Ignite Creation Date:
2024-05-06 @ 6:45 PM
Last Modification Date:
2024-10-26 @ 2:54 PM
Study NCT ID:
NCT05779943
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-07-03
First Post:
2023-02-17
Brief Title:
Comparison of 18F-rhPSMA-73 PETCT With and Without Furosemide in Biochemical Recurrence of Prostate Cancer
Sponsor:
Emory University
Organization:
Emory University
Study Overview
Official Title:
Strategy to Reduce Bladder Activity With RhPSMA 73 Comparison of 18F-RhPSMA 73 PETCT With and Without Furosemide in Biochemical Recurrence of Prostate Cancer
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-07
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:
This phase II trial evaluates Fluorine-18 radiohybrid prostate-specific membrane antigen 18F- rhPSMA-73 positron emission tomography PETcomputed tomography CT scans with and without furosemide for the reduction of bladder activity in patients with prostate cancer that has come back recurrent based on elevated levels of prostate-specific antigen PSA in the blood biochemical after prostate surgery prostatectomy Furosemide is a diuretic substance that increases the urine flow into the bladder thereby decreasing the level of radioactivity within the bladder which may help to see any abnormal areas that could be masked by the radioactivity within the bladder PET is an established imaging technique that utilizes small amounts of radioactivity attached to very minimal amounts of tracer in the case of this research rhPSMA ligand CT utilizes x-rays that traverse body from the outside CT images provide an exact outline of organs and potential inflammatory tissue where it occurs in patients body Adding furosemide to 18F-rhPSMA 73 PETCT scans may help to better detect and treat patients with biochemically recurrent prostate cancer
Detailed Description:
PRIMARY OBJECTIVE
I To determine if administering 20 mg furosemide intravenously IV at the time of radiotracer injection significantly reduces bladder activity compared with the same patient scanned without furosemide as internal control
SECONDARY OBJECTIVES
I To compare detection rates of recurrent disease in blinded interpretations between the furosemide and non-furosemide 18FrhPSMA-73 PETCT scans with patients serving as their own internal controls
II To compare reader confidence in identifying prostate bed and other recurrent lesions on a 18F-rhPSMA-73 PETCT with furosemide compared with 18F-rhPSMA-73 PETCT without furosemide
OUTLINE
Patients receive 18F-rhPSMA 73 tracer IV and then undergo PET-CT scans with and without furosemide IV on study
I To determine if administering 20 mg furosemide intravenously IV at the time of radiotracer injection significantly reduces bladder activity compared with the same patient scanned without furosemide as internal control
SECONDARY OBJECTIVES
I To compare detection rates of recurrent disease in blinded interpretations between the furosemide and non-furosemide 18FrhPSMA-73 PETCT scans with patients serving as their own internal controls
II To compare reader confidence in identifying prostate bed and other recurrent lesions on a 18F-rhPSMA-73 PETCT with furosemide compared with 18F-rhPSMA-73 PETCT without furosemide
OUTLINE
Patients receive 18F-rhPSMA 73 tracer IV and then undergo PET-CT scans with and without furosemide IV on study
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 |
|---|---|---|---|
| RAD5689-22-BED-IIT-439 | OTHER | None | None |
| P30CA138292 | NIH | CTRP Clinical Trial Reporting Program | httpsreporternihgovquickSearchP30CA138292 |
| STUDY00004720 | OTHER | None | None |
| NCI-2023-01322 | REGISTRY | None | None |