Ignite Creation Date:
2025-12-25 @ 1:26 AM
Ignite Modification Date:
2026-02-25 @ 7:03 PM
Study NCT ID:
NCT03749993
Status:
COMPLETED
Last Update Posted:
2023-05-23
First Post:
2018-09-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of a MRI-based Prostate Cancer Screening Program
Sponsor:
University Hospital, Basel, Switzerland
Organization:
Study Overview
Official Title:
Evaluation of a MRI-based Prostate Cancer Screening Program
Status:
COMPLETED
Status Verified Date:
2023-05
Last Known Status:
None
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:
VISIONING
Brief Summary:
The purpose of this study is to evaluate the effort and resources (incl. costs) required to detect 20 clinically relevant prostate cancer (PCA) in a screening program based on bpMRI of the prostate.
Detailed Description:
Informed men at risk for prostate cancer will be included into the study to undergo prostate cancer screening. According to European guidelines we will include men \> 50 years of age and men \>45 years of age and a family history of PCA as well as African-Americans \>45 years of age. In this study, bpMRI will be used for opportunistic prostate cancer screening.
The indication for prostate biopsy is based solely on the results of bpMRI. In case of detection of lesions suspicious for prostate cancer ( PIRADS 3), targeted MRI-TRUS fusion biopsy with 3 biopsies per lesion will be performed. In case no lesions suspicious for PCA ( PIRADS 3) are detected, SB will performed if PSA exceeds 10ng/ml and/or DRE is suspicious for PCA.
The indication for prostate biopsy is based solely on the results of bpMRI. In case of detection of lesions suspicious for prostate cancer ( PIRADS 3), targeted MRI-TRUS fusion biopsy with 3 biopsies per lesion will be performed. In case no lesions suspicious for PCA ( PIRADS 3) are detected, SB will performed if PSA exceeds 10ng/ml and/or DRE is suspicious for PCA.
Study Oversight
Has Oversight DMC:
False
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?: