EUCTR2013-004711-50-BE进行中（未招募）1 期
A Randomized, Double-Blind, Placebo-Controlled, Phase IIIb Study of the Efficacy and Safety of Continuing Enzalutamide inChemotherapy Naïve Metastatic Castration Resistant Prostate Cancer Patients Treated with Docetaxel plus Prednisolone Who Have Progressed on Enzalutamide Alone - PRESIDE
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 650
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
- •1. Age 18 or older;
- •2. Independent Ethics Committee (IEC)-approved written Informed Consent and privacy language as per national regulations must be obtained from the subject or legally authorized representative prior to any study-related procedures (including withdrawal of prohibited medication, if applicable);
- •3. Histologically confirmed adenocarcinoma of the prostate without neuroendocrine differentiation or small cell features;
- •4. Ongoing ADT with a luteinizing hormone-releasing hormone (LHRH) agonist or antagonist at a stable dose and schedule within 4 weeks of initiation of IMP, or bilateral orchiectomy (i.e., surgical or medical castration);
- •5. Serum testosterone level ? 1.73 nmol/L (? 50 ng/dL);
- •6. Metastatic (M1) disease documented by at least 2 bone lesions on bone scan, or soft tissue disease documented by CT/MRI;
- •7. Progressive disease at study entry defined as the following occurring in the setting of castrate levels of testosterone: PSA progression defined by a minimum of three rising PSA levels with an interval of ? 1 week between each determination. The PSA value at Screening should be ? 2 ?g/L (? 2 ng/mL). In the event of prior androgen receptor inhibitor use, the most recent local PSA and the Screening PSA assessed by the central laboratory (central PSA) must be obtained at least 4 weeks after the last dose of androgen receptor inhibitor;
- •8. Asymptomatic or minimally symptomatic prostate cancer (BPI SF question 3 score of < 4) at Screening;
- •9. ECOG performance score of 0-1 at Screening;
- •10. Estimated life expectancy of ? 12 months from Screening;
- •11. Be suitable and willing to receive chemotherapy as part of the trial;
- •12. Able to swallow the IMP and comply with study requirements;
- •13. Subjects and their female spouse/partners who are of childbearing potential must be using highly effective contraception consisting of 2 forms of birth control* (one of which must be a condom) starting at Screening and continue throughout the study period and for 3 months after the final IMP administration;
- •14. Subjects must not donate sperm starting at Screening and throughout the study period and for 3 months after the final IMP administration. A condom is required throughout the study period and for 3 months after the final IMP administration if the subject is engaged in sexual activity with a pregnant woman;
- •15. Subject agrees not to participate in another interventional study while on treatment. Subjects who are participating in a control arm of an interventional study which includes only standard of care, or in an observational phase following an interventional study, may be eligible for this study, providing they meet all the other entry criteria
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 175
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 475
排除标准
- •1. Absolute neutrophil count (ANC) < 1,500/?L, platelet count < 100,000/?L, or hemoglobin < 6.2 mmol/L (< 10 g/dL)
- •(NOTE: subjects must not have received any growth factors or blood transfusions within seven days prior to the hematologic laboratory values obtained at Screening);
- •2. Total bilirubin > upper limit of normal (ULN); alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ? 2.5 times ULN; Child-Pugh B and C hepatic impairment;
- •3. Creatinine > 177 ?mol/L (> 2 mg/dL);
- •4. Albumin ? 30 g/L (? 3.0 g/dL;
- •5. Prior treatment with the following agents for the treatment of prostate cancer: Aminoglutethimide; Ketoconazole; Abiraterone; Enzalutamide or participation in a clinical trial of enzalutamide; 223Ra, 89Sr, 153Sm, 186Re/188Re; Immunomodulatory therapies (e.g. Sipuleucel-T, DCVAC); Cytotoxic chemotherapy (e.g. docetaxel, cabazitaxel, mitoxantrone, estramustine); Participation in a clinical trial of an investigational agent that inhibits the androgen receptor or androgen synthesis (e.g. ARN-509, ODM-201, VT-464; unless the treatment was placebo);
- •6. Current or prior treatment within 4 weeks prior to initiation of IMP with the following agents for the treatment of prostate cancer: Antiandrogens (e.g., bicalutamide, nilutamide, flutamide); 5-? reductase inhibitors (e.g., finasteride, dutasteride); Estrogens; Anabolic steroids; Drugs with antiandrogenic properties such as spironolactone > 50 mg/kg; Progestational agents;
- •7. Subject has received investigational therapy within 28 days or 5 half-lives, whichever is longer, prior to initiation of IMP;
- •8. Use of opiate analgesia for pain from prostate cancer within 4 weeks prior to initiation of IMP;
- •9. Radiation therapy to bone lesions or prostatic bed within 4 weeks prior to initiation of IMP;
- •10. Major surgery within 4 weeks prior to initiation of IMP;
- •11. History of seizure or any condition that may predispose to seizures at any time in the past (e.g., prior cortical stroke, brain arteriovenous malformation, head trauma with loss of consciousness requiring hospitalization). History of loss of consciousness or transient ischemic attack within 12 months prior to Screening;
- •12. Known or suspected brain metastasis or active leptomeningeal disease;
- •13. History of another malignancy within the previous 5 years other than non-melanoma skin cancer;
- •14. Clinically significant cardiovascular disease including: Myocardial infarction within six months prior to Screening; Uncontrolled angina within three months prior to Screening; Congestive heart failure New York Heart Association (NYHA) class 3 or 4, or subjects with history of congestive heart failure NYHA class 3 or 4 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%; History of clinically significant ventricular arrhythmias (e.g., ventricular tachycardia, ventricular fibrillation, torsades de pointes); History of Mobitz II second degree or third degree heart block without a permanent pacemaker in place; Bradycardia as indicated by a heart rate < 45 beats per minute on the screening ECG or physical examination; Uncontrolled hypertension as indicated by a resting systolic blood pressure > 170 mmHg or diastolic blood pressure > 105 mmHg at Screening;
- •15. Gastrointestinal disorders affecting absorption (e.g., extensive small bowel resection, active inflammatory bowel disease);
- •16. Medical contrain
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