Clinical trial NCT03122743: Collection of Serum Samples in Studying Emotional Stress in Patients With Prostate Cancer
Official title: Correlation of Serum Catecholamine With Emotional Stress in Men With Prostate Cancer: A Pilot Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hormone-Resistant Prostate Cancer
Recurrent Prostate Carcinoma
Stage I Prostate Cancer
Stage II Prostate Cancer
Stage IIA Prostate Cancer
Stage IIB Prostate Cancer
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2017-04-21
Enrollment: 61
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult men with prostate cancer

Brief 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 fall with how patients are feeling and/or if those levels are related to clinical information related to prostate cancer.

Detailed description: PRIMARY OBJECTIVES:

I. 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:

I. 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:

I. 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Change in distress score, assessed by the Distress Thermometer
timeFrame: Up to 1 year
measure: Change in perceived stress scores, assessed by the Self-Perceived Stress Questionnaire
timeFrame: Up to 1 year
measure: Change in serum cortisol levels
timeFrame: Up to 1 year
measure: Change in serum epinephrine levels
timeFrame: Up to 1 year
Secondary outcomes:
measure: Change in levels of distress assessed by the Distress Thermometer
timeFrame: Baseline up to 1 year
measure: Change in self-perceived stress, assessed by the Self-Perceived Stress Questionnaire
timeFrame: Baseline up to 1 year
measure: Change in serum cortisol levels
timeFrame: Baseline up to 1 year
measure: Change in serum epinephrine levels
timeFrame: Baseline up to 1 year
Other outcomes:
measure: Change in levels of serum prostate specific antigen in patients with complete response (CR), partial response (PR), stable disease (SD), or progressive disease (PD)
timeFrame: Baseline up to 1 year
measure: Change in serum cortisol AUC values
timeFrame: Baseline up to 1 year
measure: Change in serum epinephrine area under the curve (AUC) values
timeFrame: Baseline up to 1 year
Locations:
city: Winston-Salem
country: United States
facility: Comprehensive Cancer Center of Wake Forest University
state: North Carolina
Study officials:
affiliation: Wake Forest University Health Sciences
name: Bart Frizzell
role: PRINCIPAL_INVESTIGATOR
References: