Ignite Creation Date:
2024-05-06 @ 8:03 PM
Last Modification Date:
2024-10-26 @ 3:19 PM
Study NCT ID:
NCT06238661
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-02
First Post:
2024-01-25
Brief Title:
Prostate Cancer Screening a Pilot Study
Sponsor:
Fondazione del Piemonte per lOncologia
Organization:
Fondazione del Piemonte per lOncologia
Study Overview
Official Title:
Prostate Cancer Screening With PSA Risk Calculator and Multiparametric MRI a Pilot Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-03
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:
ProScreenMRI
Brief Summary:
Prostate Cancer PCa is the second most frequently diagnosed tumour and the third most lethal among men in Europe The lack of precise tools and examinations to precisely diagnose PCa has caused overtreatment of indolent and low-aggressive PCa while in some other cases with aggressive disease diagnosis and treatment are dangerously delayed because cancer could be potentially missed The present trial aims to study a new pathway to early diagnose PCa with Magnetic Resonance Imaging MRI to identify men who will not need treatment and those who will benefit from radical treatment thus improving disease control and quality of life
Detailed Description:
Men aged 55-65 years with neither previous biopsy nor prostate diseases will be invited in the screening protocol and will perform an initial PSA test Those cases with PSA 3 ngml will be invited to undergo a urologic examination with computed risk assessment and an MRI which is a non-invasive test with high positive and negative predictive value in identifying clinically significant prostate cancer Then only men with medium-high risk of harbouring clinically significant prostate cancer will be invited to undergo a prostate biopsy to indentify cancer presence and its aggressiveness
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