Prostate CarcinomaPhase 2NCT03152786
Propranolol Hydrochloride in Treating Patients With Prostate Cancer Undergoing Surgery
A Phase 2 study testing Laboratory Biomarker Analysis, Propranolol Hydrochloride and Questionnaire Administration in people with Prostate Carcinoma, run by Wake Forest University Health Sciences at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 19 years and older, men only
- Conditions the study is for
- Prostate Carcinoma
- What is being tested?
- Laboratory Biomarker Analysis, Propranolol Hydrochloride and Questionnaire Administration
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Jan 2019to 28 Feb 2023
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of prostate cancer undergoing prostatectomy
- Individuals able to understand and willing to sign an Institutional Review Board (IRB)-approved informed consent document
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Comprehensive Cancer Center of Wake Forest University
Winston-Salem, North Carolina, 27157
About this study
Official title: Evaluating the Effect of ADRB2 Blockers on PKA/BAD/CREB Signaling in Patients Undergoing Prostatectomy
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.
Read the detailed description
PRIMARY OBJECTIVES:
- 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:
- 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.
- 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
- Being tested
- Laboratory Biomarker Analysis, Propranolol Hydrochloride, Questionnaire Administration, Survey Administration
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laboratory Biomarker AnalysisOther
Correlative studies
Propranolol HydrochlorideDrug
Also called Inderal, Innopran XL
Given PO
Questionnaire AdministrationOther
Ancillary studies
Survey AdministrationOther
Ancillary studies
| Study group | Role | What they receive |
|---|---|---|
| Group I (propranolol hydrochloride) | Experimental | Patients receive propranolol hydrochloride PO 2 hours prior to standard of care prostatectomy. Receives: Other: Laboratory Biomarker Analysis; Drug: Propranolol Hydrochloride; Other: Questionnaire Administration; Other: Survey Administration |
| Group II (no treatment) | Active comparator | Patients receive no treatment prior to standard of care prostatectomy. Receives: Other: Laboratory Biomarker Analysis; Other: Questionnaire Administration; Other: Survey Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 hours after taking or not taking propranolol prior to prostatectomy
Secondary outcomes (6)
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.
Measured: 2 hours after taking or not taking propranolol prior to prostatectomy
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: On the day of surgery before taking propranolol, prior to prostatectomy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2017
- Study start15 Jan 2019
- Primary completion15 Jun 2021
- Study completion28 Feb 2023
Why it stopped: PIs not interested in continuing with the trial.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Prostate CarcinomaStudies of the same condition, open and under way.
- More trials run by Wake Forest University Health SciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Ashok Hemal, Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03152786
- Sponsor's protocol ID
- IRB00043227
- Other IDs
- NCI-2017-00788, CCCWFU 85716, P30CA012197
- Status last verified
- Jul 2026
- First submitted
- 9 May 2017
- Last updated
- 3 Aug 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Effect of ADRB2 Blockers on PKA/BAD/CREB Signaling in Patients Undergoing Prostatectomy
- ClinicalTrials.gov ID
- NCT03152786
- Acronym / sponsor ID
- IRB00043227
- Conditions
- Prostate Carcinoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: PIs not interested in continuing with the trial.
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 15 Jan 2019 (actual)
- Primary completion
- 15 Jun 2021 (actual)
- Study completion
- 28 Feb 2023 (actual)
- First posted
- 15 May 2017 (actual)
- Results
- Posted 17 Feb 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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:
- 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.
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group I (propranolol hydrochloride) | Experimental | Other: Laboratory Biomarker Analysis, Drug: Propranolol Hydrochloride, Other: Questionnaire Administration, Other: Survey AdministrationPatients receive propranolol hydrochloride PO 2 hours prior to standard of care prostatectomy. |
| Group II (no treatment) | Active comparator | Other: Laboratory Biomarker Analysis, Other: Questionnaire Administration, Other: Survey AdministrationPatients receive no treatment prior to standard of care prostatectomy. |
Who may qualify
- Ages
- 19 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Diagnosis of prostate cancer undergoing prostatectomy
- Individuals able to understand and willing to sign an Institutional Review Board (IRB)-approved informed consent document
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Laboratory Biomarker AnalysisCorrelative studies | Other | Group I (propranolol hydrochloride), Group II (no treatment) |
| Propranolol HydrochlorideAlso: Inderal, Innopran XLGiven PO | Drug | Group I (propranolol hydrochloride) |
| Questionnaire AdministrationAncillary studies | Other | Group I (propranolol hydrochloride), Group II (no treatment) |
| Survey AdministrationAncillary studies | Other | Group I (propranolol hydrochloride), Group II (no treatment) |
Primary outcome
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.
6 secondary outcomes
BAD Phosphorylation
Time frame: 2 hours after taking or not taking propranolol prior to prostatectomy
Distress Score - National Comprehensive Cancer Network Distress Thermometer Questionnaire
Time frame: On the day of surgery before taking propranolol, prior to prostatectomy
Levels of Transcripts That Reflect ADRB2/PKA Activation
Time frame: 2 hours after taking or not taking propranolol prior to prostatectomy
Plasma Catecholamine Levels (Including Epinephrine)
Time frame: 2 hours after taking or not taking propranolol prior to prostatectomy
Plasma Propranolol Levels
Time frame: 2 hours after taking or not taking propranolol prior to prostatectomy
Self-perceived Stress
Time frame: On the day of surgery before taking propranolol, prior to prostatectomy
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ashok Hemal principal investigator
Wake Forest University Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Laboratory Biomarker Analysis, Propranolol Hydrochloride and Questionnaire Administration in people with Prostate Carcinoma, run by Wake Forest University Health Sciences at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 3 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 17 Feb 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean Level of CREB Phosphorylation (time frame: 2 hours after taking or not taking propranolol prior to prostatectomy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2026.