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Propranolol Hydrochloride in Treating Patients With Prostate Cancer Undergoing Surgery

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ClinicalTrials.gov Identifier: NCT03152786
Recruitment Status : Recruiting
First Posted : May 15, 2017
Last Update Posted : December 19, 2020
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Wake Forest University Health Sciences

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Prostate Carcinoma Other: Laboratory Biomarker Analysis Drug: Propranolol Hydrochloride Other: Questionnaire Administration Other: Survey Administration Phase 2

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Evaluating the Effect of ADRB2 Blockers on PKA/BAD/CREB Signaling in Patients Undergoing Prostatectomy
Actual Study Start Date : January 15, 2019
Estimated Primary Completion Date : April 2021
Estimated Study Completion Date : April 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Arms and Interventions
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Arm Intervention/treatment
Experimental: Group I (propranolol hydrochloride)
Patients receive propranolol hydrochloride PO 2 hours prior to standard of care prostatectomy.
 Other: Laboratory Biomarker Analysis
Correlative studies

Drug: Propranolol Hydrochloride
Given PO
Other Names:
  • Inderal
  • Innopran XL

Other: Questionnaire Administration
Ancillary studies

Other: Survey Administration
Ancillary studies
Active Comparator: Group II (no treatment)
Patients receive no treatment prior to standard of care prostatectomy.
 Other: Laboratory Biomarker Analysis
Correlative studies

Other: Questionnaire Administration
Ancillary studies

Other: Survey Administration
Ancillary studies


Outcome Measures
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Primary Outcome Measures :
  1. CREB phosphorylation [ Time Frame: 2 hours after taking or not taking propranolol prior to prostatectomy ]
    Will be determined by western blot in prostate tissue from men.


Secondary Outcome Measures :
  1. BAD phosphorylation [ Time Frame: 2 hours after taking or not taking propranolol prior to prostatectomy ]
    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.

  2. Distress score [ Time Frame: On the day of surgery before taking propranolol, prior to prostatectomy ]
    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.

  3. Levels of transcripts that reflect ADRB2/PKA activation [ Time Frame: 2 hours after taking or not taking propranolol prior to prostatectomy ]
    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.

  4. Plasma catecholamine levels (including epinephrine) [ Time Frame: 2 hours after taking or not taking propranolol prior to prostatectomy ]
    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.

  5. Plasma propranolol levels [ Time Frame: 2 hours after taking or not taking propranolol prior to prostatectomy ]
    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.

  6. Self-perceived stress [ Time Frame: On the day of surgery before taking propranolol, prior to prostatectomy ]
    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.


Eligibility Criteria
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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03152786


Locations
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United States, North Carolina
Comprehensive Cancer Center of Wake Forest University Recruiting
Winston-Salem, North Carolina, United States, 27157
Contact: Ashok K. Hemal    336-716-5694    ahemal@wakehealth.edu   
Principal Investigator: Ashok K. Hemal         
Sponsors and Collaborators
Wake Forest University Health Sciences
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Ashok Hemal Wake Forest University Health Sciences
More Information
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Responsible Party: Wake Forest University Health Sciences
ClinicalTrials.gov Identifier: NCT03152786    
Other Study ID Numbers: IRB00043227
NCI-2017-00788 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
CCCWFU 85716 ( Other Identifier: Comprehensive Cancer Center of Wake Forest University )
P30CA012197 ( U.S. NIH Grant/Contract )
First Posted: May 15, 2017    Key Record Dates
Last Update Posted: December 19, 2020
Last Verified: December 2020

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Prostatic Diseases
Propranolol
Adrenergic beta-Antagonists
 Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Anti-Arrhythmia Agents
Antihypertensive Agents
Vasodilator Agents