant therapy as part of initial primary treatment for local disease that was completed 2 or more years prior to screening.
- •-Patients who received prior docetaxol for castrate sensitive metastatic prostate cancer commencing within 120 days of ADT initiation where total dose received did not exceed 450mg/m2
- •7. Prior exposure to radioisotope therapy; Prior exposure to bone directed radioisotope therapy, eg samarium 153, strontium 90.
- •8. Exposure to external beam radiation within 4 weeks prior to receiving the first dose of study drug. Patients must also have recovered from all treatment-related toxicities.
- •In patients with untreated imminent or established spinal cord compression, treatment with standard of care, as clinically indicated, should be completed before starting treatment with Ra-223 dichloride (Xofigo®).
- •9. Diagnosis of or treatment for another systemic malignancy within 2 years before the first dose of study drug, or previously diagnosed with another malignancy and have any evidence of residual disease. Patients with non-melanoma skin cancer or carcinoma? in situ of any type are not excluded if they have undergone complete resection.
- •10.History of myocardial infarction, unstable symptomatic ischemic heart disease/ unstable angina, uncontrolled on-going arrhythmias of Grade >2 (National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 4), pulmonary embolism, or any other cardiac condition (e.g. pericardial effusion restrictive cardiomyopathy) within 6 months prior to first dose of study drug. Patients with long QT, QTcF >470ms or uncontrolled hypertension are excluded.
- •11.New York Heart Association Class III or IV heart failure (see Appendix L).
- •12.History of seizure, underlying brain injury with loss of consciousness, stroke, Transient Ischaemic attack (TIA), cerebral vascular accident , primary brain tumours or brain metastases, brain arteriovenous malformation, alcoholism, or the use of concomitant medications that may lower the seizure threshold.
- •13. Known human immunodeficiency virus (HIV) infection, active chronic hepatitis B or C, life-threatening illness unrelated to cancer, or any ongoing serious medical or psychiatric illness that could, in the investigator
研究者
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