A Phase 2 interventional study of Laboratory Biomarker Analysis and Propranolol Hydrochloride in Prostate Carcinoma, sponsored by Wake Forest University Health Sciences. Terminated at 1 site in United States. Open to male participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2026-08-03.
Sponsored by Wake Forest University Health Sciences · Phase 2, Interventional, and Treatment
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.
6,367 studies on the registry are indexed under Prostatic Neoplasms; 1,397 are open to participants now.
This study's enrollment of 46 is below the median of 58 across 4,821 interventional studies indexed under Prostatic Neoplasms.
Browse Prostatic Neoplasms studies →Wake Forest University Health Sciences is the lead sponsor of 1,320 studies on the registry; 199 are open to participants now.
Of its 323 completed or terminated interventional studies of FDA-regulated products, 243 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Patients receive propranolol hydrochloride PO 2 hours prior to standard of care prostatectomy.
Other: Laboratory Biomarker Analysis · Drug: Propranolol Hydrochloride · Other: Questionnaire Administration · Other: Survey Administration
Patients receive no treatment prior to standard of care prostatectomy.
Other: Laboratory Biomarker Analysis · Other: Questionnaire Administration · Other: Survey Administration
Correlative studies
Given PO
Also known as: Inderal, Innopran XL
Ancillary studies
Ancillary studies
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
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
January 15, 2019 to June 8, 2021
| Milestone | Group I (Propranolol Hydrochloride) | Group II (no Treatment) |
|---|---|---|
| Started | 23 | 23 |
| Completed | 21 | 22 |
| Not completed | 2 | 1 |
| Withdrew: Withdrawal by subject | 2 | 1 |
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.
| West blot band intensity,arbitrary units | Group I (Propranolol Hydrochloride) | Group II (no Treatment) |
|---|---|---|
| Mean Level of CREB Phosphorylation | 1.34 ± .33 | 1.43 ± .46 |
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.
| kDa | Group I (Propranolol Hydrochloride) | Group II (no Treatment) |
|---|---|---|
| BAD Phosphorylation | 0 ± 0 | 0 ± 0 |
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.
| score on a scale | Group I (Propranolol Hydrochloride) | Group II (no Treatment) |
|---|---|---|
| Distress Score - National Comprehensive Cancer Network Distress Thermometer Questionnaire | 3.6 ± 2.3 | 2.7 ± 2.6 |
Difference in levels of transcripts that reflect ADRB2/PKA activation will be measured by real-time polymerase chain reaction in prostate tissue from men.
| relative gene expression | Group I (Propranolol Hydrochloride) | Group II (no Treatment) |
|---|---|---|
| Levels of Transcripts That Reflect ADRB2/PKA Activation | NA | NA |
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.
| nano mole (nm) per liter (L) | Group I (Propranolol Hydrochloride) | Group II (no Treatment) |
|---|---|---|
| Plasma Catecholamine Levels (Including Epinephrine) | 0.36 ± 0.22 | 0.34 ± 0.22 |
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.
| nanograms per milliliter (ng/ml) | Group I (Propranolol Hydrochloride) | Group II (no Treatment) |
|---|---|---|
| Plasma Propranolol Levels | 10.89 ± 4.58 | 0.00 ± 0.00 |
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.
| score on a scale | Group I (Propranolol Hydrochloride) | Group II (no Treatment) |
|---|---|---|
| Self-perceived Stress | 7.4 ± 2.3 | 8.2 ± 1.4 |
Collected over from baseline up to about 2 hours. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Group I (Propranolol Hydrochloride) | 0/23 (0%) | 0/23 (0%) | 0/23 (0%) |
| Group II (no Treatment) | 0/23 (0%) | 0/23 (0%) | 0/23 (0%) |
| Age, Categorical(Participants) | Group I (Propranolol Hydrochloride) | Group II (no Treatment) | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 8 | 9 | 17 |
| >=65 years | 15 | 14 | 29 |
| Age, Continuous(years) | Group I (Propranolol Hydrochloride) | Group II (no Treatment) | Total |
|---|---|---|---|
| Mean | 68.35 ± 6.21 | 64.61 ± 64.61 | 66.48 ± 6.71 |
| Sex: Female, Male(Participants) | Group I (Propranolol Hydrochloride) | Group II (no Treatment) | Total |
|---|---|---|---|
| Female | 0 | 0 | 0 |
| Male | 23 | 23 | 46 |
| Race (NIH/OMB)(Participants) | Group I (Propranolol Hydrochloride) | Group II (no Treatment) | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 6 | 5 | 11 |
| White | 15 | 18 | 33 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 2 | 0 | 2 |
| Region of Enrollment(participants) | Group I (Propranolol Hydrochloride) | Group II (no Treatment) | Total |
|---|---|---|---|
| United States | 23 | 23 | 46 |
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Wake Forest University Health Sciences