EUCTR2016-002854-19-BE进行中（未招募）1 期
eoadjuvant degarelix +/- apalutamide (ARN-509) followed by radical prostatectomy for intermediate and high-risk prostate cancer: a randomized, placebo-controlled trial.
Z Leuven0 个研究点目标入组 102 人开始时间: 2017年5月11日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 102
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
- •Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial
- •2. Before patient registration/randomization, written informed consent must be attained according to ICH/GCP, and national/local regulations
- •3. Male aged 18 years or older (within 80 years)
- •4. Histologically confirmed adenocarcinoma of the prostate without neuroendocrine differentiation or small cell features
- •5. Diagnosis of intermediate prostate cancer (at least 2 of the following factors: cT2b, biopsy GS 7, PSA 10-20ng/ml) or high-risk prostatic
- •adenocarcinoma (clinical stage=T2c and/or biopsy GS=8 and/or PSA>20ng/ml), cN0-cN1, cM0.
- •6. Patient amenable for radical prostatectomy + pelvic lymph node dissection by open or robotic approach.
- •7. ECOG performance status: 0-1 (Appendix1)
- •8. Adequate organ function as defined by the following criteria:
- •- White blood cells (WBC) = 4.0 x109/L
- •- Platelet count = 100 x109/L
- •- Hemoglobin = 9.0 g/dl
- •- Creatinine = 2 x ULN
- •- Serum aspartate transaminase (AST; serum glutamic oxaloacetic transaminase [SGOT]) and serum alanine transaminase (ALT; serum glutamic pyruvic transaminase [SGPT]) = 2.5 x upper limit of normality (ULN)
- •- Total serum bilirubin =1.5 x ULN.
- •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 102
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 102
排除标准
- •Previous surgical/endoscopic treatments for prostatic disease
- •2. Food supplements or herbal products that in the opinion of the investigator may decrease PSA levels
- •3. cM1 disease
- •4. Any contraindication for PET or MR imaging
- •5. History of seizure or condition that may pre-dispose to seizure (e.g., prior stroke within 1 year prior to randomization, brain arteriovenous malformation, Schwannoma, meningioma, or other benign CNS or meningeal disease which may require treatment with surgery or radiation therapy)
- •6. Medications known to lower the seizure threshold (Appendix 2)
- •7. History of:
- •- Any prior malignancy (other than adequately treated basal cell or squamous cell skin cancer, superficial bladder cancer currently in complete remission) within 5 years prior to randomization
- •- Severe/unstable angina, myocardial infarction, symptomatic congestive heart failure, arterial or venous thromboembolic events (e.g., pulmonary embolism, cerebrovascular accident including transient ischemic attacks), or clinically significant
- •ventricular arrhythmias within 6 months prior to randomization
- •- Uncontrolled hypertension (systolic blood pressure =160 mmHg or diastolic BP =100 mmHg). Patients with a history of uncontrolled hypertension are allowed provided blood pressure is controlled by anti-hypertensive treatment.
- •- Gastrointestinal disorder affecting absorption
- •8. Any other condition that, in the opinion of the Investigator, would impair the patient’s ability to comply with study procedures.
研究者
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