18F-rhPSMA-7.3 PET/CT Scans for Prostate Cancer Recurrence

Recruiting in Palo Alto (17 mi)

+3 other locations

Overseen byCharles V. Marcus, MBBS

Age: 18+

Sex: Male

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Emory University

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?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.

Eligibility Criteria

Men over 18 with prostate cancer that has returned after surgery, evidenced by rising PSA levels. They must be able to consent, have a specific type of prostate cancer (adenocarcinoma), and normal kidney function. Men who can't undergo PET-CT scans, have conditions preventing furosemide use or suffer from urinary incontinence cannot participate.

Inclusion Criteria

I am over 18 years old.

My latest kidney test shows creatinine levels at or below 1.3 mg/dL.

Ability to provide written informed consent

+2 more

Exclusion Criteria

I cannot take furosemide due to health reasons.

I experience involuntary loss of urine.

Inability to undergo 18F-rhPSMA PET-CT

Participant Groups

The trial is testing if using the diuretic furosemide alongside a PET/CT scan with a tracer called 18F-rhPSMA-7.3 improves detection of recurrent prostate cancer by reducing bladder radioactivity and enhancing image clarity.

1Treatment groups

Experimental Treatment

Group I: Treatment (furosemide, F-18 rhPSMA-7.3, PET-CT)Experimental Treatment4 Interventions

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

Computed Tomography is already approved in European Union, United States, Canada, Japan, China, Switzerland for the following indications:

🇪🇺 Approved in European Union as Computed Tomography for: