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Terminated

NCT Number: NCT03152786

Propranolol Hydrochloride in Treating Patients With Prostate Cancer Undergoing Surgery

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.

Why the study stopped: PIs not interested in continuing with the trial.
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Key information

Conditions

Prostate Carcinoma Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

19 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Phase 2

Primary location

Comprehensive Cancer Center of Wake Forest University

Winston-Salem, North Carolina, 27157, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

laboratory biomarker analysis

Other

Correlative studies

Propranolol Hydrochloride

Drug

Given PO

Other names: Inderal, Innopran XL

Questionnaire Administration

Other

Ancillary studies

Survey Administration

Other

Ancillary studies

Primary outcomes

  1. Mean Level of CREB Phosphorylation

    Time frame: 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.

Secondary outcomes

  1. BAD Phosphorylation

    Time frame: 2 hours after taking or not taking propranolol prior to prostatectomy

    Will be assessed by western blot in prostate tissue from men. BAD is a protein that plays a critical role in cell survival. Phosphorylation alters the structural conformation of a protein, causing it to become activated, deactivated, or otherwise modifying its function. This analysis shows how much phosphorylation of BAD protein is happening in cells.

  2. Distress Score - National Comprehensive Cancer Network Distress Thermometer Questionnaire

    Time frame: On the day of surgery before taking propranolol, prior to prostatectomy

    Will be measured by The Distress Thermometer from men.

    The NCCN Distress Thermometer (DT) is a one-item, 11-point Likert scale represented on a visual graphic of a thermometer that ranges from 0 (no distress) to 10 (extreme distress), with which patients indicate their level of distress over the course of the week prior to assessment. Scoring scale ranges from 0 (no distress) to 10 (extreme distress) with higher scores indicating more distress.

  3. Levels of Transcripts That Reflect ADRB2/PKA Activation

    Time frame: 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.

  4. Plasma Catecholamine Levels (Including Epinephrine)

    Time frame: 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.

  5. Plasma Propranolol Levels

    Time frame: 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.

  6. Self-perceived Stress

    Time frame: On the day of surgery before taking propranolol, prior to prostatectomy

    Will be measured by The Perceived Stress Questionnaire from men. The perceived stress questionnaire is a set of 4 questions asking participants about their feelings/problems with stress over the last two weeks. Scoring scale ranges from 0 to 16 with higher scores indicating a higher level of stress.

Sponsors and collaborators

Lead sponsor

Wake Forest University Health Sciences

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2021
Study completion
2023
First posted
May 15, 2017
Registry last updated
Aug 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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