Ignite Creation Date:
2024-05-06 @ 11:07 AM
Last Modification Date:
2024-10-26 @ 12:40 PM
Study NCT ID:
NCT03431753
Status:
UNKNOWN
Last Update Posted:
2021-05-04
First Post:
2017-12-21
Brief Title:
Early and Accurate Detection of Prostate Cancer in General Practice
Sponsor:
Aarhus University Hospital
Organization:
University of Aarhus
Study Overview
Official Title:
Early and Accurate Detection of Prostate Cancer in General Practice Using Novel Molecular Biomarkers and Multiparametric MR Imaging
Status:
UNKNOWN
Status Verified Date:
2020-10
Last Known Status:
ENROLLING_BY_INVITATION
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Prostate cancer PC is the most common malignancy 4500 new casesyear and the second leading cause of cancer-associated mortality 1200 deathsyear among men in Denmark PC is generally diagnosed on the basis of an elevated prostate specific antigen blood test followed by transrectal ultrasound TRUS-guided prostate biopsy
This study aims to test early detection of PC in general practice using the STHLM3 model with superior specificity and sensitivity for clinically significant PC combined with multiparametric magnetic resonance imaging mpMRI of the prostate and MR guided biopsy
This study aims to test early detection of PC in general practice using the STHLM3 model with superior specificity and sensitivity for clinically significant PC combined with multiparametric magnetic resonance imaging mpMRI of the prostate and MR guided biopsy
Detailed Description:
While early stage PC can be cured by surgery or radiation therapy advanced PC is incurable and associated with high morbidity and mortality Early detection is critical to save lives but many newly diagnosed PCs are in reality non-aggressive and will not affect the patients life or health even if left untreated There is an urgent need to replace current clinical practice with a more accurate diagnostic approach that can ensure early detection of aggressive PC while curable reduce unnecessary prostate biopsies incl risk of sepsis and reduce overdiagnosis-treatment of indolent PC
New molecular biomarkers applied in general practice serving as a pre-selection test for follow-up and accurate and patient-friendly MR-imaging and MR-targeted biopsy at the hospital may help to solve these problems
In this study the investigators will assess the clinical utility of combining genetic risk testing and plasma protein markers STHLM3 test in general practice with mpMRI and MR-guided in bore biopsy MRGB for early PC detection in a biopsy naïve population
New molecular biomarkers applied in general practice serving as a pre-selection test for follow-up and accurate and patient-friendly MR-imaging and MR-targeted biopsy at the hospital may help to solve these problems
In this study the investigators will assess the clinical utility of combining genetic risk testing and plasma protein markers STHLM3 test in general practice with mpMRI and MR-guided in bore biopsy MRGB for early PC detection in a biopsy naïve population
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None