The ProCaRis Study: Prostate Cancer Risk Assessment in General Practice

N/AActive Not RecruitingNCT01739062

University of Aarhus5,000 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SCREENING

Masking

NONE

Enrollment

5,000

Conditions

Prostate Cancer

Interventions

Eligibility

Sex: MALEMin age: 18 YearsMax age: 80 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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.

Time frame: 1 year, 2 years