EUCTR2022-001184-28-NO进行中（未招募）1 期
Perioperative Propranolol in Robotic Assisted Laparoscopic Prostatectomy - A Pilot StudyA parallel-group, phase 2, double-blind, 2-arm study to assess the feasibility of conducting a formal larger randomized controlled trial that compare perioperative treatment with propranolol capsules compared with placebo capsules to target perioperative stress induced cancer progression after robotic assisted laparoscopic prostatectomy in participants with European Association of Urology intermediate- and high-risk prostate cancer, aged 40 to 80 years. - PeP-RALP
Oslo University Hospital0 个研究点目标入组 40 人开始时间: 2022年6月14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
- 40
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- Male
入选标准
- •1.Participant must be 40 to 80 years of age inclusive, at the time of signing the informed consent.
- •2.Participants with prostate cancer stratified into European Association of Urology intermadiate-risk and high-risk for biochemical recurrence planned for curative robotic assisted laparoscopic prostatectomy
- •3.Participants who are in the ECOG PS 0-1 as determined by medical evaluation including medical history, physical examination, laboratory tests, electrocardiogram (ECG).
- •4.Willing to-, and capable of, giving signed informed consent in Norwegian which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.
- •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 20
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range 20
排除标准
- •Medical Conditions
- •1.Sick sinus syndrome
- •2.Atrioventricular (AV) block grade 2 and 3
- •3.Recent (3 months) myocardial infarction
- •4.Known unstable- or vasospastic- angina
- •5.Heart failure (New York Heart Association [NYHA] > 2)
- •6.Symptomatic peripheral vascular disease (e.g. intermittent claudication)
- •7.Known pulmonary hypertension
- •8.Known carotid artery stenosis or recent (3 months) stroke
- •9.Bronchial asthma or other chronic obstructive pulmonary disease (COPD)
- •10.Kidney failure (estimated Glomerular filtration rate [eGFR]<50)
- •11.Liver failure (cirrhosis, jaundice, signs of hepatic decompression)
- •12.Unregulated diabetes mellitus
- •13.Untreated thyroid disorder
- •14.Depressive episode within last 6 months (within last 12 months if major depressive episode)
- •15.Known drug allergy against propranolol or excipients
- •16.Any medical conditions considered to prohibit Propranolol use as judged by the treating physician (including frailty).
- •17.Participants with known substance- or alcohol-abuse
- •Prior/Concomitant Therapy
- •18.Recent (<3 month) use of systemic beta-blockers prior to screening.
- •19.Patients receiving non-dihydropyridine calcium channel blocking agents (eg diltiazem, verapamil)
- •20.Patients receiving anti-arrhythmic agents (e.g. amiodarone, sotalol, digoxin, verapamil, flecainide)
- •21.Patients receiving digoxin, rizatriptan, hydralazine, fluvoksamin, or fluoksetin
- •22.Patients using daily anxiolytics (e.g. benzodiazepines), alpha-receptor adrenergic agonists (e.g. clonidine)
- •Diagnostic assessments
- •23.Sinus bradycardia (<60 beats/minute)
- •24.Resting blood pressure <110/60mmHg OR hypertension BP >160/100
- •25.AV-block on ECG
研究者
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