The ProCaRis Study: Prostate Cancer Risk Assessment in General Practice

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Prostate Cancer Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year–80 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Department of Molecular Medicine

Aarhus N, Aarhus, 8200, Denmark

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Genetic risk assessment

Genetic

Other names: Single nucleotide polymorphism

Primary outcomes

Number of low risk patients who get a PSA test

Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of Aarhus

Other

Collaborators

Aarhus University Hospital
Velux Fonden

Registry information

Official study title

Prostate Cancer Risk Assessment Using Genetic Markers in General Practice

Acronym: ProCaRis

Important dates

Study start: 2013
Primary completion: 2025
Study completion: 2031
First posted: Nov 30, 2012
Registry last updated: Dec 4, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Active, Not Recruiting