NCT03122743

Collection of Serum Samples in Studying Emotional Stress in Patients With Prostate Cancer

Correlation of Serum Catecholamine With Emotional Stress in Men With Prostate Cancer: A Pilot Study

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 61 (actual)
• Sponsor: Wake Forest University Health Sciences · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Hormone-Resistant Prostate Cancer
• Recurrent Prostate Carcinoma
• Stage I Prostate Cancer
• Stage II Prostate Cancer
• Stage IIA Prostate Cancer
• Stage IIB Prostate Cancer

Interventions

Type	Name	Description
PROCEDURE	Biospecimen Collection	Undergo collection of serum samples
OTHER	Laboratory Biomarker Analysis	Correlative studies
OTHER	Questionnaire Administration	Ancillary studies

Timeline

• Start date: 2017-02-22
• Primary completion: 2020-09-24
• Completion: 2020-09-24
• First posted: 2017-04-21
• Last updated: 2022-03-10

Locations

1 site across 1 country: United States