Hormone-Resistant Prostate CancerNCT03122743
Collection of Serum Samples in Studying Emotional Stress in Patients With Prostate Cancer
An observational study of Hormone-Resistant Prostate Cancer and Recurrent Prostate Carcinoma, run by Wake Forest University Health Sciences at 1 site in United States.
Trial summary
This pilot research trial studies the collection of serum samples in studying emotional stress in patients with prostate cancer. Studying serum samples from patients with prostate cancer in the laboratory may help doctors determine if levels of epinephrine and cortisol, substances the body makes when stressed, rise or… Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Hormone-Resistant Prostate Cancer, Recurrent Prostate Carcinoma, Stage I Prostate Cancer
- What is being tested?
- Biospecimen Collection, Laboratory Biomarker Analysis and Questionnaire Administration
- Type of treatment
- Surgery or procedure
- How many people
- 61 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Feb 2017to 24 Sep 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
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 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: Adult men with prostate cancer
Who may be able to join
- A confirmed diagnosis of prostate cancer
- Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, 2
- Individuals able to understand and willing to sign an Institutional Review Board (IRB)-approved informed consent document
Who cannot join
- 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: Correlation of Serum Catecholamine With Emotional Stress in Men With Prostate Cancer: A Pilot Study
This pilot research trial studies the collection of serum samples in studying emotional stress in patients with prostate cancer. Studying serum samples from patients with prostate cancer in the laboratory may help doctors determine if levels of epinephrine and cortisol, substances the body makes when stressed, rise or fall with how patients are feeling and/or if those levels are related to clinical information related to prostate cancer.
Read the detailed description
PRIMARY OBJECTIVES:
- To determine if serum epinephrine or cortisol levels in men with prostate cancer correlate with perceived stress or distress over time in two to five consecutive visits.
SECONDARY OBJECTIVES:
- To determine the change in serum epinephrine levels in men with prostate cancer over time in two to five consecutive visits.
II. To determine the change in serum cortisol levels in men with prostate cancer over time in two to five consecutive visits.
III. To determine the change in levels of stress in men with prostate cancer over time in two to five consecutive visits IV. To determine the change in levels of distress in men with prostate cancer over time in two to five consecutive visits.
TERTIARY OBJECTIVES:
- To determine if serum epinephrine or cortisol levels in men with prostate cancer correlate with prostate cancer progression two to five visits.
OUTLINE:
Patients undergo collection of serum samples for epinephrine and cortisol levels at baseline and 4 clinical visits. Patients also receive the Self-Perceived Stress questionnaire and the Distress Thermometer questionnaire to measure perceived stress.
- Conditions
- Hormone-Resistant Prostate Cancer, Recurrent Prostate Carcinoma, Stage I Prostate Cancer, Stage II Prostate Cancer, Stage IIA Prostate Cancer, Stage IIB Prostate Cancer
- Being tested
- Biospecimen Collection, Laboratory Biomarker Analysis, Questionnaire 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.
Biospecimen CollectionProcedure or surgery
Undergo collection of serum samples
Laboratory Biomarker AnalysisOther
Correlative studies
Questionnaire AdministrationOther
Ancillary studies
| Study group | Role | What they receive |
|---|---|---|
| Ancillary-Correlative (collection of samples, questionnaires) | Patients undergo collection of serum samples for epinephrine and cortisol levels at baseline and 4 clinical visits. Patients also receive the Self-Perceived Stress questionnaire and the Distress Thermometer questionnaire to measure perceived stress. Receives: Procedure: Biospecimen Collection; Other: Laboratory Biomarker Analysis; Other: Questionnaire Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in distress score, assessed by the Distress Thermometer
Will calculate the patient's stress levels at each of the 5 visits using a validated distress thermometer
Measured: Up to 1 year
Change in perceived stress scores, assessed by the Self-Perceived Stress Questionnaire
Will calculate the patient's stress levels at each of the 5 visits using a validated measure of self-perceived stress
Measured: Up to 1 year
Change in serum cortisol levels
Will calculate the change in serum cortisol levels between the first and last assessment and calculate the corresponding change in perceived stress or distress during the same time period. Will estimate the Pearson correlation between the two changes. Will also estimate a 95% confidence interval for this estimated correlation. These calculations will be performed overall (pooling all 3 groups together) and then repeated for each of the three groups of men separately. Will fit a longitudinal mixed model that incorporates the repeated measures taken on each patient. Additional int
Measured: Up to 1 year
Change in serum epinephrine levels
Will calculate the change in serum epinephrine levels between the first and last assessment and calculate the corresponding change in perceived stress or distress during the same time period. Will estimate the Pearson correlation between the two changes. Will also estimate a 95% confidence interval for this estimated correlation. These calculations will be performed overall (pooling all 3 groups together) and then repeated for each of the three groups of men separately. Will fit a longitudinal mixed model that incorporates the repeated measures taken on each patient. Additional int
Measured: Up to 1 year
Secondary outcomes (4)
Change in levels of distress assessed by the Distress Thermometer
Will fit a two-way random effects model to examine the time course of distress levels.
Measured: Baseline up to 1 year
Change in self-perceived stress, assessed by the Self-Perceived Stress Questionnaire
Will fit a two-way random effects model to examine the time course of stress levels.
Measured: Baseline up to 1 year
Change in serum cortisol levels
Will fit a two-way random effects model to examine the time course of serum cortisol levels.
Measured: Baseline up to 1 year
Change in serum epinephrine levels
Will fit a two-way random effects model to examine the time course of serum epinephrine levels.
Measured: Baseline up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2017
- Study start22 Feb 2017
- Primary completion24 Sep 2020
- Study completion24 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hormone-Resistant Prostate CancerStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 61 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
- Bart Frizzell, Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03122743
- Sponsor's protocol ID
- IRB00041151
- Other IDs
- NCI-2016-01590, CCCWFU 85316, P30CA012197
- Status last verified
- Mar 2022
- First submitted
- 27 Oct 2016
- Last updated
- 10 Mar 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlation of Serum Catecholamine With Emotional Stress in Men With Prostate Cancer: A Pilot Study
- ClinicalTrials.gov ID
- NCT03122743
- Acronym / sponsor ID
- IRB00041151
- Conditions
- Hormone-Resistant Prostate Cancer, Recurrent Prostate Carcinoma, Stage I Prostate Cancer, Stage II Prostate Cancer, Stage IIA Prostate Cancer, Stage IIB Prostate Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 22 Feb 2017 (actual)
- Primary completion
- 24 Sep 2020 (actual)
- Study completion
- 24 Sep 2020 (actual)
- First posted
- 21 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This pilot research trial studies the collection of serum samples in studying emotional stress in patients with prostate cancer. Studying serum samples from patients with prostate cancer in the laboratory may help doctors determine if levels of epinephrine and cortisol, substances the body makes when stressed, rise or fall with how patients are feeling and/or if those levels are related to clinical information related to prostate cancer.
Detailed description
PRIMARY OBJECTIVES:
- To determine if serum epinephrine or cortisol levels in men with prostate cancer correlate with perceived stress or distress over time in two to five consecutive visits.
SECONDARY OBJECTIVES:
- To determine the change in serum epinephrine levels in men with prostate cancer over time in two to five consecutive visits.
II. To determine the change in serum cortisol levels in men with prostate cancer over time in two to five consecutive visits.
III. To determine the change in levels of stress in men with prostate cancer over time in two to five consecutive visits IV. To determine the change in levels of distress in men with prostate cancer over time in two to five consecutive visits.
TERTIARY OBJECTIVES:
- To determine if serum epinephrine or cortisol levels in men with prostate cancer correlate with prostate cancer progression two to five visits.
OUTLINE:
Patients undergo collection of serum samples for epinephrine and cortisol levels at baseline and 4 clinical visits. Patients also receive the Self-Perceived Stress questionnaire and the Distress Thermometer questionnaire to measure perceived stress.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ancillary-Correlative (collection of samples, questionnaires) | – | Procedure: Biospecimen Collection, Other: Laboratory Biomarker Analysis, Other: Questionnaire AdministrationPatients undergo collection of serum samples for epinephrine and cortisol levels at baseline and 4 clinical visits. Patients also receive the Self-Perceived Stress questionnaire and the Distress Thermometer questionnaire to measure perceived stress. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult men with prostate cancer
Key inclusion criteria (3 listed)
- A confirmed diagnosis of prostate cancer
- Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, 2
- Individuals able to understand and willing to sign an Institutional Review Board (IRB)-approved informed consent document
Key exclusion criteria (1 listed)
- 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 |
|---|---|---|
| Biospecimen CollectionUndergo collection of serum samples | Procedure or surgery | Ancillary-Correlative (collection of samples, questionnaires) |
| Laboratory Biomarker AnalysisCorrelative studies | Other | Ancillary-Correlative (collection of samples, questionnaires) |
| Questionnaire AdministrationAncillary studies | Other | Ancillary-Correlative (collection of samples, questionnaires) |
Primary outcome
Change in distress score, assessed by the Distress Thermometer
Time frame: Up to 1 year
Will calculate the patient's stress levels at each of the 5 visits using a validated distress thermometer
Change in perceived stress scores, assessed by the Self-Perceived Stress Questionnaire
Time frame: Up to 1 year
Will calculate the patient's stress levels at each of the 5 visits using a validated measure of self-perceived stress
Change in serum cortisol levels
Time frame: Up to 1 year
Will calculate the change in serum cortisol levels between the first and last assessment and calculate the corresponding change in perceived stress or distress during the same time period. Will estimate the Pearson correlation between the two changes. Will also estimate a 95% confidence interval for this estimated correlation. These calculations will be performed overall (pooling all 3 groups together) and then repeated for each of the three groups of men separately. Will fit a longitudinal mixed model that incorporates the repeated measures taken on each patient. Additional int
Change in serum epinephrine levels
Time frame: Up to 1 year
Will calculate the change in serum epinephrine levels between the first and last assessment and calculate the corresponding change in perceived stress or distress during the same time period. Will estimate the Pearson correlation between the two changes. Will also estimate a 95% confidence interval for this estimated correlation. These calculations will be performed overall (pooling all 3 groups together) and then repeated for each of the three groups of men separately. Will fit a longitudinal mixed model that incorporates the repeated measures taken on each patient. Additional int
4 secondary outcomes
Change in levels of distress assessed by the Distress Thermometer
Time frame: Baseline up to 1 year
Change in self-perceived stress, assessed by the Self-Perceived Stress Questionnaire
Time frame: Baseline up to 1 year
Change in serum cortisol levels
Time frame: Baseline up to 1 year
Change in serum epinephrine levels
Time frame: Baseline up to 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2022.
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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.
Bart Frizzell 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?
An observational study of Hormone-Resistant Prostate Cancer and Recurrent 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 3 inclusion and 1 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: finished, as of the sponsor's last update on 10 Mar 2022. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change in distress score, assessed by the Distress Thermometer (time frame: Up to 1 year). The study lists 4 primary outcomes in all. 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 10 Mar 2022.