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

NCT05779943 | Active Not Recruiting Phase 2 Results DMC FDA Drug

• 4 other identifiers: STUDY00004720RAD5689-22-BED-IIT-439NCI-2023-01322P30CA138292
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 4

Brief 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.

Conditions

Prostate Adenocarcinoma; Recurrent Prostate Carcinoma

Outcome Measures

Primary Outcomes (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).

  Up to 2 weeks

Secondary Outcomes (4)

• Change in Bladder and Renal Activity (Kidney SUV)

  Up to 2 weeks

• Change in Bladder and Renal Activity (Bladder Volume, ML)

  Up to 2 weeks

• Recurrent Disease Rate

  Up to 2 weeks

• Reader Confidence Score

  1 Month

Study Arms (1)

Treatment (furosemide, F-18 rhPSMA-7.3, PET-CT)

EXPERIMENTAL

Patients receive F-18 rhPSMA 7.3 tracer IV and then undergo PET-CT scans with and without furosemide IV on study.

Drug: Furosemide; Other: F18-rhPSMA-7.3; Procedure: Positron Emission Tomography; Procedure: Computed Tomography

Interventions

Furosemide DRUG

Given IV

Also known as: 54-31-9, FRS, Furosemide, FUROSEMIDE, Lasix, Lasix, LB 502, LB-502, LB-502, SK-Furosemide

Treatment (furosemide, F-18 rhPSMA-7.3, PET-CT)

F18-rhPSMA-7.3 OTHER

Given IV

Also known as: (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)

Treatment (furosemide, F-18 rhPSMA-7.3, PET-CT)

Positron Emission Tomography PROCEDURE

Undergo PET/CT scan

Also known as: Medical Imaging,Positron Emission Tomography, PET, PET SCAN

Treatment (furosemide, F-18 rhPSMA-7.3, PET-CT)

Computed Tomography PROCEDURE

Undergo PET/CT scan

Also known as: CAT, CAT Scan, CAT scan, CAT Scan,Computed Axial Tomography,Computed Tomography, Computerized Axial Tomography

Treatment (furosemide, F-18 rhPSMA-7.3, PET-CT)

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Emory University: lead
• National Cancer Institute (NCI): collaborator
• Blue Earth Diagnostics: collaborator

Study Sites (4)

Emory University Hospital Midtown

Atlanta, Georgia, 30308, United States

Location

Emory University Hospital/Winship Cancer Institute

Atlanta, Georgia, 30322, United States

Location

Emory Saint Joseph's Hospital

Atlanta, Georgia, 30342, United States

Location

Emory Johns Creek Hospital

Johns Creek, Georgia, 30097, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Furosemide; Magnetic Resonance Spectroscopy; X-Rays; 2-phenyl-6-(2'-(4'-(ethoxycarbonyl)thiazolyl))thiazolo(3,2-b)(1,2,4)triazole

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Sulfanilamides; Sulfonamides; Amides; Organic Chemicals; Aniline Compounds; Amines; Sulfones; Sulfur Compounds; Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques; Electromagnetic Radiation; Electromagnetic Phenomena; Magnetic Phenomena; Physical Phenomena; Radiation; Radiation, Ionizing

Results Point of Contact

• Title: Dr. David Schuster
• Organization: Emory University

dschust@emory.edu

4047781900

Study Officials

• Charles V. Marcus, MBBS

  Emory University Hospital/Winship Cancer Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 17, 2023
• First Posted: March 22, 2023
• Study Start: April 27, 2023
• Primary Completion: March 15, 2024
• Study Completion (Estimated): July 1, 2028
• Last Updated: October 27, 2025
• Results First Posted: October 27, 2025

Record last verified: 2025-10

Locations

US (4)