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Prostate AdenocarcinomaPhase 2NCT05779943

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

A Phase 2 study testing Furosemide, F18-rhPSMA-7.3 and Positron Emission Tomography in people with Prostate Adenocarcinoma and Recurrent Prostate Carcinoma, run by Emory University at 4 sites in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older, men only
What is being tested?
Furosemide, F18-rhPSMA-7.3 and Positron Emission Tomography
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
4 sitesUnited States
Study dates
27 Apr 2023to 1 Jul 2028
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • Inability to undergo 18F-rhPSMA PET-CT, contraindications to furosemide or urinary incontinence

Trial locations and contacts

4 sites in 1 country.

United States4 sites

  • Emory University Hospital Midtown

    Atlanta, Georgia, 30308

  • Emory University Hospital/Winship Cancer Institute

    Atlanta, Georgia, 30322

  • Emory Saint Joseph's Hospital

    Atlanta, Georgia, 30342

  • Emory Johns Creek Hospital

    Johns Creek, Georgia, 30097

Other trials in United States

About this study

Official title: Strategy to Reduce Bladder Activity With RhPSMA 7.3: Comparison of 18F-RhPSMA 7.3 PET/CT With and Without Furosemide in Biochemical Recurrence of Prostate Cancer

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.

Read the detailed description

PRIMARY OBJECTIVE:

  1. 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:

  1. 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.

Being tested
Furosemide, F18-rhPSMA-7.3, Positron Emission Tomography, Computed Tomography
Medical subject headings
Prostatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • FurosemideDrug

    Also called 54-31-9, FRS, Furosemide, FUROSEMIDE, Lasix, Lasix, LB 502, LB-502, LB-502, SK-Furosemide

    Given IV

  • F18-rhPSMA-7.3Other

    Also called (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)

    Given IV

  • Positron Emission TomographyProcedure or surgery

    Also called Medical Imaging,Positron Emission Tomography, PET, PET SCAN

    Undergo PET/CT scan

  • Computed TomographyProcedure or surgery

    Also called CAT, CAT Scan, CAT scan, CAT Scan,Computed Axial Tomography,Computed Tomography, Computerized Axial Tomography

    Undergo PET/CT scan

Study groups in NCT05779943
Study groupRoleWhat they receive
Treatment (furosemide, F-18 rhPSMA-7.3, PET-CT)ExperimentalPatients receive F-18 rhPSMA 7.3 tracer IV and then undergo PET-CT scans with and without furosemide IV on study.
Receives: Drug: Furosemide; Other: F18-rhPSMA-7.3; Procedure: Positron Emission Tomography; Procedure: Computed Tomography

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Bladder Activity as Measured by Bladder Standardized Uptake Value (SUV) Mean

    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).

    Measured: Up to 2 weeks

Secondary outcomes (4)

  1. Change in Bladder and Renal Activity (Kidney SUV)

    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).

    Measured: Up to 2 weeks

  2. Change in Bladder and Renal Activity (Bladder Volume, ML)

    (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).

    Measured: Up to 2 weeks

  3. Recurrent Disease Rate

    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).

    Measured: Up to 2 weeks

  4. Reader Confidence Score

    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.

    Measured: 1 Month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Mar 2023
  2. Study start27 Apr 2023
  3. Primary completion15 Mar 2024
  4. Study completion1 Jul 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Diagnosis
Allocation
Not applicable
Intervention model
Sequential
Masking
None (open label)
Enrolment
20 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05779943
Sponsor's protocol ID
STUDY00004720
Other IDs
RAD5689-22-BED-IIT-439, STUDY00004720, NCI-2023-01322, P30CA138292
Status last verified
Oct 2026
First submitted
17 Feb 2023
Last updated
4 Nov 2026
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • Lawal IO, Mushtaq A, Jani AB, Rupji M, Dhere VR, Patel SA, Bilen MA, Patel PR, Sebastian NT, Switchenko JM, Schuster DM, Marcus C. Diuresis During 18F-Flotufolastat (rhPSMA-7.3) PET/CT Improves Recurrence Detection After Prostatectomy: A Prospective Phase II Trial. J Nucl Med. 2025 Feb 3;66(2):230-237. doi: 10.2967/jnumed.124.268574.

    PubMed 39848765

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Furosemide, F18-rhPSMA-7.3 and Positron Emission Tomography in people with Prostate Adenocarcinoma and Recurrent Prostate Carcinoma, run by Emory University at 4 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 4 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 27 Oct 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Bladder Activity as Measured by Bladder Standardized Uptake Value (SUV) Mean (time frame: Up to 2 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05779943, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2026.

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