Ignite Creation Date:
2024-05-06 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 12:43 PM
Study NCT ID:
NCT03495427
Status:
RECRUITING
Last Update Posted:
2024-06-06
First Post:
2018-04-05
Brief Title:
PSMA-PET Imaging for Detecting Early Metastatic Prostate Cancer in Men w High Decipher Test Scores
Sponsor:
H Lee Moffitt Cancer Center and Research Institute
Organization:
H Lee Moffitt Cancer Center and Research Institute
Study Overview
Official Title:
The Utility of PSMA-PET Imaging for Detecting Early Metastatic Prostate Cancer in Men With High GC Decipher Test Scores A Sub-aim of the VANDAAM Study MCC 18523
Status:
RECRUITING
Status Verified Date:
2024-06
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:
None
Brief Summary:
This study will enroll 60 patients previously enrolled to MCC18523 A Validation Study on the Impact of Decipher Testing on Treatment Recommendations in African-American and Non-African American Men with Prostate Cancer VANDAAM that had high risk Decipher test results Decipher score 045 Patients with a high genomic classifier GC score at diagnosis will be approached for formal consenting for PSMA-PET imaging at 2 years post treatment
Detailed Description:
Normally some patients with prostate cancer undergo imaging tests to determine the extent spread of their disease These imaging tests often give good information but not in all patients and not every time This study deals with a new imaging test known as F-DCFPyL-Prostate-specific Membrane Antigen PSMA Positron Emission Tomography PET or F-DCFPyL-PSMA PET The objective of this study is to evaluate safety and usefulness of using F-DCFPyL in detecting recurrentmetastatic prostate cancer The F-DCFPyL PET imaging technique is used in some parts of the world but is not currently standard imaging care Better understanding how this new imaging test performs in identifying recurrentmetastatic prostate cancer may lead to better management of prostate cancer patients in the future
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