Propranolol Hydrochloride in Treating Patients With Prostate Cancer Undergoing Surgery

Wake Forest University (WFU)

Status and phase: Terminated; Phase 2

Conditions: Prostate Carcinoma

Treatments: Other: Survey Administration; Other: Questionnaire Administration; Other: Laboratory Biomarker Analysis; Drug: Propranolol Hydrochloride

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03152786

P30CA012197 (U.S. NIH Grant/Contract)

NCI-2017-00788 (Registry Identifier)

CCCWFU 85716 (Other Identifier)

IRB00043227

Details and patient eligibility

About

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.

Full 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.

Enrollment: 46 patients

Sex: Male

Ages: 19+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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46 participants in 2 patient groups

Group I (propranolol hydrochloride)

Experimental group

Description:

Patients receive propranolol hydrochloride PO 2 hours prior to standard of care prostatectomy.

Treatment:

Drug: Propranolol Hydrochloride

Other: Laboratory Biomarker Analysis

Other: Questionnaire Administration

Other: Survey Administration

Group II (no treatment)

Active Comparator group

Description:

Patients receive no treatment prior to standard of care prostatectomy.

Treatment:

Other: Laboratory Biomarker Analysis

Other: Questionnaire Administration

Other: Survey Administration