NCT06862856

Flotufolastat F 18 PET in Men With Very Low PSA Recurrence

A Prospective Study of Flotufolastat F 18 Positron Emission Tomography in Men With Very Low Prostate Specific Antigen Recurrence

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 50 (estimated)
• Sponsor: Massachusetts General Hospital · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to assess detection rate of flotufolastat F 18 positron emission tomography (PET) for low prostate specific antigen (PSA) recurrence of prostate cancer (PC) following radical prostatectomy.

Detailed description

This is a prospective single arm study for the use of flotufolastat F 18 PET in men with very low prostate specific antigen recurrence. The research study involves collecting flotufolastat F 18 PET images to evaluate the detection rate. Flotufolastat F 18 is a radiopharmaceutical (radioactive agent) the U.S. Food and Drug Administration (FDA) has approved. Participation in this study will be for the duration of the flotufolastat F 18 PET scan. It is expected that about 50 people will take part in this research study.

Conditions

• Prostate Cancer (Adenocarcinoma)
• Prostate Specific Antigen

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Positron Emission Tomography (PET)	This is a PET scan with flotufolastat F 18 injection.

Timeline

• Start date: 2025-05-20
• Primary completion: 2026-04-01
• Completion: 2026-12-01
• First posted: 2025-03-06
• Last updated: 2025-11-13

Locations

2 sites across 1 country: United States