The ProCaRis Study: Prostate Cancer Risk Assessment in General Practice

Prostate Cancer Clinical Trial

— ProCaRis  

Official title:

Prostate Cancer Risk Assessment Using Genetic Markers in General Practice

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01739062
• Other study ID #: 2011-41-6904
• Status: Active, not recruiting
• Phase: N/A
• Start date: February 2013
• Est. completion date: October 30, 2031

Study information

• Verified date: November 2023
• Source: University of Aarhus
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 5000
• Est. completion date: October 30, 2031
• Est. primary completion date: October 30, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Genetic:
• Genetic risk assessment

Locations

Country	Name	City	State
Denmark	Department of Molecular Medicine	Aarhus N	Aarhus

Sponsors (3)

Lead Sponsor	Collaborator
University of Aarhus	Aarhus University Hospital, Velux Fonden

Country where clinical trial is conducted

Denmark, 

References & Publications (3)

Fredsoe J, Kirkegaard P, Edwards A, Vedsted P, Sorensen KD, Bro F. A genetic risk assessment for prostate cancer influences patients' risk perception and use of repeat PSA testing: a cross-sectional study in Danish general practice. BJGP Open. 2020 Jun 23;4(2):bjgpopen20X101039. doi: 10.3399/bjgpopen20X101039. Print 2020. — View 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. — View Citation

Kirkegaard P, Edwards A, Nielsen TLO, Orntoft TF, Sorensen KD, Borre M, Bro F. Perceptions about screening for prostate cancer using genetic lifetime risk assessment: a qualitative study. BMC Fam Pract. 2018 Feb 17;19(1):32. doi: 10.1186/s12875-018-0717-6. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	1 year, 2 years