Interindividual differences in stress sensitivity during MR-guided prostate biopsy

Completed

Conditions: prostate cancer
10018188

Registration Number: NL-OMON42574

Lead Sponsor: Radboud Universitair Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 51

Inclusion Criteria

In order to be eligible to participate in this study, a subject must meet all of the following criteria:;- 50 -70 years of age
- PSA * 4.0 ng/mL and/or positive digital rectal examination
- suspicious lesion (PIRADS 3 to 5) on diagnostic MR imaging examination
- Signed MRI screening form (to search for metal device/foreign bodies/claustrophobia)
- Signed IRB-approved informed consent form

Exclusion Criteria

- Patients unable to undergo MR imaging, including those with contra-indications
- Contra-indications to MR-guided prostate biopsy
- Impossibility to obtain a valid informed consent
- History of psychiatric treatment or current psychiatric treatment as revealed by self report.
- History of neurological treatment or current neurological treatment as revealed by self report.
- History of endocrine treatment or current endocrine treatment as revealed by self report.
- Claustrophobia.

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary objective of our study is to measure individual stress reactivity<br /><br>by means of self-assessment and cortisol changes in patients during MR-guided<br /><br>prostate biopsy. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>The subjective and physiological stress response while undergoing the<br /><br>diagnostic intervention will be associated to potential predictive markers in<br /><br>personality characteristics, habitual stress levels, coping abilities and<br /><br>stress-related brain connectivity patterns. Brain connectivity measures related<br /><br>to stress response, such as the interplay between the human salience and<br /><br>executive control networks [13], stress coping abilities, depression, anxiety,<br /><br>psychological burden and long term stress exposure may constitute vulnerability<br /><br>or resilience factors in relation to the peri-interventional stress response. </p><br>