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18F-RhPSMA 7.3 PET/CT With and Without Furosemide in Biochemical Recurrence of Prostate Cancer
NCT05779943Phase 2
Key facts
- Status
- Active, not recruiting
- Start
- Apr 2023
- Primary completion
- Mar 2024
- Countries
- 1
- Sponsor
- Emory University
- Modality
- Small Molecules
- Drugs
- furosemide
- Conditions
- prostate cancer (PCa)
01
Overview
Phase 2, open-label, single-arm trial of furosemide in prostate cancer (PCa), sponsored by Emory University. Primary endpoint: Change in Bladder Activity as Measured by Bladder Standardized Uptake Value (SUV) Mean at 2 weeks. Started Apr 2023; status: active, not recruiting.
02
Design
1 arm- Study design
- Non-randomizedOpen-labelSingle group
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.
03
Who it enrols
Adult males with biochemically recurrent prostate adenocarcinoma post-prostatectomy (PSA >= 0.2 ng/mL) and normal creatinine levels.
04
Endpoints
Primary
Change in Bladder Activity as Measured by Bladder Standardized Uptake Value (SUV) Mean
Secondary
Change in Bladder and Renal Activity (Kidney SUV)
Change in Bladder and Renal Activity (Bladder Volume)
Recurrent Disease Rate
Reader Confidence Score
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