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The ProCaRis Study: Prostate Cancer Risk Assessment in General Practice (ProCaRis)

Primary Purpose

Prostate Cancer

Status
Active
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Genetic risk assessment
Sponsored by
University of Aarhus
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Prostate Cancer focused on measuring PSA test, Prostate cancer, Genetic screening

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)MaleAccepts Healthy Volunteers

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

Sites / Locations

  • Department of Molecular Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Genetic risk assessment

Familial disposition risk assessment

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
November 27, 2012
Last Updated
May 18, 2022
Sponsor
University of Aarhus
Collaborators
Velux Fonden, Aarhus University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01739062
Brief Title
The ProCaRis Study: Prostate Cancer Risk Assessment in General Practice
Acronym
ProCaRis
Official Title
Prostate Cancer Risk Assessment Using Genetic Markers in General Practice
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
February 2013 (Actual)
Primary Completion Date
October 30, 2025 (Anticipated)
Study Completion Date
October 30, 2031 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Aarhus
Collaborators
Velux Fonden, Aarhus University Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
PSA test, Prostate cancer, Genetic screening

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
5000 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Genetic risk assessment
Arm Type
Experimental
Arm Description
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.
Arm Title
Familial disposition risk assessment
Arm Type
No Intervention
Intervention Type
Genetic
Intervention Name(s)
Genetic risk assessment
Other Intervention Name(s)
Single nucleotide polymorphism
Primary Outcome Measure Information:
Title
Number of low risk patients who get a PSA test
Description
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.
Time Frame
1 year, 2 years

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Karina D Sørensen, PhD
Organizational Affiliation
Department of Molecular Medicine, Aarhus University Hospital, Denmark
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Flemming Bro, Professor
Organizational Affiliation
The Research Unit for General Practice, Aarhus University, Denmark
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Peter Vedsted, Professor
Organizational Affiliation
Danish Research Centre for Cancer Diagnosis in Primary Care, Aarhus University, Denmark
Official's Role
Study Chair
Facility Information:
Facility Name
Department of Molecular Medicine
City
Aarhus N
State/Province
Aarhus
ZIP/Postal Code
8200
Country
Denmark

12. IPD Sharing Statement

Citations:
PubMed Identifier
32032355
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.
Results Reference
derived
PubMed Identifier
23457331
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.
Results Reference
derived

Learn more about this trial

The ProCaRis Study: Prostate Cancer Risk Assessment in General Practice

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