Ignite Creation Date:
2024-05-06 @ 7:35 AM
Last Modification Date:
2024-10-26 @ 11:50 AM
Study NCT ID:
NCT02564549
Status:
TERMINATED
Last Update Posted:
2017-10-19
First Post:
2015-09-28
Brief Title:
MRI-Based Active Surveillance to Avoid the Risks of Serial Biopsies in Men With Low-Risk Prostate Ca
Sponsor:
Virginia Commonwealth University
Organization:
Virginia Commonwealth University
Study Overview
Official Title:
Multiparametric MRI-Based Active Surveillance to Avoid the Risks of Serial Biopsies in Men With Low-Risk Prostate Cancer MAVERICK
Status:
TERMINATED
Status Verified Date:
2017-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Study halted prematurely and will not resume
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Phase II non-inferiority randomized trial of annual systematic biopsies versus mpMRI and targeted biopsies for men with low risk prostate cancer on active surveillance with any volume Gleasons Score 6 but no prior MRI imaging of the prostate
Detailed Description:
This is an unblinded randomized trial of TRUS biopsy-based active surveillance versus mpMRI-based active surveillance Patients on the TRUS biopsy-based arm will undergo annual systematic biopsies without any MRI staging or guidance Patients on the mpMRI- based arm will undergo annual mpMRI surveillance imaging with image-guided targeted biopsies only as indicated by radiographic findings
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 02147 | OTHER | Hunter Holmes McGuire VAMC | None |
| NCI-2015-01739 | REGISTRY | None | None |