NCT05679193CompletedPhase 2
Perioperative Propranolol During Prostatectomy to Decrease Cancer Recurrence
Perioperative Propranolol in Robotic Assisted Laparoscopic Prostatectomy- A Feasibility Study of Propranolol to Target Perioperative Stress Induced Cancer Progression
Source: ClinicalTrials.gov · Last updated 29 May 2024
Brief summary (registry, in English)
The purpose of this study is to assess the feasibility of conducting a larger randomized controlled trial to assess the efficacy of perioperative propranolol capsules compared with placebo capsules in decreasing recurrence of prostate cancer (PCa) after robotic assisted laparoscopic prostatectomy (RALP) in participants with intermediate to high-risk for prostate cancer recurrence.
- Status (registry)
- Completed
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 40 (actual)
- First submitted
- 12 Dec 2022
- Start date
- 2 Jan 2023
- Primary completion date
- 28 Nov 2023
- Lead sponsor
- Oslo University Hospital
- Diseases
- Prostate cancer
- NCT number
- NCT05679193
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 40
- From 2 Jan 2023 to the primary completion date, 28 Nov 2023
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Participants with known substance- or alcohol-abuse
- Prior/Concomitant Therapy
- Recent (\<3 month) use of systemic beta-blockers prior to screening.
- Patients receiving anti-arrhythmic agents (e.g. amiodarone, sotalol, digoxin, verapamil, flecainide)
- Patients receiving digoxin, rizatriptan, hydralazine, fluvoksamin, or fluoksetin
- Recommendations in the Summary of Product Characteristics for propranolol regarding concomitant use of other medications will be adhered to.
- Diagnostic assessments
Other illness
- Medical Conditions
- Sick sinus syndrome
- Recent (3 months) myocardial infarction
- Known unstable- or vasospastic- angina
- Heart failure (New York Heart Association \[NYHA\] \> 2)
- Symptomatic peripheral vascular disease (e.g. intermittent claudication)
- Known pulmonary hypertension
- Known carotid artery stenosis or recent (3 months) stroke
- Bronchial asthma or other chronic obstructive pulmonary disease (COPD)
- Liver failure (cirrhosis, jaundice, signs of hepatic decompression)
- Unregulated diabetes mellitus
- Untreated thyroid disorder
- Known drug allergy against propranolol or excipients
- Any medical conditions considered to prohibit Propranolol use as judged by the treating physician (including frailty).
- Resting blood pressure \<110/60mmHg OR hypertension BP \>160/100
Lab values
- Kidney failure (estimated Glomerular filtration rate \[eGFR\]\<50)
- Patients receiving non-dihydropyridine calcium channel blocking agents (eg diltiazem, verapamil)
Other
- Atrioventricular (AV) block grade 2 and 3
- Depressive episode within last 6 months (within last 12 months if major depressive episode)
- Patients using daily anxiolytics (e.g. benzodiazepines), alpha-receptor adrenergic agonists (e.g. clonidine)
- Sinus bradycardia (\<60 beats/minute)
- AV-block 2 or 3 on ECG
Who the study is looking for
- European Association of Urology Intermediate- and High Risk for Biochemical recurrence and planned for curative RALP
- ECOG Performance Status 0-1
Age in the registry: 40 years to 80 years · Sex: Male · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Oslo University Hospital-The Norwegian Radium Hospital Coordinator of this site? Confirm its status | Oslo | Norway | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.