Evaluating the Effect of ADRB2 Blockers on PKA/BAD/CREB Signaling in Patients Undergoing Prostatectomy
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 46
- 试验地点
- 1
- 主要终点
- Mean Level of CREB Phosphorylation
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of prostate cancer undergoing prostatectomy
- •Individuals able to understand and willing to sign an Institutional Review Board (IRB)-approved informed consent document
排除标准
- •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
研究组 & 干预措施
Group I (propranolol hydrochloride)
Patients receive propranolol hydrochloride PO 2 hours prior to standard of care prostatectomy.
干预措施: Propranolol Hydrochloride (Drug)
Group I (propranolol hydrochloride)
Patients receive propranolol hydrochloride PO 2 hours prior to standard of care prostatectomy.
干预措施: Laboratory Biomarker Analysis (Other)
Group I (propranolol hydrochloride)
Patients receive propranolol hydrochloride PO 2 hours prior to standard of care prostatectomy.
干预措施: Survey Administration (Other)
Group II (no treatment)
Patients receive no treatment prior to standard of care prostatectomy.
干预措施: Laboratory Biomarker Analysis (Other)
Group II (no treatment)
Patients receive no treatment prior to standard of care prostatectomy.
干预措施: Questionnaire Administration (Other)
Group II (no treatment)
Patients receive no treatment prior to standard of care prostatectomy.
干预措施: Survey Administration (Other)
Group I (propranolol hydrochloride)
Patients receive propranolol hydrochloride PO 2 hours prior to standard of care prostatectomy.
干预措施: Questionnaire Administration (Other)
结局指标
主要结局
Mean Level of CREB Phosphorylation
时间窗: 2 hours after taking or not taking propranolol prior to prostatectomy
Determined using western blot in prostate tissue from men. CREB is a type of protein that binds to DNA in very specific places. CREB is related to long-term memory formation in the brain and is important in the formation of spatial memory. Phosphorylation alters the structural conformation of a protein, causing it to become activated, deactivated, or otherwise modifying its function. The level of CREB phosphorylation is an indicator of BAD activity.
次要结局
- BAD Phosphorylation(2 hours after taking or not taking propranolol prior to prostatectomy)
- Distress Score - National Comprehensive Cancer Network Distress Thermometer Questionnaire(On the day of surgery before taking propranolol, prior to prostatectomy)
- Levels of Transcripts That Reflect ADRB2/PKA Activation(2 hours after taking or not taking propranolol prior to prostatectomy)
- Plasma Catecholamine Levels (Including Epinephrine)(2 hours after taking or not taking propranolol prior to prostatectomy)
- Plasma Propranolol Levels(2 hours after taking or not taking propranolol prior to prostatectomy)
- Self-perceived Stress(On the day of surgery before taking propranolol, prior to prostatectomy)