- Recruiting
- Prevention
- Interventional
- Diagnostic Test & Procedure
- Masaryk Memorial Cancer Institute
- 50 - 69 Years
Study Purpose
Prostate cancer is one of the most common malignancies in the male population with incidence and mortality rates comparable to breast cancer in women, but in contrast, a population screening program that would fulfill all the recommended criteria is not yet available. According to international recommendations, the preventive PSA sampling used in clinical practice is not suitable because of the concurrent detection of clinically insignificant carcinomas in a major proportion of tests. These clinically non-significant cancers make up a significant and increasing proportion with age. Detection of non-significant cancers burdens the health care system and patients with the care that has no positive impact on their health. Current preventive serum prostate-specific antigen (PSA) testing does not distinguish benign hyperplasia and nonsignificant carcinoma from clinically significant cancer. It is therefore not suitable for full-scale screening. According to current guidelines, magnetic resonance imaging (MRI) is indicated only in patients with an increased risk of cancer for detection or staging after biopsy and is not used for screening. According to recent studies, MRI has detected an increased proportion of significant cancers in the general population compared to screening based on PSA, while fewer clinically insignificant cancers have been detected. In screening, a shorter examination protocol without contrast medium (biparametric MRI) is used with a lower cost per examination, allowing to increase both the number of patients examined and patient comfort. The main objective of the project is to assess the contribution of imaging in the screening of clinically significant prostate cancer and to validate the published results in the Czech population, and extend the screening model by the second round of examinations and additional laboratory markers. The secondary aim is to design a subsequent study with a larger number of participants allowing statistical evaluation, similar to the successful breast cancer screening.
Intervention
Diagnostic Test : magnetic resonance
Diagnostic Test : serum PSA examination
Procedure : Biopsy
Eligibility Requirements
Age 50-69 years
Life expectancy over 10 years
Ability to undergo all planned procedures (without contraindications to MRI or biopsy)
No known prostate cancer or prostate biopsy in the past (interventions for BPH are not a restriction)
No PSA test or prostate MRI in the past 2 years.
No signs of prostatitis or urinary tract infection in the past 6 months.
Signed informed consent.
Contraindications to MRI
Hip replacement
Known BRCA1/BRCA2 mutation
Recruiting status
Recruiting
Estimated enrollment
300
Study start date
May 01, 2022
Study end date
Dec 31, 2025
Last updated
Mar 22, 2025
Primary purpose
Prevention
Design
Interventional
Intervention
Diagnostic Test & Procedure
Study phase
NA
Allocation
Na
Sponsor:
Masaryk Memorial Cancer Institute
Collaborator:
Masaryk University
Investigator:
Michal StanĂk, MD,PhD.
NCT05603351
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