The ProCaRis Study: Prostate Cancer Risk Assessment in General Practice

NCT01739062 | Active Not Recruiting DMC

• 1 other identifier: 2011-41-6904
• Study Type: interventional
• Target: 5,000
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Number of low risk patients who get a PSA test

  The primary objective of this study is to evaluate the impact on use of PSA tests of introducing genetic PCa risk assessment in general practice.

  1 year, 2 years

Study Arms (2)

Genetic risk assessment

EXPERIMENTAL

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.

Genetic: Genetic risk assessment

Familial disposition risk assessment

NO INTERVENTION

Interventions

Genetic risk assessment GENETIC

Also known as: Single nucleotide polymorphism

Genetic risk assessment

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patients who receive a PSA test

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Aarhus: lead
• Velux Fonden: collaborator
• Aarhus University Hospital: collaborator

Study Sites (1)

Department of Molecular Medicine

Aarhus N, Aarhus, 8200, Denmark

Location

Related Publications (4)

• 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.

  PMID: 32457098 BACKGROUND

• 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.

  PMID: 32032355 BACKGROUND

• 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.

  PMID: 29454309 BACKGROUND

• 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.

  PMID: 23457331 DERIVED

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Polymorphism, Single Nucleotide

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Polymorphism, Genetic; Genetic Variation; Genetic Phenomena

Study Officials

• Karina D Sørensen, PhD

  Department of Molecular Medicine, Aarhus University Hospital, Denmark

  PRINCIPAL INVESTIGATOR

• Flemming Bro, Professor

  The Research Unit for General Practice, Aarhus University, Denmark

  STUDY CHAIR

• Peter Vedsted, Professor

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

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 27, 2012
• First Posted: November 30, 2012
• Study Start: February 1, 2013
• Primary Completion: October 30, 2025
• Study Completion (Estimated): October 30, 2031
• Last Updated: December 4, 2023

Record last verified: 2023-11

Locations

DK (1)