Description:
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.
Title
- Brief Title: Propranolol Hydrochloride in Treating Patients With Prostate Cancer Undergoing Surgery
- Official Title: Evaluating the Effect of ADRB2 Blockers on PKA/BAD/CREB Signaling in Patients Undergoing Prostatectomy
Clinical Trial IDs
- ORG STUDY ID:
IRB00043227
- SECONDARY ID:
NCI-2017-00788
- SECONDARY ID:
CCCWFU 85716
- SECONDARY ID:
P30CA012197
- NCT ID:
NCT03152786
Conditions
Interventions
Drug | Synonyms | Arms |
---|
Propranolol Hydrochloride | Inderal, Innopran XL | Group I (propranolol hydrochloride) |
Purpose
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.
Trial Arms
Name | Type | Description | Interventions |
---|
Group I (propranolol hydrochloride) | Experimental | Patients receive propranolol hydrochloride PO 2 hours prior to standard of care prostatectomy. | - Propranolol Hydrochloride
|
Group II (no treatment) | Active Comparator | Patients receive no treatment prior to standard of care prostatectomy. | |
Eligibility 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
Maximum Eligible Age: | N/A |
Minimum Eligible Age: | 19 Years |
Eligible Gender: | Male |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | CREB phosphorylation |
Time Frame: | 2 hours after taking or not taking propranolol prior to prostatectomy |
Safety Issue: | |
Description: | Will be determined by western blot in prostate tissue from men. |
Secondary Outcome Measures
Measure: | BAD phosphorylation |
Time Frame: | 2 hours after taking or not taking propranolol prior to prostatectomy |
Safety Issue: | |
Description: | 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. |
Measure: | Distress score |
Time Frame: | On the day of surgery before taking propranolol, prior to prostatectomy |
Safety Issue: | |
Description: | 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. |
Measure: | Levels of transcripts that reflect ADRB2/PKA activation |
Time Frame: | 2 hours after taking or not taking propranolol prior to prostatectomy |
Safety Issue: | |
Description: | 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. |
Measure: | Plasma catecholamine levels (including epinephrine) |
Time Frame: | 2 hours after taking or not taking propranolol prior to prostatectomy |
Safety Issue: | |
Description: | 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. |
Measure: | Plasma propranolol levels |
Time Frame: | 2 hours after taking or not taking propranolol prior to prostatectomy |
Safety Issue: | |
Description: | 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. |
Measure: | Self-perceived stress |
Time Frame: | On the day of surgery before taking propranolol, prior to prostatectomy |
Safety Issue: | |
Description: | 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. |
Details
Phase: | Phase 2 |
Primary Purpose: | Interventional |
Overall Status: | Recruiting |
Lead Sponsor: | Wake Forest University Health Sciences |
Last Updated
June 18, 2021