EUCTR2015-005098-19-ES进行中（未招募）1 期
Phase IIIb randomized trial comparing irradiation plus long term adjuvant androgen deprivation with GnRH antagonist versus GnRH agonist plus flare protection in patients with very high risk localized or locally advanced prostate cancer. A joint study of the EORTC ROG and GUCG. Pegasus
European Organisation for Research and Treatment of Cancer (EORTC)0 个研究点目标入组 885 人开始时间: 2017年7月12日最近更新:
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
- 885
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
- •? Histologically confirmed diagnosis of prostate adenocarcinoma diagnosed on a systematic ultrasound guided biopsy of the prostate containing at least 8 cores. An MRI-fusion biopsy is allowed if taken because a previous biopsy was negative. A TURP specimen pathology is allowed. PSA = 10 ng/ml and two of the following 4 risk factors for relapse:
- •? PSA =20 ng/ml,
- •? Gleason sum =8,
- •? cN1 (regional LN with a short axis length >10mm by CT scan or MRI) or pathologically confirmed lymph nodes (pN1) (see Appendix H),
- •? cT3-T4 (by MRI or core biopsy)
- •(ie. If PSA=20 ng/ml then only one of the other 3 risk factors is needed)
- •? M0 by standard imaging work-up (see chapter 6 for specification of standard work-up)
- •? Testosterone = 200 ng/dl
- •? Adequate renal function: calculated creatinine clearance = 50 mL/min (Appendix D)
- •? Magnesium and potassium within normal limits of the institution or corrected to within normal limits prior to the first dose of treatment.
- •? Patients with prolonged QT-intervals due to prescribed Class IA (quinidine, procainamide) or Class III (amiodarone, sotalol) antiarrhythmic medication must be carefully evaluated for GnRH-agonist or GnRH antagonist use, because these drugs may prolong the QT-interval.
- •? Clinically normal cardiac function for-left ventricular ejection fraction (= 50%) as assessed either by multi-gated acquisition scan or cardiac ultrasound, triplicate 12 lead ECG without clinically relevant abnormalities. WHO Performance status 0-1 (see Appendix C)
- •? Age = 18 years and = 80 years
- •? Participants who have partners of childbearing potential must use adequate birth control measures, as defined by the investigator, during the study treatment period and for at least 3 months after last dose of study treatment. A highly effective method of birth control is defined as those which result in low failure rate (i.e. less than 1% per year) when used consistently and correctly
- •? Before patient registration/randomization, written informed consent must be given according to ICH/GCP, and national/local regulations.
- •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 295
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 590
排除标准
- •? Previous use of androgen deprivation therapy, antiandrogens. 5-alpha reductase inhibitors are allowed if interrupted for more than 6 months prior to entering the study
- •? History of severe untreated asthma, anaphylactic reactions or severe urticaria and/or angiodema.
- •? Hypersensitivity towards the investigational drug
- •? The following biological parameters :AST, ALT, total bilirubin, prothrombin time, serum albumin above upper level of normal range No severe hepatic impairment (Child Pugh C)
- •? History of gastro-intestinal disorders (medical disorders or extensive surgery) that may interfere with the absorption of the protocol treatment.
- •? History of pituitary or adrenal dysfunction
- •? Uncontrolled diabetes mellitus
- •? History of ulcerative colitis, Crohn's Disease, ataxia, telangiectasia, systemic lupus erythematosus, or Fanconi anemia.
- •? Clinically significant heart disease as evidence myocardial infarction, or arterial thrombotic events in the past 6 months, severe or unstable angina, or New York Heart Association (NYHA) class III or IV heart disease or cardiac ejection fraction measurement of < 50 % at baseline
- •? Coronary revascularization (PCI or multivessel CABG), carotid artery or iliofemoral artery revascularizaton (percutaneous or surgical procedure) within the last 30 days prior to entering the trial
- •? Certain risk factors for abnormal heart rhythms/QT prolongation: torsade de pointes ventricular arrhythmias (eg, heart failure, hypokalemia, or a family history of a long QT syndrome), a QT or corrected QT (QTc) interval >450 ms at baseline, or intake of medications that prolong the QT/QTc interval
- •? Uncontrolled hypertension (systolic BP = 160 mmHg or diastolic BP = 95 mmHg); patients with a history of hypertension are allowed provided blood pressure is controlled by anti-hypertensive treatment.
- •? Prior history of malignancies other than prostate adenocarcinoma (except patients with basal cell, squamous cell carcinoma of the skin), or the patient has been free of malignancy for a period of 3 years prior to first dose of study drug(s). Prior history of bladder cancer excludes the patient
- •? Prior radical prostatectomy (TURP or suprapubic adenomectomy for benign prostatic hyperplasia is allowed)
- •? Any contraindication to external beam radiotherapy
- •? Patients with significantly altered mental status prohibiting the understanding of the study or with psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule or any condition which, in the opinion of the investigator, would preclude participation in this trial.
研究者
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