NCT03152786

Propranolol Hydrochloride in Treating Patients With Prostate Cancer Undergoing Surgery

Evaluating the Effect of ADRB2 Blockers on PKA/BAD/CREB Signaling in Patients Undergoing Prostatectomy

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 46 (actual)
• Sponsor: Wake Forest University Health Sciences · Academic / Other
• Sex: Male
• Age: 19 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Prostate Carcinoma

Interventions

Type	Name	Description
OTHER	Laboratory Biomarker Analysis	Correlative studies
DRUG	Propranolol Hydrochloride	Given PO
OTHER	Questionnaire Administration	Ancillary studies
OTHER	Survey Administration	Ancillary studies

Timeline

• Start date: 2019-01-15
• Primary completion: 2021-06-15
• Completion: 2023-02-28
• First posted: 2017-05-15
• Last updated: 2025-02-17
• Results posted: 2025-02-17

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study