Ignite Creation Date:
2024-05-06 @ 2:15 PM
Last Modification Date:
2024-10-26 @ 1:28 PM
Study NCT ID:
NCT04264208
Status:
TERMINATED
Last Update Posted:
2024-02-01
First Post:
2020-02-04
Brief Title:
HDR Brachytherapy 68-Ga-RM2 PET 68-Ga-PSMA-11 PET Multi Parametric MRI in Prostate Cancer
Sponsor:
Andrei Iagaru
Organization:
Stanford University
Study Overview
Official Title:
Evaluation of Patients With Low-Risk and Intermediate-Risk Prostate Cancer Scheduled for High-Dose Rate Brachytherapy Using 68-Ga-RM2 PET 68Ga-PSMA-11 PET and Multi Parametric MRI
Status:
TERMINATED
Status Verified Date:
2024-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Lack of accrual due to pandemic and logistics
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study is being conducted to determine whether the combination of imaging agents 68-Ga RM2 and 68-Ga PMSA11 is better at assessing response to high dose rate HDR local therapy than standard imaging or biopsy in patients with known prostate cancer PC
Detailed Description:
Primary Objective
1 To demonstrate that 68Ga-RM2 and 68Ga-PSMA-11 PETMRI can detect additional cancers over mpMRI
2 To demonstrate that 68Ga-RM2 and 68Ga-PSMA-11 PETMRI can assess changes in response to treatment and predict progression free survival PFS at 24 months
1 To demonstrate that 68Ga-RM2 and 68Ga-PSMA-11 PETMRI can detect additional cancers over mpMRI
2 To demonstrate that 68Ga-RM2 and 68Ga-PSMA-11 PETMRI can assess changes in response to treatment and predict progression free survival PFS at 24 months
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
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 |
|---|---|---|---|
| 1R01CA230438 | NIH | CTRP | httpsreporternihgovquickSearch1R01CA230438 |
| PROS0098 | OTHER | None | None |
| NCI-2020-02779 | REGISTRY | None | None |