Ignite Creation Date:
2025-12-25 @ 5:11 AM
Ignite Modification Date:
2025-12-26 @ 4:16 AM
Study NCT ID:
NCT04240327
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-06-05
First Post:
2020-01-20
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Marker Driven Selection of Patients for Prostate Biopsy and Management
Sponsor:
University of Miami
Organization:
Study Overview
Official Title:
Marker Driven Selection of Patients for Prostate Biopsy and Management: The University of Miami MDSelect Protocol
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2025-06
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:
MDSelect
Brief Summary:
The purpose of this research study is to determine if the interpretation of multiparametric MRI (mpMRI) with an algorithm called habitat risk score (HRS) in combination with a panel of blood and urine biomarkers is more effective at detecting prostate cancer than standard of care interpretation of mpMRI with the Prostate Imaging Reporting and Data System (PIRADS).
Detailed Description:
None
Study Oversight
Has Oversight DMC:
True
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?:
False
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| U01CA239141-01A1 | NIH | None | https://reporter.nih.gov/quic… | View |
| NCI-2020-05157 | REGISTRY | NCI Clinical Trials Reporting Program (NCI CTRP) | View |