Propranolol Hydrochloride in Treating Patients With Prostate Cancer Undergoing Surgery
Status: | Recruiting |
---|---|
Conditions: | Prostate Cancer |
Therapuetic Areas: | Oncology |
Healthy: | No |
Age Range: | 19 - Any |
Updated: | 3/6/2019 |
Start Date: | February 12, 2018 |
End Date: | February 2020 |
Evaluating the Effect of ADRB2 Blockers on PKA/BAD/CREB Signaling in Patients Undergoing Prostatectomy
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.
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.
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.
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
We found this trial at
1
site
Medical Center Boulevard
Winston-Salem, North Carolina 27157
Winston-Salem, North Carolina 27157
336-716-2255
Principal Investigator: Ashok K. Hemal
Phone: 336-716-5694
Comprehensive Cancer Center of Wake Forest University Our newly expanded Comprehensive Cancer Center is the...
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