Trial Outcomes & Findings for Comparison of 18F-rhPSMA-7.3 PET/CT With and Without Furosemide in Biochemical Recurrence of Prostate Cancer (NCT NCT05779943)

Last Updated: 2025-10-27

Results Overview

Change in bladder SUV mean will be assessed using a paired t-test, or using a non-parametric equivalent such as a Wilcoxon signed rank test. Descriptively, change in bladder SUV mean will be reported for those administered 20 mg furosemide intravenously (IV) at the time of radiotracer injection first (group A), and those administered 20mg furosemide IV at the time of radiotracer injection second (group B).

Recruitment status

ACTIVE_NOT_RECRUITING

Study phase

PHASE2

Target enrollment

20 participants

Primary outcome timeframe

Up to 2 weeks

Results posted on

2025-10-27

Participant Flow

Participant milestones

Participant milestones
Measure	Group A - Complete 18F-rhPSMA-7.3 PET/CT #1 with furosemide followed by without furosemide . Patients receive F-18 rhPSMA 7.3 tracer IV and then undergo PET-CT scans with and without furosemide IV on study. Furosemide: Given IV F18-rhPSMA-7.3: Given IV Positron Emission Tomography: Undergo PET/CT scan Computed Tomography: Undergo PET/CT scan	Group B - Complete 18F-rhPSMA-7.3 PET/CT #1 without furosemide followed by with furosemide. Patients receive F-18 rhPSMA 7.3 tracer IV and then undergo PET-CT scans without and with furosemide IV on study. Furosemide: Given IV F18-rhPSMA-7.3: Given IV Positron Emission Tomography: Undergo PET/CT scan Computed Tomography: Undergo PET/CT scan
V1 (1-30 days after consent/screening) STARTED	10	10
V1 (1-30 days after consent/screening) COMPLETED	10	10
V1 (1-30 days after consent/screening) NOT COMPLETED	0	0
V2 (2-7days after PET/CT #1) STARTED	10	10
V2 (2-7days after PET/CT #1) COMPLETED	10	10
V2 (2-7days after PET/CT #1) NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Comparison of 18F-rhPSMA-7.3 PET/CT With and Without Furosemide in Biochemical Recurrence of Prostate Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Treatment (furosemide, F-18 rhPSMA-7.3, PET-CT) n=20 Participants Patients receive F-18 rhPSMA 7.3 tracer IV and then undergo PET-CT scans with and without furosemide IV on study. Furosemide: Given IV F18-rhPSMA-7.3: Given IV Positron Emission Tomography: Undergo PET/CT scan Computed Tomography: Undergo PET/CT scan
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	7 Participants n=5 Participants
Age, Categorical >=65 years	13 Participants n=5 Participants
Age, Continuous	67.95 Years STANDARD_DEVIATION 8.17 • n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	20 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	6 Participants n=5 Participants
Race (NIH/OMB) White	14 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	20 Participants n=5 Participants

PRIMARY outcome

Timeframe: Up to 2 weeks

Outcome measures

Outcome measures
Measure	Treatment (furosemide, F-18 rhPSMA-7.3, PET-CT) n=20 Participants Patients receive F-18 rhPSMA 7.3 tracer IV and then undergo PET-CT scans with and without furosemide IV on study. Furosemide: Given IV F18-rhPSMA-7.3: Given IV Positron Emission Tomography: Undergo PET/CT scan Computed Tomography: Undergo PET/CT scan	Without furosemide n=20 Participants Patients receive F-18 rhPSMA 7.3 tracer IV and then undergo PET-CT scans with and without furosemide IV on study. Furosemide: Given IV F18-rhPSMA-7.3: Given IV Positron Emission Tomography: Undergo PET/CT scan Computed Tomography: Undergo PET/CT scan
Change in Bladder Activity as Measured by Bladder Standardized Uptake Value (SUV) Mean	3.9 SUV Standard Deviation 3.71	20.64 SUV Standard Deviation 31.50

SECONDARY outcome

Timeframe: Up to 2 weeks

Kidney SUV - Change in bladder and renal activity will be assessed using paired t-tests, or using non-parametric equivalents such as a Wilcoxon signed rank tests. Descriptively, bladder and renal activity will be reported for those administered 20 mg furosemide IV at the time of radiotracer injection first (group A), and those administered 20 mg furosemide IV at the time of radiotracer injection second (group B).

Outcome measures

Outcome measures
Measure	Treatment (furosemide, F-18 rhPSMA-7.3, PET-CT) n=20 Participants Patients receive F-18 rhPSMA 7.3 tracer IV and then undergo PET-CT scans with and without furosemide IV on study. Furosemide: Given IV F18-rhPSMA-7.3: Given IV Positron Emission Tomography: Undergo PET/CT scan Computed Tomography: Undergo PET/CT scan	Without furosemide n=20 Participants Patients receive F-18 rhPSMA 7.3 tracer IV and then undergo PET-CT scans with and without furosemide IV on study. Furosemide: Given IV F18-rhPSMA-7.3: Given IV Positron Emission Tomography: Undergo PET/CT scan Computed Tomography: Undergo PET/CT scan
Change in Bladder and Renal Activity (Kidney SUV)	24.87 SUV Standard Deviation 7.95	27.12 SUV Standard Deviation 8.46

SECONDARY outcome

Timeframe: Up to 2 weeks

(Bladder Volume, ML) - Change in bladder and renal activity will be assessed using paired t-tests, or using non-parametric equivalents such as a Wilcoxon signed rank tests. Descriptively, bladder and renal activity will be reported for those administered 20 mg furosemide IV at the time of radiotracer injection first (group A), and those administered 20 mg furosemide IV at the time of radiotracer injection second (group B).

Outcome measures

Outcome measures
Measure	Treatment (furosemide, F-18 rhPSMA-7.3, PET-CT) n=20 Participants Patients receive F-18 rhPSMA 7.3 tracer IV and then undergo PET-CT scans with and without furosemide IV on study. Furosemide: Given IV F18-rhPSMA-7.3: Given IV Positron Emission Tomography: Undergo PET/CT scan Computed Tomography: Undergo PET/CT scan	Without furosemide n=20 Participants Patients receive F-18 rhPSMA 7.3 tracer IV and then undergo PET-CT scans with and without furosemide IV on study. Furosemide: Given IV F18-rhPSMA-7.3: Given IV Positron Emission Tomography: Undergo PET/CT scan Computed Tomography: Undergo PET/CT scan
Change in Bladder and Renal Activity (Bladder Volume, ML)	300.22 ML Standard Deviation 151.30	147.69 ML Standard Deviation 172.31

SECONDARY outcome

Timeframe: Up to 2 weeks

Defined as presence of unequivocal soft tissue radiotracer uptake that is characteristic of malignancy in the prostate bed and/or surrounding soft tissues and within pelvic lymph nodes. Recurrent disease rates will be compared (furosemide versus non-furosemide flotufolastat F-18 radiohybrid prostate-specific membrane antigen (18F-rhPSMA)-7.3 positron emission tomography (PET) scans using McNemar's tests. Rates will be reported, along with 95% exact confidence intervals using the Clopper-Pearson method. Descriptively, recurrent disease rate will be reported for those administered 20 mg furosemide IV at the time of radiotracer injection first (group A), and those administered 20 mg furosemide IV at the time of radiotracer injection second (group B).

Outcome measures

Outcome measures
Measure	Treatment (furosemide, F-18 rhPSMA-7.3, PET-CT) n=20 Participants Patients receive F-18 rhPSMA 7.3 tracer IV and then undergo PET-CT scans with and without furosemide IV on study. Furosemide: Given IV F18-rhPSMA-7.3: Given IV Positron Emission Tomography: Undergo PET/CT scan Computed Tomography: Undergo PET/CT scan	Without furosemide n=20 Participants Patients receive F-18 rhPSMA 7.3 tracer IV and then undergo PET-CT scans with and without furosemide IV on study. Furosemide: Given IV F18-rhPSMA-7.3: Given IV Positron Emission Tomography: Undergo PET/CT scan Computed Tomography: Undergo PET/CT scan
Recurrent Disease Rate Prostate bed - Negative (No recurrence detected)	3 Participants	8 Participants
Recurrent Disease Rate Prostate bed - Positive (Recurrence detected)	17 Participants	12 Participants
Recurrent Disease Rate Pelvic - Negative (No recurrence detected)	18 Participants	17 Participants
Recurrent Disease Rate Pelvic - Positive (Recurrence detected)	2 Participants	3 Participants
Recurrent Disease Rate Extra pelvic - Negative (No recurrence detected)	16 Participants	16 Participants
Recurrent Disease Rate Extra pelvic - Positive (Recurrence detected)	4 Participants	4 Participants
Recurrent Disease Rate Patient level - Negative (No recurrence detected)	2 Participants	5 Participants
Recurrent Disease Rate Patient level - Positive (Recurrence detected)	18 Participants	15 Participants

SECONDARY outcome

Timeframe: 1 Month

The readers' confidence in identifying prostate bed, pelvic and retroperitoneal nodal disease and other recurrence on 18F-rhPSMA-7.3 PET/computed tomography (CT) with furosemide compared with the 18F-rhPSMA-7.3 PET/CT without furosemide will be scored using a 5-point Likert scale ( 1 - Definitely benign, 2- probably benign, 3 - equivocal, 4 - probably malignant, 5 - definitely malignant). This analysis will be descriptive, with summary statistics reported with and without furosemide. Variables will be summarized using frequencies and percentages. In our analysis, 1,2 (no) will be considered benign while 3,4,5 malignant (yes). A high Likert score indicates that the reader is confident that the finding on the imaging is cancer (worse outcome), while a low score indicates no cancer (better outcome). All tests will be two-sided with an alpha level of 0.05, unless otherwise noted. Statistical analysis will be conducted using SAS 9.4.

Outcome measures

Outcome measures
Measure	Treatment (furosemide, F-18 rhPSMA-7.3, PET-CT) n=20 Participants Patients receive F-18 rhPSMA 7.3 tracer IV and then undergo PET-CT scans with and without furosemide IV on study. Furosemide: Given IV F18-rhPSMA-7.3: Given IV Positron Emission Tomography: Undergo PET/CT scan Computed Tomography: Undergo PET/CT scan	Without furosemide n=20 Participants Patients receive F-18 rhPSMA 7.3 tracer IV and then undergo PET-CT scans with and without furosemide IV on study. Furosemide: Given IV F18-rhPSMA-7.3: Given IV Positron Emission Tomography: Undergo PET/CT scan Computed Tomography: Undergo PET/CT scan
Reader Confidence Score Pelvis-Agree (Yes) (High Lickert Score 3-5)	19 participants	19 participants
Reader Confidence Score Pelvis-Agree (No) (Low Lickert Score 1-2)	1 participants	1 participants
Reader Confidence Score Extra-Prostate-Agree (Yes) (High Lickert Score 3-5)	15 participants	15 participants
Reader Confidence Score Extra-Prostate-Agree (No) (Low Lickert Score 1-2)	5 participants	5 participants
Reader Confidence Score Prostate Agree (Yes) (High Lickert Score 3-5)	10 participants	9 participants
Reader Confidence Score Prostate Agree (No) (Low Lickert Score 1-2)	10 participants	11 participants

Adverse Events

Complete 18F-rhPSMA-7.3 PET/CT #1 with furosemide Study Visit 1 (1-30 days after consent/screening)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Complete 18F-rhPSMA-7.3 PET/CT #1 without furosemide Study Visit 2 (2-7days after PET/CT #1)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Complete 18F-rhPSMA-7.3 PET/CT #1 without furosemide Visit 1 (1-30 days after consent/screening)

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Complete 18F-rhPSMA-7.3 PET/CT #1 with furosemide Study Visit 2 (2-7days after PET/CT #1)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Complete 18F-rhPSMA-7.3 PET/CT #1 with furosemide Study Visit 1 (1-30 days after consent/screening) n=10 participants at risk Patients receive F-18 rhPSMA 7.3 tracer IV and then undergo PET-CT scans with furosemide IV on study. Furosemide: Given IV F18-rhPSMA-7.3: Given IV Positron Emission Tomography: Undergo PET/CT scan Computed Tomography: Undergo PET/CT scan	Complete 18F-rhPSMA-7.3 PET/CT #1 without furosemide Study Visit 2 (2-7days after PET/CT #1) n=10 participants at risk Patients receive F-18 rhPSMA 7.3 tracer IV and then undergo PET-CT scans without furosemide IV on study. Furosemide: Given IV F18-rhPSMA-7.3: Given IV Positron Emission Tomography: Undergo PET/CT scan Computed Tomography: Undergo PET/CT scan	Complete 18F-rhPSMA-7.3 PET/CT #1 without furosemide Visit 1 (1-30 days after consent/screening) n=10 participants at risk Patients receive F-18 rhPSMA 7.3 tracer IV and then undergo PET-CT scans without furosemide IV on study. Furosemide: Given IV F18-rhPSMA-7.3: Given IV Positron Emission Tomography: Undergo PET/CT scan Computed Tomography: Undergo PET/CT scan	Complete 18F-rhPSMA-7.3 PET/CT #1 with furosemide Study Visit 2 (2-7days after PET/CT #1) n=10 participants at risk Patients receive F-18 rhPSMA 7.3 tracer IV and then undergo PET-CT scans with furosemide IV on study. Furosemide: Given IV F18-rhPSMA-7.3: Given IV Positron Emission Tomography: Undergo PET/CT scan Computed Tomography: Undergo PET/CT scan
General disorders Bruising at injection site	0.00% 0/10 • 1 month	0.00% 0/10 • 1 month	10.0% 1/10 • Number of events 1 • 1 month	0.00% 0/10 • 1 month

Additional Information

Dr. David Schuster

Emory University

Phone: 4047781900

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place