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Propranolol Hydrochloride in Treating Patients With Prostate Cancer Undergoing Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03152786
Recruitment Status : Recruiting
First Posted : May 15, 2017
Last Update Posted : June 4, 2020
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Wake Forest University Health Sciences

Tracking Information
First Submitted Date  ICMJE May 9, 2017
First Posted Date  ICMJE May 15, 2017
Last Update Posted Date June 4, 2020
Actual Study Start Date  ICMJE January 15, 2019
Estimated Primary Completion Date February 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 11, 2017)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 11, 2017)
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Propranolol Hydrochloride in Treating Patients With Prostate Cancer Undergoing Surgery
Official Title  ICMJE Evaluating the Effect of ADRB2 Blockers on PKA/BAD/CREB Signaling in Patients Undergoing Prostatectomy
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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Prostate Carcinoma
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • Experimental: Group I (propranolol hydrochloride)
    Patients receive propranolol hydrochloride PO 2 hours prior to standard of care prostatectomy.
    Interventions:
    • Other: Laboratory Biomarker Analysis
    • Drug: Propranolol Hydrochloride
    • Other: Questionnaire Administration
    • Other: Survey Administration
  • Active Comparator: Group II (no treatment)
    Patients receive no treatment prior to standard of care prostatectomy.
    Interventions:
    • Other: Laboratory Biomarker Analysis
    • Other: Questionnaire Administration
    • Other: Survey Administration
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: May 11, 2017)
50
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE February 2021
Estimated Primary Completion Date February 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 19 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03152786
Other Study ID Numbers  ICMJE 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 )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Wake Forest University Health Sciences
Study Sponsor  ICMJE Wake Forest University Health Sciences
Collaborators  ICMJE National Cancer Institute (NCI)
Investigators  ICMJE
Principal Investigator: Ashok Hemal Wake Forest University Health Sciences
PRS Account Wake Forest University Health Sciences
Verification Date June 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP