Clinical trial NCT03152786: 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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Prostate Carcinoma
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2017-05-15
Enrollment: 46
Sex: MALE
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

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

Primary outcomes:
measure: Mean Level of CREB Phosphorylation
timeFrame: 2 hours after taking or not taking propranolol prior to prostatectomy
Secondary outcomes:
measure: BAD Phosphorylation
timeFrame: 2 hours after taking or not taking propranolol prior to prostatectomy
measure: Distress Score - National Comprehensive Cancer Network Distress Thermometer Questionnaire
timeFrame: On the day of surgery before taking propranolol, prior to prostatectomy
measure: Levels of Transcripts That Reflect ADRB2/PKA Activation
timeFrame: 2 hours after taking or not taking propranolol prior to prostatectomy
measure: Plasma Catecholamine Levels (Including Epinephrine)
timeFrame: 2 hours after taking or not taking propranolol prior to prostatectomy
measure: Plasma Propranolol Levels
timeFrame: 2 hours after taking or not taking propranolol prior to prostatectomy
measure: Self-perceived Stress
timeFrame: On the day of surgery before taking propranolol, prior to prostatectomy
Other outcomes:
Locations:
city: Winston-Salem
country: United States
facility: Comprehensive Cancer Center of Wake Forest University
state: North Carolina
Study officials:
affiliation: Wake Forest University Health Sciences
name: Ashok Hemal
role: PRINCIPAL_INVESTIGATOR
References: