Prostate Cancer
Conditions
Interventions
Trade Name: Propranolol
Pharmaceutical Form:
Pharmaceutical form of the placebo: Capsule
Route of administration of the placebo: Oral use
Sponsors
Oslo University Hospital
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
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]160/100 25. AV-block on ECG
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this pilot is to establish the recruitment- and infrastructure- feasibility of a double-blinded, placebo controlled RCT of perioperative propranolol in patients undergoing RALP. The results of this pilot study is to be the foundation for a formal larger RCT with the aim to assess efficacy of perioperative propranolol to reduce PCa recurrence and progression after RALP. Adverse effects (AEs) and serious adverse effects (SAEs) to the drug will be analyzed throughout the study. ;Secondary Objective: 1-Safety and tolerability of PeP-RALP intervention 2-Determine the effect of RALP on catecholamine levels 3-Determine the bioavailability of propranolol 4-Determine the effect of preoperative propranolol treatment on the serum level of PSA 5-To determine the effect of propranolol on post-operative biochemical failure 6-Surgical complications in PeP RALP patients 7-Intraoperative challenges ;Primary end point(s): Numbers needed to screen Compliance before RALP >80% Compliance after RALP > 80% ;Timepoint(s) of evaluation of this end point: to be evaluated at end of study | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1: Proportion of patients experiencing treatment related clinical significant hypotension and/or bradycardia. Adverse events of PeP-RALP medication. Proportion of patients tolerating daily dose of 80mg propranolol. 2: Changes in catecholamine levels in the perioperative period. 3: Serum levels of propranolol pre-operatively and at end of PeP-RALP medication. 4: Changes in PSA levels after 7-14 days of PeP-RALP medication. 5: Proportion of patients with serum PSA levels above 0.1 ng/ml at 6 weeks post-RALP. 6: Frequency and severity of surgical complications 7: Anesthesiological challenges. Surgical challenges. ;Timepoint(s) of evaluation of this end point: Adverse events are to be assessed continuously until follow up. All other end points are to be evaluated at end of study. | — |
Countries
Norway
Contacts
Public ContactShivanthe Sivanesan
Oslo University Hospital
Outcome results
None listed