The purpose of our study is to assess the subjective stress response during MR guided prostate biopsy and elucidate potential mediating influences of cognitive and affective factors, long term stress exposure and stress-related brain connectivity…
ID
Source
Brief title
Condition
- Genitourinary tract disorders NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary objective of our study is to measure individual stress reactivity
by means of self-assessment and cortisol changes in patients during MR-guided
prostate biopsy.
Secondary outcome
The subjective and physiological stress response while undergoing the
diagnostic intervention will be associated to potential predictive markers in
personality characteristics, habitual stress levels, coping abilities and
stress-related brain connectivity patterns. Brain connectivity measures related
to stress response, such as the interplay between the human salience and
executive control networks [13], stress coping abilities, depression, anxiety,
psychological burden and long term stress exposure may constitute vulnerability
or resilience factors in relation to the peri-interventional stress response.
Background summary
Prostate cancer (PCa) is the most diagnosed non-skin cancer in men in the
Netherlands. Population aging and wider spread use of prostate-specific antigen
(PSA) screening tests are expected to further increase diagnosis of this
disease. In case of an elevated PSA, systematic transrectal ultrasound
(TRUS)-guided prostate biopsy is currently the standard technique to detect
PCa. However, as PSA is a non-specific marker for prostate cancer, urologists
are increasingly confronted with the dilemma of seeing patients with a high
clinical suspicion of PCa but negative initial TRUS-guided biopsy results. More
recently, the use of multi-parametric MR imaging has been well established in
detecting PCa, showing high localization accuracy. Consequently, MR imaging has
also been proposed in guiding biopsies towards cancer suspicious regions, with
the aim of improving diagnostic performance. MR-guided prostate biopsy is
routinely used in clinical practice at this institution Although MR imaging is
generally regarded as a safe diagnostic procedure, admission to the MR machine
in itself is a potential stressor, which coupled with the biopsy and threat of
cancer, may give rise to a strongly aversive and stressful subjective
experience.
Study objective
The purpose of our study is to assess the subjective stress response during MR
guided prostate biopsy and elucidate potential mediating influences of
cognitive and affective factors, long term stress exposure and stress-related
brain connectivity dynamics.
Study design
Prospective, non-randomized, single centre exploratory study. Within 2-3 days
prior to their medical intervention subjects will fill in 5 questionnaires
about their emotional well-being (~30 min) and one sheet about their medical
history. Prior to the biopsy they will get a 15 min. scan of the brain and
saliva and hair cortisol will be sampled, along with subjective ratings of the
affective state.
Study burden and risks
The routine clinical practice at the day of the intervention will be extended
by an additional MRI for which the patients will have to lie in a different
position. There are no elevated risks related to the additional MRI sequences
or the sampling of the saliva/hair or filling in of the questionnaires at home.
Reinier Postlaan 10
Nijmegen 6500 HB
NL
Reinier Postlaan 10
Nijmegen 6500 HB
NL
Listed location countries
Age
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.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL55573.091.15 |