PeP-RALP: A randomized, double-blind, placebo controlled feasibility study on perioperative use of propranolol during robotic assisted laparoscopic prostatectomy (RALP) in participants with intermediate to high-risk prostate cancer.
- Conditions
- Prostate CancerTherapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2022-001184-28-NO
- Lead Sponsor
- Oslo University Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Male
- Target Recruitment
- 40
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
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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method