An Investigational Scan (18F-rhPSMA 7.3 PET/CT) with and without Furosemide for the Reduction of Bladder Activity in Patients with Biochemically Recurrent Prostate Cancer

Active:	Yes
Cancer Type:	Prostate Cancer	NCT ID:	NCT05779943
Trial Phases:	Phase II	Protocol IDs:	RAD5689-22-BED-IIT-439 (primary) NCI-2023-01322 STUDY00004720
Eligibility:	18 Years and older, Male	Study Type:	Diagnostic
Study Sponsor:	Emory University Hospital/Winship Cancer Institute
NCI Full Details:	http://clinicaltrials.gov/show/NCT05779943

Summary

This phase II trial evaluates flotufolastat F-18 gallium 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.

Objectives

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 flotufolastat F-18 gallium tracer IV and then undergo PET-CT scans with and without furosemide IV 60-70 minutes post-injection.

Patients are followed up at 1-3 days after each PET/CT.

Treatment Sites in Georgia

Emory Johns Creek Hospital
6325 Hospital Parkway
Johns Creek, GA 30097
www.emoryjohnscreek.com

Emory Saint Joseph's Hospital
5665 Peachtree Dunwoody Road NE
Atlanta, GA 30342
www.emoryhealthcare.org

Emory University Hospital - Midtown
550 Peachtree Street NE
Atlanta, GA 30308
404-686-4411
www.emoryhealthcare.org

Winship Cancer Institute of Emory University
1365 Clifton Road NE
Building C
Atlanta, GA 30322
winshipcancer.emory.edu

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