The ProCaRis Study: Prostate Cancer Risk Assessment in General Practice

Sponsor

University of Aarhus (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT01739062

Collaborator

Velux Fonden (Other), Aarhus University Hospital (Other)

5,000

Enrollment

Location

Arms

224.9

Anticipated Duration (Months)

22.2

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Prostate Cancer	Genetic: Genetic risk assessment	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

5000 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Screening

Official Title:

Prostate Cancer Risk Assessment Using Genetic Markers in General Practice

Actual Study Start Date :

Feb 1, 2013

Anticipated Primary Completion Date :

Oct 30, 2025

Anticipated Study Completion Date :

Oct 30, 2031

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	Genetic: Genetic risk assessment Other Names: Single nucleotide polymorphism
No Intervention: Familial disposition risk assessment

Arm

Intervention/Treatment

Experimental: 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.

Genetic: Genetic risk assessment

Other Names:

Single nucleotide polymorphism

No Intervention: Familial disposition risk assessment

Outcome Measures

Primary Outcome Measures

Number of low risk patients who get a PSA test [1 year, 2 years]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of Molecular Medicine	Aarhus N	Aarhus	Denmark	8200

Sponsors and Collaborators

University of Aarhus
Velux Fonden
Aarhus University Hospital

Investigators

Principal Investigator: Karina D Sørensen, PhD, Department of Molecular Medicine, Aarhus University Hospital, Denmark
Study Chair: 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 Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

University of Aarhus

ClinicalTrials.gov Identifier:

NCT01739062

Other Study ID Numbers:

2011-41-6904

First Posted:

Nov 30, 2012

Last Update Posted:

May 19, 2022

Last Verified:

May 1, 2022

Keywords provided by University of Aarhus

PSA test

Prostate cancer

Genetic screening

Additional relevant MeSH terms:

Prostatic Neoplasms

Study Results

No Results Posted as of May 19, 2022