NCT06604442

Intrapatient Comparison of Urinary Radioactivity Following Piflufolastat (18F) and Flotufolastat (18F) PET in Men With Low PSA Biochemical Recurrence of Prostate Cancer Following Radical Prostatectomy

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 55 (actual)
• Sponsor: Blue Earth Diagnostics · Industry
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Intrapatient Comparison of Urinary Radioactivity Following Piflufolastat (18F) and Flotufolastat (18F) PET in Men with Low PSA Biochemical Recurrence of Prostate Cancer Following Radical Prostatectomy

Detailed description

This is a multi-center, prospective intra-patient comparator study of urinary radioactivity (standardized uptake values \[SUV\]) following both piflufolastat (18F) and flotufolastat (18F) positron emission tomography (PET) in patients with low prostate-specific antigen (PSA; ≤0.5 ng/mL) biochemical recurrence (BCR) of prostate cancer following radical prostatectomy (RP).

Conditions

• Prostate Cancer

Interventions

Type	Name	Description
DRUG	Flotufolastat (18F)	Positron emission tomography (PET)
DRUG	piflufolastat (18F)	Positron emission tomography (PET)

Timeline

• Start date: 2024-12-04
• Primary completion: 2025-08-29
• Completion: 2025-08-29
• First posted: 2024-09-19
• Last updated: 2025-09-11

Locations

9 sites across 1 country: United States

Regulatory

• FDA-regulated drug study