Propranolol Hydrochloride in Treating Patients With Prostate Cancer Undergoing Surgery

Phase 2

Terminated

• Conditions: Prostate Carcinoma
• Interventions: Other: Laboratory Biomarker Analysis; Drug: Propranolol Hydrochloride; Other: Questionnaire Administration; Other: Survey Administration

• Registration Number: NCT03152786
• Lead Sponsor: Wake Forest University Health Sciences

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.

Study Timeline

• Study First Submitted: 2017-05-09
• Study First Submitted QC: 2017-05-11
• Study First Posted: 2017-05-15
• Study Start: 2019-01-15
• Primary Completion: 2021-06-15
• Study Completion: 2023-02-28
• Status Verified: 2023-07
• Last Update Submitted: 2023-07-13
• Last Update Posted: 2023-07-17

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Male
• Target Recruitment: 46

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group I (propranolol hydrochloride)	Questionnaire Administration	Patients receive propranolol hydrochloride PO 2 hours prior to standard of care prostatectomy.
Group I (propranolol hydrochloride)	Laboratory Biomarker Analysis	Patients receive propranolol hydrochloride PO 2 hours prior to standard of care prostatectomy.
Group I (propranolol hydrochloride)	Propranolol Hydrochloride	Patients receive propranolol hydrochloride PO 2 hours prior to standard of care prostatectomy.
Group I (propranolol hydrochloride)	Survey Administration	Patients receive propranolol hydrochloride PO 2 hours prior to standard of care prostatectomy.
Group II (no treatment)	Laboratory Biomarker Analysis	Patients receive no treatment prior to standard of care prostatectomy.
Group II (no treatment)	Questionnaire Administration	Patients receive no treatment prior to standard of care prostatectomy.
Group II (no treatment)	Survey Administration	Patients receive no treatment prior to standard of care prostatectomy.

Primary Outcome Measures

Name	Time	Method
CREB phosphorylation	2 hours after taking or not taking propranolol prior to prostatectomy	Will be determined by western blot in prostate tissue from men.

Secondary Outcome Measures

Name	Time	Method
Levels of transcripts that reflect ADRB2/PKA activation	2 hours after taking or not taking propranolol prior to prostatectomy	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.
Self-perceived stress	On the day of surgery before taking propranolol, prior to prostatectomy	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.
Distress score	On the day of surgery before taking propranolol, prior to prostatectomy	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.
Plasma propranolol levels	2 hours after taking or not taking propranolol prior to prostatectomy	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.
BAD phosphorylation	2 hours after taking or not taking propranolol prior to prostatectomy	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.
Plasma catecholamine levels (including epinephrine)	2 hours after taking or not taking propranolol prior to prostatectomy	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.

Trial Locations

Locations (1)

Comprehensive Cancer Center of Wake Forest University; 🇺🇸 Winston-Salem, North Carolina, United States