Propranolol Hydrochloride in Treating Patients With Prostate Cancer Undergoing Surgery

Study Overview
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Brief Summary
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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
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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.

Official Title
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Evaluating the Effect of ADRB2 Blockers on PKA/BAD/CREB Signaling in Patients Undergoing Prostatectomy

Conditions
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Prostate Carcinoma

Intervention / Treatment
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* Other: Laboratory Biomarker Analysis
* Drug: Propranolol Hydrochloride
* Other: Questionnaire Administration
* Other: Survey Administration


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group I (propranolol hydrochloride)<br>Patients receive propranolol hydrochloride PO 2 hours prior to standard of care prostatectomy. | Other: Laboratory Biomarker Analysis<br>* Correlative studies<br>Drug: Propranolol Hydrochloride<br>* Given PO<br>* Other names: Innopran XL;Other: Questionnaire Administration<br>* Ancillary studies<br>Other: Survey Administration<br>* Ancillary studies<br>|
| Active Comparator: Group II (no treatment)<br>Patients receive no treatment prior to standard of care prostatectomy. | Other: Laboratory Biomarker Analysis<br>* Correlative studies<br>Other: Questionnaire Administration<br>* Ancillary studies<br>Other: Survey Administration<br>* Ancillary studies<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| BAD phosphorylation | 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 hours after taking or not taking propranolol prior to prostatectomy | 
| Distress score | 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. | On the day of surgery before taking propranolol, prior to prostatectomy | 
| Levels of transcripts that reflect ADRB2/PKA activation | 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. | 2 hours after taking or not taking propranolol prior to prostatectomy | 
| Plasma catecholamine levels (including epinephrine) | 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. | 2 hours after taking or not taking propranolol prior to prostatectomy | 
| Plasma propranolol levels | 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. | 2 hours after taking or not taking propranolol prior to prostatectomy | 
| Self-perceived stress | 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. | On the day of surgery before taking propranolol, prior to prostatectomy |