Ignite Creation Date:
2024-05-06 @ 7:19 PM
Last Modification Date:
2024-10-26 @ 3:04 PM
Study NCT ID:
NCT05961514
Status:
RECRUITING
Last Update Posted:
2023-11-02
First Post:
2023-07-17
Brief Title:
the Beijing Randomized Study Of Prostate Cancer Screening
Sponsor:
Peking University Cancer Hospital Institute
Organization:
Peking University Cancer Hospital Institute
Study Overview
Official Title:
The Randomized Controlled Trial of Prostate Cancer Screening in Beijing China
Status:
RECRUITING
Status Verified Date:
2023-03
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:
BROPCS
Brief Summary:
BROPCS is a randomized trial study comparing the effectiveness of traditional systematic biopsies and bpMRI followed targeted biopsies with PSA 4ngml in initial screening
Detailed Description:
The aim of BROPCS study is to explore a suitable prostate cancer screening model for Chinese population which can increase the specificity in early detection of prostate cancer without decreasing the sensitivity of clinically significant prostate cancers and can reduce prostate cancer-specific mortalityThis study will use a cluster randomized controlled trial method with a total of approximately 30000 participants The subjects will be randomly assigned to a control group about 20000 people and a screening group about 10000 people and some basic information will be obtained through a questionnaire survey The screening group will undergo initial prostate-specific antigen PSA screening and high-risk subjects PSA 4ngml will be randomly assigned to two groups The standard biopsy group will undergo traditional systematic biopsy while the precision screening group will undergo further MRI examination and targeted fusion biopsy for those with positive MRI results
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