Clinical Trials /

Propranolol Hydrochloride in Treating Patients With Prostate Cancer Undergoing Surgery

NCT03152786

Description:

This randomized pilot clinical trial studies how well propranolol hydrochloride works in treating patients with prostate cancer who are undergoing surgery. When stressed, the body makes a molecule that may prevent tumor cells from dying, and propranolol hydrochloride may affect the signals in cells that cause tumor cells survival and death.

Related Conditions:
  • Prostate Carcinoma
Recruiting Status:

Recruiting

Phase:

Phase 2

Trial Eligibility

Document

Title

  • Brief Title: Propranolol Hydrochloride in Treating Patients With Prostate Cancer Undergoing Surgery
  • Official Title: Evaluating the Effect of ADRB2 Blockers on PKA/BAD/CREB Signaling in Patients Undergoing Prostatectomy

Clinical Trial IDs

  • ORG STUDY ID: IRB00043227
  • SECONDARY ID: NCI-2017-00788
  • SECONDARY ID: CCCWFU 85716
  • SECONDARY ID: P30CA012197
  • NCT ID: NCT03152786

Conditions

  • Prostate Carcinoma

Interventions

DrugSynonymsArms
Propranolol HydrochlorideInderal, Innopran XLGroup I (propranolol hydrochloride)

Purpose

This randomized pilot clinical trial studies how well propranolol hydrochloride works in treating patients with prostate cancer who are undergoing surgery. When stressed, the body makes a molecule that may prevent tumor cells from dying, and propranolol hydrochloride may affect the signals in cells that cause tumor cells survival and death.

Detailed Description

      PRIMARY OBJECTIVES:

      I. To compare activation of ADRB2/PKA/BAD signaling pathway in the prostate glands of men two
      hours after taking or not taking propranolol hydrochloride (propranolol) prior to
      prostatectomy, as indicated by phosphorylated CREB.

      SECONDARY OBJECTIVES:

      I. To compare activation of ADRB2/PKA/BAD signaling pathway in the prostate glands of men two
      hours after taking or not taking propranolol prior to prostatectomy as indicated by
      phosphorylated BAD.

      II. To determine the difference in candidate transcript levels associated with ADRB2/PKA
      activation between individuals two hours after taking propranolol or not taking propranolol
      prior to prostatectomy.

      III. To determine plasma propranolol levels in individuals taking propranolol two hours after
      administration prior to prostatectomy.

      IV. To determine if plasma catecholamine levels in men with prostate cancer can be used as a
      biomarker to identify patients who show activation of ADRB2 signaling pathway in prostate
      tumors.

      V. To determine perceived stress level differences in men with prostate cancer prior to
      surgery to examine possible association between perceived stress level and catecholamine
      levels in blood and activation of ADRB2 pathway in tumors.

      VI. To determine perceived distress level differences in men with prostate cancer prior to
      surgery to examine possible association between distress level and catecholamine levels in
      blood and activation of ADRB2 pathway tumors.

      OUTLINE: Patients are randomized into 1 of 2 groups.

      GROUP I: Patients receive propranolol hydrochloride orally (PO) 2 hours prior to standard of
      care prostatectomy.

      GROUP II: Patients receive no treatment prior to standard of care prostatectomy.

      After completion of study treatment, patients are followed up for 30 days.
    

Trial Arms

NameTypeDescriptionInterventions
Group I (propranolol hydrochloride)ExperimentalPatients receive propranolol hydrochloride PO 2 hours prior to standard of care prostatectomy.
  • Propranolol Hydrochloride
Group II (no treatment)Active ComparatorPatients receive no treatment prior to standard of care prostatectomy.

    Eligibility Criteria

            Inclusion Criteria:
    
              -  Diagnosis of prostate cancer undergoing prostatectomy
    
              -  Individuals able to understand and willing to sign an Institutional Review Board
                 (IRB)-approved informed consent document
    
            Exclusion Criteria:
    
              -  Men taking propranolol on a daily for any reason are excluded
    
              -  Men with baseline systolic blood pressure (SBP) < 110 or heart rate (HR) < 60
    
              -  Men unable to swallow pills
    
              -  History of current or past medical or psychiatric illness that would make
                 participation difficult or not feasible at the discretion of the principal
                 investigator or co-investigators
          
    Maximum Eligible Age:N/A
    Minimum Eligible Age:19 Years
    Eligible Gender:Male
    Healthy Volunteers:No

    Primary Outcome Measures

    Measure:CREB phosphorylation
    Time Frame:2 hours after taking or not taking propranolol prior to prostatectomy
    Safety Issue:
    Description:Will be determined by western blot in prostate tissue from men.

    Secondary Outcome Measures

    Measure:BAD phosphorylation
    Time Frame:2 hours after taking or not taking propranolol prior to prostatectomy
    Safety Issue:
    Description:Will be assessed by western blot in prostate tissue from men. 2-sample t-tests will be calculated to compare the groups who were randomized to receive propranolol (yes/no). Descriptive statistics will be calculated for each measure within each group. These statistics include n, mean, standard deviations and 95% confidence intervals.
    Measure:Distress score
    Time Frame:On the day of surgery before taking propranolol, prior to prostatectomy
    Safety Issue:
    Description:Will be measured by The Distress Thermometer from men. 2-sample t-tests will be calculated to compare the groups who were randomized to receive propranolol (yes/no). Descriptive statistics will be calculated for each measure within each group. These statistics include n, mean, standard deviations and 95% confidence intervals.
    Measure:Levels of transcripts that reflect ADRB2/PKA activation
    Time Frame:2 hours after taking or not taking propranolol prior to prostatectomy
    Safety Issue:
    Description:Difference in levels of transcripts that reflect ADRB2/PKA activation will be measured by real-time polymerase chain reaction in prostate tissue from men. 2-sample t-tests will be calculated to compare the groups who were randomized to receive propranolol (yes/no). Descriptive statistics will be calculated for each measure within each group. These statistics include n, mean, standard deviations and 95% confidence intervals.
    Measure:Plasma catecholamine levels (including epinephrine)
    Time Frame:2 hours after taking or not taking propranolol prior to prostatectomy
    Safety Issue:
    Description:Will be measured by enzyme-linked immunosorbent assay from men. 2-sample t-tests will be calculated to compare the groups who were randomized to receive propranolol (yes/no). Descriptive statistics will be calculated for each measure within each group. These statistics include n, mean, standard deviations and 95% confidence intervals.
    Measure:Plasma propranolol levels
    Time Frame:2 hours after taking or not taking propranolol prior to prostatectomy
    Safety Issue:
    Description:Will be measured by fluorometric detection from men. 2-sample t-tests will be calculated to compare the groups who were randomized to receive propranolol (yes/no). Descriptive statistics will be calculated for each measure within each group. These statistics include n, mean, standard deviations and 95% confidence intervals.
    Measure:Self-perceived stress
    Time Frame:On the day of surgery before taking propranolol, prior to prostatectomy
    Safety Issue:
    Description:Will be measured by The Perceived Stress Questionnaire from men. 2-sample t-tests will be calculated to compare the groups who were randomized to receive propranolol (yes/no). Descriptive statistics will be calculated for each measure within each group. These statistics include n, mean, standard deviations and 95% confidence intervals.

    Details

    Phase:Phase 2
    Primary Purpose:Interventional
    Overall Status:Recruiting
    Lead Sponsor:Wake Forest University Health Sciences

    Last Updated

    June 3, 2020