Character Traits and Stress in Suspected Prostate Cancer

Terminated

• Conditions: Prostatic Diseases

• Registration Number: NCT02031029
• Lead Sponsor: Helse Stavanger HF

Brief Summary

It has previously been reported that men with prostate cancer are 1 ) reduced quality of life after diagnosis and treatment, 2 ) neuroticism increases the reduction in QoL related to treatment side effects, and 3) often have very involved and active spouses who seems to have been handed over / taken over parts of the men's responsibility for their own health. We postulate herein a new hypothesis that the stress level is elevated when harbouring undetected prostate cancer. We will investigate whether those who are diagnosed with prostate cancer already in beforehand have an increased degree of masculine stress ( experience of not living up to their own perception of the ideal man ) and neuroticism in the typology. We will examine different personality and QoL questionnaires for patients with elevated PSA, and compare those whose clinical assessment later reveals prostate cancer, with three control groups: 1) men with elevated PSA who are not diagnosed with prostate cancer, 2) men with normal PSA treated for benign prostate enlargement and 3) patient with substantial risk of colorectal cancer (CRC) who undergo colonoscopy, with regard to increased level of masculine stress and the personality trait neuroticism.

Detailed Description

Inclusion criteria:

1. Men who are being referred as new urological outpatient and meet the following criteria:

1. Wanted clinical examined because of elevated PSA

2. Not strong family history of prostate cancer

3. It is taken biopsy as part of routine investigation.

2. Control groups: Men being referred to urological / gastroenterological outpatient clinic, and which meet the following criteria:

1. urination complaints, normal PSA, and study shows prostate size\> 40cc

2. Or melena and cancer suspicion in colorectum

3. Age\> 18 years and \<75 years

Outcome measures:

Together with statistician look for patterns / covariance in replies from those who are diagnosed with prostate cancer in the questionnaires personality evaluation adapted to normal population (Neo-FFI), gender differentiated stress response questionnaire (MGRSS) and questionnaires related to resilience, relationship and quality of life index, compared with the control groups.

Study Timeline

• Study First Submitted: 2013-10-09
• Study Start: 2013-12
• Study First Submitted QC: 2014-01-07
• Study First Posted: 2014-01-09
• Primary Completion: 2015-12-18
• Study Completion: 2015-12-18
• Status Verified: 2017-03
• Last Update Submitted: 2017-03-30
• Last Update Posted: 2017-03-31

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Male
• Target Recruitment: 51

Inclusion Criteria

1. Men who be referred a new urological outpatient and satisfy the following:

   • Wanted examined because of elevated PSA
   • Not strong family history of prostate cancer
   • It is taken biopsy as part of routine investigation.

2. Control group: Men referred to urological outpatient clinic, and who satisfy the following

   • urination complaints
   • Normal PSA
   • examination shows prostate size> 40cc

3. Control group: Men first time referred urological / gastroenterological outpatient clinic, and which satisfy the following

   -- symptoms that might indicate cancer suspicion in colorectum

4. Age> 40 years and <75 years

Exclusion criteria:

1. known prostate cancer
2. Reduced consent

4 Familial occurrence of prostate cancer (one or more 1st degree relatives with CaP)

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Cholesterol	2 years	Cholesterol at baseline and 2 years will be related to wether the patient has confirmed cancer or not.
Testosterone	2 years	Testosterone at baseline and 2 years will be related to wether the patient has confirmed cancer or not.
MGRSS questionnaire	2 years	The profile of the answering patterns will be compared to baseline using psychiatric and statistical evaluation.

Secondary Outcome Measures

Name	Time	Method
Vitamin D, Folic acid, White Blood Cells, C-reactive protein (CRP)	2 years	Blood values at baseline and 2 years will be related to wether the patient has confirmed cancer or not.
coffee and green tea consumption	2 years	The consumption of coffee and green tea will be related to wether the patient has confirmed cancer or not.

Trial Locations

Locations (2)

Akershus University Hospital; 🇳🇴 Lørenskog, Norway

Stavanger University Hospital, urological department; 🇳🇴 Stavanger, Norway