Perioperative Propranolol During Prostatectomy to Decrease Cancer Recurrence

• Status: Not yet recruiting
• Trial end date: 2023-10-01
• Target enrollment: 0
• Participant gender: Male

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Oslo University Hospital
• Treatments: Propranolol

Criteria

Inclusion Criteria:

• European Association of Urology Intermediate- and High Risk for Biochemical recurrence and planned for curative RALP

• ECOG Performance Status 0-1

Exclusion Criteria:

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)

23. Recommendations in the Summary of Product Characteristics for propranolol regarding concomitant use of other medications will be adhered to.

Diagnostic assessments

24. Sinus bradycardia (<60 beats/minute)

25. Resting blood pressure <110/60mmHg OR hypertension BP >160/100

26. AV-block on ECG