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.
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
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
46
Correlative studies
Given PO
Ancillary studies
Comprehensive Cancer Center of Wake Forest University
Winston-Salem, North Carolina, United States
Mean Level of CREB Phosphorylation
Determined using western blot in prostate tissue from men. CREB is a type of protein that binds to DNA in very specific places. CREB is related to long-term memory formation in the brain and is important in the formation of spatial memory. Phosphorylation alters the structural conformation of a protein, causing it to become activated, deactivated, or otherwise modifying its function. The level of CREB phosphorylation is an indicator of BAD activity.
Time frame: 2 hours after taking or not taking propranolol prior to prostatectomy
BAD Phosphorylation
Will be assessed by western blot in prostate tissue from men. BAD is a protein that plays a critical role in cell survival. Phosphorylation alters the structural conformation of a protein, causing it to become activated, deactivated, or otherwise modifying its function. This analysis shows how much phosphorylation of BAD protein is happening in cells.
Time frame: 2 hours after taking or not taking propranolol prior to prostatectomy
Distress Score - National Comprehensive Cancer Network Distress Thermometer Questionnaire
Will be measured by The Distress Thermometer from men. The NCCN Distress Thermometer (DT) is a one-item, 11-point Likert scale represented on a visual graphic of a thermometer that ranges from 0 (no distress) to 10 (extreme distress), with which patients indicate their level of distress over the course of the week prior to assessment. Scoring scale ranges from 0 (no distress) to 10 (extreme distress) with higher scores indicating more distress.
Time frame: 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.
Time frame: 2 hours after taking or not taking propranolol prior to prostatectomy
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Ancillary studies
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.
Time frame: 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.
Time frame: 2 hours after taking or not taking propranolol prior to prostatectomy
Self-perceived Stress
Will be measured by The Perceived Stress Questionnaire from men. The perceived stress questionnaire is a set of 4 questions asking participants about their feelings/problems with stress over the last two weeks. Scoring scale ranges from 0 to 16 with higher scores indicating a higher level of stress.
Time frame: On the day of surgery before taking propranolol, prior to prostatectomy