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Recruiting NCT05679193

Perioperative Propranolol During Prostatectomy to Decrease Cancer Recurrence

Conditions: Prostate Cancer

Sex: Male
Ages: 40 Years – 80 Years
Healthy volunteers: 1
Phase: PHASE2
Enrollment: 40
Sponsor: Oslo University Hospital

Location: Norway

Summary

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 after robotic assisted laparoscopic prostatectomy (RALP) in participants with intermediate to high-risk for prostate cancer recurrence.

Eligibility Criteria

Inclusion Criteria:European Association of Urology Intermediate- and High Risk for Biochemical recurrence and planned for curative RALPECOG Performance Status 0-1Exclusion Criteria:Medical ConditionsSick sinus syndromeAtrioventricular (AV) block grade 2 and 3Recent (3 months) myocardial infarctionKnown unstable- or vasospastic- anginaHeart failure (New York Heart Association [NYHA] > 2)Symptomatic peripheral vascular disease (e.g. intermittent claudication)Known pulmonary hypertensionKnown carotid artery stenosis or recent (3 months) strokeBronchial asthma or other chronic obstructive pulmonary disease (COPD)Kidney failure (estimated Glomerular filtration rate [eGFR]<50)Liver failure (cirrhosis, jaundice, signs of hepatic decompression)Unregulated diabetes mellitusUntreated thyroid disorderDepressive episode within last 6 months (within last 12 months if major depressive episode)Known drug allergy against propranolol or excipientsAny medical conditions considered to prohibit Propranolol use as judged by the treating physician (including frailty).Participants with known substance- or alcohol-abusePrior/Concomitant TherapyRecent (<3 month) use of systemic beta-blockers prior to screening.Patients receiving non-dihydropyridine calcium channel blocking agents (eg diltiazem, verapamil)Patients receiving anti-arrhythmic agents (e.g. amiodarone, sotalol, digoxin, verapamil, flecainide)Patients receiving digoxin, rizatriptan, hydralazine, fluvoksamin, or fluoksetinPatients using daily anxiolytics (e.g. benzodiazepines), alpha-receptor adrenergic agonists (e.g. clonidine)Recommendations in the Summary of Product Characteristics for propranolol regarding concomitant use of other medications will be adhered to.Diagnostic assessmentsSinus bradycardia (<60 beats/minute)Resting blood pressure <110/60mmHg OR hypertension BP >160/100AV-block on ECG

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05679193). StuddyBuddy aggregates publicly available trial information.