The ProCaRis Study: Prostate Cancer Risk Assessment in General Practice

University of Aarhus

Status: Active, not recruiting

Conditions: Prostate Cancer

Treatments: Genetic: Genetic risk assessment

Study type: Interventional

Funder types: Other

Identifiers

NCT01739062

2011-41-6904

Details and patient eligibility

About

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.

Enrollment: 5,000 patients

Sex: Male

Ages: 18 to 80 years old

Volunteers: Accepts 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

Trial design

Primary purpose: Screening

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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5,000 participants in 2 patient groups

Genetic risk assessment

Experimental group

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.

Treatment:

Genetic: Genetic risk assessment

Familial disposition risk assessment

No Intervention group