This randomized pilot clinical trial studies how well propranolol 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 may affect the signals in cells that cause tumor cells survival and death.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT03152786.
PRIMARY OBJECTIVE:
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 prostate biopsy or 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 prostate biopsy or 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 prostate biopsy or prostatectomy.
III. To determine plasma propranolol levels in individuals taking propranolol two hours after administration prior to prostate biopsy or 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 prostate biopsy or prostatectomy 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 prostate biopsy or prostatectomy to examine possible association between distress level and catecholamine levels in blood and activation of ADRB2 pathway in 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 prostate biopsy or prostatectomy.
GROUP II: Patients receive no treatment prior to standard of care prostate biopsy or prostatectomy.
After completion of study treatment, patients are followed up for 30 days.
Lead OrganizationWake Forest University Health Sciences
Principal InvestigatorAshok K. Hemal
