The ProCaRis Study: Prostate Cancer Risk Assessment in General Practice

NCT01739062 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 5000

Last updated 2023-12-04

No results posted yet for this study

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.

Conditions

Interventions

GENETIC

Genetic risk assessment

Sponsors & Collaborators

  • Velux Fonden

    collaborator OTHER
  • Aarhus University Hospital

    collaborator OTHER
  • University of Aarhus

    lead OTHER

Principal Investigators

  • Karina D Sørensen, PhD · Department of Molecular Medicine, Aarhus University Hospital, Denmark

  • Flemming Bro, Professor · The Research Unit for General Practice, Aarhus University, Denmark

  • Peter Vedsted, Professor · Danish Research Centre for Cancer Diagnosis in Primary Care, Aarhus University, Denmark

Study Design

Allocation
RANDOMIZED
Purpose
SCREENING
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2013-02-28
Primary Completion
2025-10-30
Completion
2031-10-30

Countries

  • Denmark

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01739062 on ClinicalTrials.gov