The ProCaRis Study: Prostate Cancer Risk Assessment in General Practice

NCT ID: NCT01739062

Last Updated: 2023-12-04

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 5000 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-02-28
• Study Completion Date: 2031-10-30

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.

Conditions

Prostate Cancer

Keywords

PSA test; Prostate cancer; Genetic screening

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SCREENING
• Blinding Strategy: NONE

Study Groups

Genetic risk assessment

At least 40 SNP (single nucleotide polymorphisms)increase the risk of PCa. The individual risk of PCa accumulates with the increasing number of these genetic variants. The risk is doubled if patient has familial disposition as well. In retrospective studies, non-genetic risk-prediction models were compared to risk-prediction models containing both non-genetic factors and SNPs analyses. The genetic models had a significantly higher specificity than the non-genetic models. It has been argued that genetic PCa risk assessment could reduce the inexpedient use of PSA tests, saving it for patients at high risk of PCa.

Group Type: EXPERIMENTAL

Genetic risk assessment

Intervention Type: GENETIC

Familial disposition risk assessment

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Genetic risk assessment

Intervention Type: GENETIC

Other Intervention Names

Single nucleotide polymorphism

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Velux Fonden

OTHER

Sponsor Role: collaborator

Aarhus University Hospital

OTHER

Sponsor Role: collaborator

University of Aarhus

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Karina D Sørensen, PhD

Role: PRINCIPAL_INVESTIGATOR

Department of Molecular Medicine, Aarhus University Hospital, Denmark

Flemming Bro, Professor

Role: STUDY_CHAIR

The Research Unit for General Practice, Aarhus University, Denmark

Peter Vedsted, Professor

Role: STUDY_CHAIR

Danish Research Centre for Cancer Diagnosis in Primary Care, Aarhus University, Denmark

Locations

Department of Molecular Medicine

Aarhus N, Aarhus, Denmark

Countries

Denmark

References

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.

Reference Type: BACKGROUND

PMID: 32457098 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 32032355 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 29454309 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 23457331 (View on PubMed)

Other Identifiers

2011-41-6904

Identifier Type: -

Identifier Source: org_study_id