Ignite Creation Date:
2024-10-26 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06617481
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-09-25
Brief Title:
PET Scan Study to Detect Prostate Cancer in Patients with Early PSA Recurrence
Sponsor:
None
Organization:
None
Study Overview
Official Title:
RhPSMA-7318F-PET Scan to Detect Prostate Cancer in Patients with Early PSA Recurrence
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Flotufolastat F-18 sold under the brand name Posluma is a radioactive diagnostic agent for use with positron emission tomography PET imaging for prostate cancer
The research is being done to study the capability of 18F-rhPSMA-73 flotufolastat F-18 PET scan to detect prostate cancer when there are very low levels of Prostate-Specific Antigen PSA following previous radical prostatectomy surgery
The research is being done to study the capability of 18F-rhPSMA-73 flotufolastat F-18 PET scan to detect prostate cancer when there are very low levels of Prostate-Specific Antigen PSA following previous radical prostatectomy surgery
Detailed Description:
This is not an investigational study drug Flotufolastat PET scan is FDA Approved for positron emission tomography PET of prostate-specific membrane antigen PSMA positive lesions in men with prostate cancer with suspected metastasis who are candidates for initial definitive therapy and those with suspected recurrence based on elevated serum prostate-specific antigen PSA level In this research study the flotufolastat-PET scan will be repeated if the initial scan does not show cancer and if PSA further rises by greater than 01 ngml Other currently used scans for this purpose do not detect cancer in all patients with low levels of rising PSA
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None