Clinical trial · Interventional
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
NCT05679193CI-TRIAL-00077555PeP-RALPcompletedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Propranolol | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Propranolol
- description
- Participants will receive Propranolol capsule for a period of 22-28 days, low dose (1 capsule/20mg propranolol twice daily) treatment the first- and last- three days of the treatment period. Higher dose (2 capsules/40mg propranolol twice daily) for the rest of the treatment period.
- interventionNames
- Drug: Propranolol
- type
- PLACEBO_COMPARATOR
- label
- Placebo
- description
- Participants will receive Propranolol capsule for a period of 22-28 days, low dose (1 capsule twice daily) treatment the first- and last- three days of the treatment period. Higher dose (2 capsules twice daily) for the rest of the treatment period.
- interventionNames
- Drug: Propranolol
Primary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 40 Years
- Maximum age
- 80 Years
Show eligibility criteria text
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 2 or 3 on ECGReferences
Publications (7)
- BACKGROUNDSivanesan S, Tasken KA, Grytli HH. Association of beta-Blocker Use at Time of Radical Prostatectomy With Rate of Treatment for Prostate Cancer Recurrence. JAMA Netw Open. 2022 Jan 4;5(1):e2145230. doi: 10.1001/jamanetworkopen.2021.45230. PMID 35080602
- BACKGROUNDZhou L, Li Y, Li X, Chen G, Liang H, Wu Y, Tong J, Ouyang W. Propranolol Attenuates Surgical Stress-Induced Elevation of the Regulatory T Cell Response in Patients Undergoing Radical Mastectomy. J Immunol. 2016 Apr 15;196(8):3460-9. doi: 10.4049/jimmunol.1501677. Epub 2016 Mar 11. PMID 26969754
- BACKGROUNDHiller JG, Cole SW, Crone EM, Byrne DJ, Shackleford DM, Pang JB, Henderson MA, Nightingale SS, Ho KM, Myles PS, Fox S, Riedel B, Sloan EK. Preoperative beta-Blockade with Propranolol Reduces Biomarkers of Metastasis in Breast Cancer: A Phase II Randomized Trial. Clin Cancer Res. 2020 Apr 15;26(8):1803-1811. doi: 10.1158/1078-0432.CCR-19-2641. Epub 2019 Nov 21. PMID 31754048
- BACKGROUNDShaashua L, Shabat-Simon M, Haldar R, Matzner P, Zmora O, Shabtai M, Sharon E, Allweis T, Barshack I, Hayman L, Arevalo J, Ma J, Horowitz M, Cole S, Ben-Eliyahu S. Perioperative COX-2 and beta-Adrenergic Blockade Improves Metastatic Biomarkers in Breast Cancer Patients in a Phase-II Randomized Trial. Clin Cancer Res. 2017 Aug 15;23(16):4651-4661. doi: 10.1158/1078-0432.CCR-17-0152. Epub 2017 May 10. PMID 28490464
- BACKGROUNDHaldar R, Shaashua L, Lavon H, Lyons YA, Zmora O, Sharon E, Birnbaum Y, Allweis T, Sood AK, Barshack I, Cole S, Ben-Eliyahu S. Perioperative inhibition of beta-adrenergic and COX2 signaling in a clinical trial in breast cancer patients improves tumor Ki-67 expression, serum cytokine levels, and PBMCs transcriptome. Brain Behav Immun. 2018 Oct;73:294-309. doi: 10.1016/j.bbi.2018.05.014. Epub 2018 May 22. PMID 29800703
- BACKGROUNDJang HI, Lim SH, Lee YY, Kim TJ, Choi CH, Lee JW, Kim BG, Bae DS. Perioperative administration of propranolol to women undergoing ovarian cancer surgery: A pilot study. Obstet Gynecol Sci. 2017 Mar;60(2):170-177. doi: 10.5468/ogs.2017.60.2.170. Epub 2017 Mar 16.