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

NCT ID: NCT05779943

Last Updated: 2025-10-27

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-04-27
• Study Completion Date: 2028-07-01

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.

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.

Conditions

Prostate Adenocarcinoma; Recurrent Prostate Carcinoma

Study Design

• Allocation Method: NA
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

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

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

Group Type: EXPERIMENTAL

Furosemide

Intervention Type: DRUG

Given IV

F18-rhPSMA-7.3

Intervention Type: OTHER

Given IV

Positron Emission Tomography

Intervention Type: PROCEDURE

Undergo PET/CT scan

Computed Tomography

Intervention Type: PROCEDURE

Undergo PET/CT scan

Interventions

Furosemide

Given IV

Intervention Type: DRUG

F18-rhPSMA-7.3

Given IV

Intervention Type: OTHER

Positron Emission Tomography

Undergo PET/CT scan

Intervention Type: PROCEDURE

Computed Tomography

Undergo PET/CT scan

Intervention Type: PROCEDURE

Other Intervention Names

54-31-9, FRS, Furosemide, FUROSEMIDE, Lasix, Lasix, LB 502, LB-502, LB-502, SK-Furosemide; (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); Medical Imaging,Positron Emission Tomography, PET, PET SCAN; CAT, CAT Scan, CAT scan, CAT Scan,Computed Axial Tomography,Computed Tomography, Computerized Axial Tomography

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Blue Earth Diagnostics

INDUSTRY

Sponsor Role: collaborator

Emory University

OTHER

Sponsor Role: lead

Responsible Party

David M Schuster

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Charles V. Marcus, MBBS

Role: PRINCIPAL_INVESTIGATOR

Emory University Hospital/Winship Cancer Institute

Locations

Emory University Hospital Midtown

Atlanta, Georgia, United States

Emory University Hospital/Winship Cancer Institute

Atlanta, Georgia, United States

Emory Saint Joseph's Hospital

Atlanta, Georgia, United States

Emory Johns Creek Hospital

Johns Creek, Georgia, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

RAD5689-22-BED-IIT-439

Identifier Type: OTHER

Identifier Source: secondary_id

STUDY00004720

Identifier Type: OTHER

Identifier Source: secondary_id

NCI-2023-01322

Identifier Type: REGISTRY

Identifier Source: secondary_id

P30CA138292

Identifier Type: NIH

Identifier Source: secondary_id

View Link

STUDY00004720

Identifier Type: -

Identifier Source: org_study_id