Clinical trial NCT01739062: The ProCaRis Study: Prostate Cancer Risk Assessment in General Practice
Official title: Prostate Cancer Risk Assessment Using Genetic Markers in General Practice
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Prostate Cancer
Keywords: PSA test
Prostate cancer
Genetic screening
Lead sponsor: University of Aarhus
Sponsor class: OTHER
Collaborators: name: Velux Fonden
name: Aarhus University Hospital
First posted: 2012-11-30
Enrollment: 5000
Sex: MALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief summary: The preferred method for early detection of prostate cancer (PCa) in older men with family history is the Prostate Specific Antigen test (PSA test), although the method is imprecise. It produces a high number of false-positive results and increases the risk of over-diagnosis and over-treatment. Yet, an increasing number of men get the PSA test as part of unsystematic screening. Genetic risk assessment may be a better way to identify men with low risk of PCa. The main study hypothesis is that genetic information about low risk of PCa can reduce the number of patients who get a PSA test as part of unsystematic screening.


Eligibility criteria: Inclusion Criteria:

* patients who receive a PSA test

Exclusion Criteria:

* age over 80 years
* elevated PSA-level (\> 4,0 ng/ml) concurrently or within previous 2 years
* prostate or bladder disease
* prostate cancer
* non-Caucasians
* do not speak and understand Danish

Primary outcomes:
measure: Number of low risk patients who get a PSA test
timeFrame: 1 year, 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Aarhus N
country: Denmark
facility: Department of Molecular Medicine
state: Aarhus
Study officials:
affiliation: Department of Molecular Medicine, Aarhus University Hospital, Denmark
name: Karina D Sørensen, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: The Research Unit for General Practice, Aarhus University, Denmark
name: Flemming Bro, Professor
role: STUDY_CHAIR
affiliation: Danish Research Centre for Cancer Diagnosis in Primary Care, Aarhus University, Denmark
name: Peter Vedsted, Professor
role: STUDY_CHAIR
References:
citation: Fredsoe J, Kirkegaard P, Edwards A, Vedsted P, Sorensen KD, Bro F. A genetic risk assessment for prostate cancer influences patients' risk perception and use of repeat PSA testing: a cross-sectional study in Danish general practice. BJGP Open. 2020 Jun 23;4(2):bjgpopen20X101039. doi: 10.3399/bjgpopen20X101039. Print 2020.
citation: Fredsoe J, Koetsenruyter J, Vedsted P, Kirkegaard P, Vaeth M, Edwards A, Orntoft TF, Sorensen KD, Bro F. The effect of assessing genetic risk of prostate cancer on the use of PSA tests in primary care: A cluster randomized controlled trial. PLoS Med. 2020 Feb 7;17(2):e1003033. doi: 10.1371/journal.pmed.1003033. eCollection 2020 Feb.
citation: Kirkegaard P, Edwards A, Nielsen TLO, Orntoft TF, Sorensen KD, Borre M, Bro F. Perceptions about screening for prostate cancer using genetic lifetime risk assessment: a qualitative study. BMC Fam Pract. 2018 Feb 17;19(1):32. doi: 10.1186/s12875-018-0717-6.
citation: Kirkegaard P, Vedsted P, Edwards A, Fenger-Gron M, Bro F. A cluster-randomised, parallel group, controlled intervention study of genetic prostate cancer risk assessment and use of PSA tests in general practice--the ProCaRis study: study protocol. BMJ Open. 2013 Mar 1;3(3):e002452. doi: 10.1136/bmjopen-2012-002452.