Trial Title:
Comparison of 18F-rhPSMA-7.3 PET/CT With and Without Furosemide in Biochemical Recurrence of Prostate Cancer
NCT ID:
NCT05779943
Condition:
Prostate Adenocarcinoma
Recurrent Prostate Carcinoma
Conditions: Official terms:
Recurrence
Furosemide
Fluorides
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Active, not recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Diagnostic
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Furosemide
Description:
Given IV
Arm group label:
Treatment (furosemide, F-18 rhPSMA-7.3, PET-CT)
Other name:
54-31-9, FRS, Furosemide, FUROSEMIDE, Lasix, Lasix, LB 502, LB-502, LB-502, SK-Furosemide
Intervention type:
Other
Intervention name:
F18-rhPSMA-7.3
Description:
Given IV
Arm group label:
Treatment (furosemide, F-18 rhPSMA-7.3, PET-CT)
Other name:
(18F)-rhPSMA-7.3,18F-rhPSMA-7.3,18FrhPSMA-7.3,2305081-64-3,F-18-rhPSMA-7.3,FLOTUFOLASTAT F-18, Fluorine F18 radiohybrid PSMA-7.3, Fluorine F18 rhPSMA-7.3, Fluorine-18 rhPSMA-7.3, rhPSMA-7.3(18F)
Intervention type:
Procedure
Intervention name:
Positron Emission Tomography
Description:
Undergo PET/CT scan
Arm group label:
Treatment (furosemide, F-18 rhPSMA-7.3, PET-CT)
Other name:
Medical Imaging,Positron Emission Tomography, PET, PET SCAN
Intervention type:
Procedure
Intervention name:
Computed Tomography
Description:
Undergo PET/CT scan
Arm group label:
Treatment (furosemide, F-18 rhPSMA-7.3, PET-CT)
Other name:
CAT, CAT Scan, CAT scan, CAT Scan,Computed Axial Tomography,Computed Tomography, Computerized Axial Tomography
Summary:
This phase II trial evaluates Fluorine-18 radiohybrid prostate-specific membrane antigen
(18F- rhPSMA)-7.3 positron emission tomography (PET)/computed 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 patient's body. Adding furosemide to
18F-rhPSMA 7.3 PET/CT 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-7.3 PET/CT 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-7.3 PET/CT with furosemide compared with 18F-rhPSMA-7.3 PET/CT without
furosemide.
OUTLINE:
Patients receive 18F-rhPSMA 7.3 tracer IV and then undergo PET-CT scans with and without
furosemide IV on study.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Adenocarcinoma of the prostate, post-prostatectomy
- Biochemical recurrence of prostate cancer following radical prostatectomy (RP) with
or without adjuvant or salvage therapy: PSA >= 0.2 ng/mL followed by a subsequent
confirmatory PSA value >= 0.2 ng/mL
- Age over 18
- Ability to provide written informed consent
- Patients with standard of care creatinine =< 1.3 mg/dL performed within 90 days
prior to enrollment
Exclusion Criteria:
- Inability to undergo 18F-rhPSMA PET-CT, contraindications to furosemide or urinary
incontinence
Gender:
Male
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Emory University Hospital Midtown
Address:
City:
Atlanta
Zip:
30308
Country:
United States
Facility:
Name:
Emory University Hospital/Winship Cancer Institute
Address:
City:
Atlanta
Zip:
30322
Country:
United States
Facility:
Name:
Emory Saint Joseph's Hospital
Address:
City:
Atlanta
Zip:
30342
Country:
United States
Facility:
Name:
Emory Johns Creek Hospital
Address:
City:
Johns Creek
Zip:
30097
Country:
United States
Start date:
April 27, 2023
Completion date:
July 1, 2028
Lead sponsor:
Agency:
Emory University
Agency class:
Other
Collaborator:
Agency:
National Cancer Institute (NCI)
Agency class:
NIH
Collaborator:
Agency:
Blue Earth Diagnostics
Agency class:
Industry
Source:
Emory University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05779943
