Trial Outcomes & Findings for Propranolol Hydrochloride in Treating Patients With Prostate Cancer Undergoing Surgery (NCT NCT03152786)
NCT ID: NCT03152786
Last Updated: 2025-02-17
Results Overview
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.
TERMINATED
PHASE2
46 participants
2 hours after taking or not taking propranolol prior to prostatectomy
2025-02-17
Participant Flow
January 15, 2019 to June 8, 2021
Participant milestones
| Measure |
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
|
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
|
|---|---|---|
|
Overall Study
STARTED
|
23
|
23
|
|
Overall Study
COMPLETED
|
21
|
22
|
|
Overall Study
NOT COMPLETED
|
2
|
1
|
Reasons for withdrawal
| Measure |
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
|
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
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
2
|
1
|
Baseline Characteristics
Propranolol Hydrochloride in Treating Patients With Prostate Cancer Undergoing Surgery
Baseline characteristics by cohort
| Measure |
Group I (Propranolol Hydrochloride)
n=23 Participants
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
|
Group II (no Treatment)
n=23 Participants
Patients receive no treatment prior to standard of care prostatectomy.
Laboratory Biomarker Analysis: Correlative studies
Questionnaire Administration: Ancillary studies
Survey Administration: Ancillary studies
|
Total
n=46 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
8 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
15 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
|
Age, Continuous
|
68.35 years
STANDARD_DEVIATION 6.21 • n=5 Participants
|
64.61 years
STANDARD_DEVIATION 64.61 • n=7 Participants
|
66.48 years
STANDARD_DEVIATION 6.71 • n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
23 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
46 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
6 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
15 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
33 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
23 participants
n=5 Participants
|
23 participants
n=7 Participants
|
46 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 2 hours after taking or not taking propranolol prior to prostatectomyPopulation: levels of total CREB signal were below detection limit in missing participants
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.
Outcome measures
| Measure |
Group I (Propranolol Hydrochloride)
n=6 Participants
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
|
Group II (no Treatment)
n=5 Participants
Patients receive no treatment prior to standard of care prostatectomy.
Laboratory Biomarker Analysis: Correlative studies
Questionnaire Administration: Ancillary studies
Survey Administration: Ancillary studies
|
|---|---|---|
|
Mean Level of CREB Phosphorylation
|
1.34 West blot band intensity,arbitrary units
Standard Deviation .33
|
1.43 West blot band intensity,arbitrary units
Standard Deviation .46
|
SECONDARY outcome
Timeframe: 2 hours after taking or not taking propranolol prior to prostatectomyPopulation: BAD phosphorylation not detected
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.
Outcome measures
| Measure |
Group I (Propranolol Hydrochloride)
n=21 Participants
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
|
Group II (no Treatment)
n=22 Participants
Patients receive no treatment prior to standard of care prostatectomy.
Laboratory Biomarker Analysis: Correlative studies
Questionnaire Administration: Ancillary studies
Survey Administration: Ancillary studies
|
|---|---|---|
|
BAD Phosphorylation
|
0 kDa
Standard Deviation 0
|
0 kDa
Standard Deviation 0
|
SECONDARY outcome
Timeframe: On the day of surgery before taking propranolol, prior to prostatectomyWill 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.
Outcome measures
| Measure |
Group I (Propranolol Hydrochloride)
n=20 Participants
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
|
Group II (no Treatment)
n=23 Participants
Patients receive no treatment prior to standard of care prostatectomy.
Laboratory Biomarker Analysis: Correlative studies
Questionnaire Administration: Ancillary studies
Survey Administration: Ancillary studies
|
|---|---|---|
|
Distress Score - National Comprehensive Cancer Network Distress Thermometer Questionnaire
|
3.6 score on a scale
Standard Deviation 2.3
|
2.7 score on a scale
Standard Deviation 2.6
|
SECONDARY outcome
Timeframe: 2 hours after taking or not taking propranolol prior to prostatectomyPopulation: insufficient material for RNA extraction
Difference in levels of transcripts that reflect ADRB2/PKA activation will be measured by real-time polymerase chain reaction in prostate tissue from men.
Outcome measures
| Measure |
Group I (Propranolol Hydrochloride)
n=21 Participants
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
|
Group II (no Treatment)
n=22 Participants
Patients receive no treatment prior to standard of care prostatectomy.
Laboratory Biomarker Analysis: Correlative studies
Questionnaire Administration: Ancillary studies
Survey Administration: Ancillary studies
|
|---|---|---|
|
Levels of Transcripts That Reflect ADRB2/PKA Activation
|
NA relative gene expression
Standard Deviation NA
insufficient material for RNA extraction
|
NA relative gene expression
Standard Deviation NA
insufficient material for RNA extraction
|
SECONDARY outcome
Timeframe: 2 hours after taking or not taking propranolol prior to prostatectomyPopulation: one blood sample was missing during Epi measurement
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.
Outcome measures
| Measure |
Group I (Propranolol Hydrochloride)
n=7 Participants
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
|
Group II (no Treatment)
n=8 Participants
Patients receive no treatment prior to standard of care prostatectomy.
Laboratory Biomarker Analysis: Correlative studies
Questionnaire Administration: Ancillary studies
Survey Administration: Ancillary studies
|
|---|---|---|
|
Plasma Catecholamine Levels (Including Epinephrine)
|
0.36 nano mole (nm) per liter (L)
Standard Deviation 0.22
|
0.34 nano mole (nm) per liter (L)
Standard Deviation 0.22
|
SECONDARY outcome
Timeframe: 2 hours after taking or not taking propranolol prior to prostatectomyPopulation: Number of samples collected for analysis.
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.
Outcome measures
| Measure |
Group I (Propranolol Hydrochloride)
n=8 Participants
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
|
Group II (no Treatment)
n=8 Participants
Patients receive no treatment prior to standard of care prostatectomy.
Laboratory Biomarker Analysis: Correlative studies
Questionnaire Administration: Ancillary studies
Survey Administration: Ancillary studies
|
|---|---|---|
|
Plasma Propranolol Levels
|
10.89 nanograms per milliliter (ng/ml)
Standard Deviation 4.58
|
0.00 nanograms per milliliter (ng/ml)
Standard Deviation 0.00
|
SECONDARY outcome
Timeframe: On the day of surgery before taking propranolol, prior to prostatectomyWill 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.
Outcome measures
| Measure |
Group I (Propranolol Hydrochloride)
n=20 Participants
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
|
Group II (no Treatment)
n=23 Participants
Patients receive no treatment prior to standard of care prostatectomy.
Laboratory Biomarker Analysis: Correlative studies
Questionnaire Administration: Ancillary studies
Survey Administration: Ancillary studies
|
|---|---|---|
|
Self-perceived Stress
|
7.4 score on a scale
Standard Deviation 2.3
|
8.2 score on a scale
Standard Deviation 1.4
|
Adverse Events
Group I (Propranolol Hydrochloride)
Group II (no Treatment)
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place