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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2017-00788 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| CCCWFU 85716 | Other Identifier | Comprehensive Cancer Center of Wake Forest University | |
| P30CA012197 | U.S. NIH Grant/Contract | View source |
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PIs not interested in continuing with the trial.
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group I (propranolol hydrochloride) | Experimental | Patients receive propranolol hydrochloride PO 2 hours prior to standard of care prostatectomy. |
|
| Group II (no treatment) | Active Comparator | Patients receive no treatment prior to standard of care prostatectomy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Laboratory Biomarker Analysis | Other | Correlative studies |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean Level of CREB Phosphorylation | 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. | 2 hours after taking or not taking propranolol prior to prostatectomy |
| Measure | Description | Time Frame |
|---|---|---|
| BAD Phosphorylation | 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 hours after taking or not taking propranolol prior to prostatectomy |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ashok Hemal | Wake Forest University Health Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Comprehensive Cancer Center of Wake Forest University | Winston-Salem | North Carolina | 27157 | United States |
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January 15, 2019 to June 8, 2021
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| ID | Title | Description |
|---|---|---|
| FG000 | Group I (Propranolol Hydrochloride) | Patients receive propranolol hydrochloride PO 2 hours prior to standard of care prostatectomy. Laboratory Biomarker Analysis: Correlative studies Propranolol Hydrochloride: Given PO Questionnaire Administration: Ancillary studies Survey Administration: Ancillary studies |
| FG001 | Group II (no Treatment) | Patients receive no treatment prior to standard of care prostatectomy. Laboratory Biomarker Analysis: Correlative studies Questionnaire Administration: Ancillary studies Survey Administration: Ancillary studies |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Group I (Propranolol Hydrochloride) | Patients receive propranolol hydrochloride PO 2 hours prior to standard of care prostatectomy. Laboratory Biomarker Analysis: Correlative studies Propranolol Hydrochloride: Given PO Questionnaire Administration: Ancillary studies Survey Administration: Ancillary studies |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Mean Level of CREB Phosphorylation | 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. | levels of total CREB signal were below detection limit in missing participants | Posted | Mean | Standard Deviation | West blot band intensity,arbitrary units | 2 hours after taking or not taking propranolol prior to prostatectomy |
|
from baseline up to about 2 hours
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Group I (Propranolol Hydrochloride) | Patients receive propranolol hydrochloride PO 2 hours prior to standard of care prostatectomy. Laboratory Biomarker Analysis: Correlative studies Propranolol Hydrochloride: Given PO Questionnaire Administration: Ancillary studies Survey Administration: Ancillary studies |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Ashok Hemal, MD | Wake Forest School of Medicine | 336-716-5694 | ahemal@wakehealth.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 24, 2021 | Mar 18, 2024 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Apr 19, 2021 | Aug 5, 2022 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D011433 | Propranolol |
| C477592 | propranolol CR |
| ID | Term |
|---|---|
| D050198 | Phenoxypropanolamines |
| D011412 | Propanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
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| Propranolol Hydrochloride | Drug | Given PO |
|
|
| Questionnaire Administration | Other | Ancillary studies |
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| Survey Administration | Other | Ancillary studies |
|
| Distress Score - National Comprehensive Cancer Network Distress Thermometer Questionnaire | 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. | On the day of surgery before taking propranolol, prior to prostatectomy |
| Levels of Transcripts That Reflect ADRB2/PKA Activation | 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 hours after taking or not taking propranolol prior to prostatectomy |
| Plasma Catecholamine Levels (Including Epinephrine) | 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. | 2 hours after taking or not taking propranolol prior to prostatectomy |
| Plasma Propranolol Levels | 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. | 2 hours after taking or not taking propranolol prior to prostatectomy |
| Self-perceived Stress | 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. | On the day of surgery before taking propranolol, prior to prostatectomy |
| Group II (no Treatment) |
Patients receive no treatment prior to standard of care prostatectomy. Laboratory Biomarker Analysis: Correlative studies Questionnaire Administration: Ancillary studies Survey Administration: Ancillary studies |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
|
| OG001 | Group II (no Treatment) | Patients receive no treatment prior to standard of care prostatectomy. Laboratory Biomarker Analysis: Correlative studies Questionnaire Administration: Ancillary studies Survey Administration: Ancillary studies |
|
|
| Secondary | BAD Phosphorylation | 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. | BAD phosphorylation not detected | Posted | Mean | Standard Deviation | kDa | 2 hours after taking or not taking propranolol prior to prostatectomy |
|
|
|
| Secondary | Distress Score - National Comprehensive Cancer Network Distress Thermometer Questionnaire | 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. | Posted | Mean | Standard Deviation | score on a scale | On the day of surgery before taking propranolol, prior to prostatectomy |
|
|
|
| Secondary | Levels of Transcripts That Reflect ADRB2/PKA Activation | Difference in levels of transcripts that reflect ADRB2/PKA activation will be measured by real-time polymerase chain reaction in prostate tissue from men. | insufficient material for RNA extraction | Posted | Mean | Standard Deviation | relative gene expression | 2 hours after taking or not taking propranolol prior to prostatectomy |
|
|
|
| Secondary | Plasma Catecholamine Levels (Including Epinephrine) | 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. | one blood sample was missing during Epi measurement | Posted | Mean | Standard Deviation | nano mole (nm) per liter (L) | 2 hours after taking or not taking propranolol prior to prostatectomy |
|
|
|
| Secondary | Plasma Propranolol Levels | 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. | Number of samples collected for analysis. | Posted | Mean | Standard Deviation | nanograms per milliliter (ng/ml) | 2 hours after taking or not taking propranolol prior to prostatectomy |
|
|
|
| Secondary | Self-perceived Stress | 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. | Posted | Mean | Standard Deviation | score on a scale | On the day of surgery before taking propranolol, prior to prostatectomy |
|
|
|
| 0 |
| 23 |
| 0 |
| 23 |
| 0 |
| 23 |
| EG001 | Group II (no Treatment) | Patients receive no treatment prior to standard of care prostatectomy. Laboratory Biomarker Analysis: Correlative studies Questionnaire Administration: Ancillary studies Survey Administration: Ancillary studies | 0 | 23 | 0 | 23 | 0 | 23 |
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| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
| D009930 |
| Organic Chemicals |
| D020005 | Propanols |
| D000588 | Amines |
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D011083 | Polycyclic Compounds |