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

Phase 2
Waitlist Available
Led By Charles V. Marcus, MBBS
Research Sponsored by Emory University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 4 years
Awards & highlights
No Placebo-Only Group

Summary

This trial tests using PET/CT scans with and without furosemide to detect prostate cancer recurrence in patients who have had surgery.

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Potential side effects include those related to furosemide such as increased urination, dehydration, electrolyte imbalance; and general risks associated with PET/CT scans like exposure to low-level radiation.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 4 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 4 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in bladder activity as measured by bladder standardized uptake value (SUV) mean
Secondary study objectives
Change in bladder and renal activity
Reader confidence score
Recurrent disease rate

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Positron Emission Tomography
2011
Completed Phase 2
~2200
Computed Tomography
2017
Completed Phase 2
~2740
Furosemide
2015
Completed Phase 4
~4240

Find a Location

Who is running the clinical trial?

Emory UniversityLead Sponsor
1,697 Previous Clinical Trials
2,603,798 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,925 Previous Clinical Trials
41,017,981 Total Patients Enrolled
Blue Earth DiagnosticsIndustry Sponsor
41 Previous Clinical Trials
3,042 Total Patients Enrolled

Media Library

Computed Tomography Clinical Trial Eligibility Overview. Trial Name: NCT05779943 — Phase 2
Prostate Adenocarcinoma Research Study Groups: Treatment (furosemide, F-18 rhPSMA-7.3, PET-CT)
Prostate Adenocarcinoma Clinical Trial 2023: Computed Tomography Highlights & Side Effects. Trial Name: NCT05779943 — Phase 2
Computed Tomography 2023 Treatment Timeline for Medical Study. Trial Name: NCT05779943 — Phase 2
~12 spots leftby Jul 2027
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