Fluciclovine (18F) PET for Prostate Cancer After Previous PSMA PET Scans

This study is looking at how a special type of scan, called fluciclovine (18F) PET, can help doctors manage prostate cancer. This is for men who have had their prostate cancer come back (biochemical recurrence) after treatment, and whose previous PSMA (Prostate-Specific Membrane Antigen) PET scans didn't clearly show where the cancer was. The study wants to see if the fluciclovine (18F) PET scan changes the treatment plan for these patients. To join, you must be a male aged 18 or older with prostate cancer recurrence and a recent negative or unclear PSMA PET scan. The main goal is to measure how many participants have a change in their treatment plan after getting the fluciclovine (18F) PET/CT scan, which will be measured within 30 days of the scan. The current status of this study is unclear, and it plans to enroll 142 participants.

Study design
This is a prospective, multi-institutional study that plans to enroll 142 participants. It is not specified if it is randomized or blinded.
What's involved
Participants will receive an intravenous injection of fluciclovine (18F) and undergo a PET/CT scan. This scan will occur at least 24 hours after a piflufolastat (18F) scan, but within 30 days.
Compensation
Not stated in the trial record.
Follow-up
The primary outcome, change in management, is measured within 30 calendar days after the fluciclovine (18F) scan.

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NCT07569926

Impact of Fluciclovine (18F) PET (Positron Emission Tomography) on the Management of Prostate Cancer Following Negative or Equivocal PSMA (Prostate-Specific Membrane Antigen) PET Imaging at the Time of Biochemical Recurrence

Not Yet Recruiting
PHASE4Ages 18+InterventionalDiagnostic
Blue Earth Diagnostics
~142 participants
Updated 2026-06-02 on ClinicalTrials.gov
What's tested:fluciclovine (18F)

At a glance

Recruiting sites
0 of 6 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Percentage of participants with any recorded Change In Management following a fluciclovine (18F) PET/CT scan.
Measured over fluciclovine (18F) on Day 1, At least 24 hours after the piflufolastat (18F) scan, but within 30 calendar days
Prostate Cancer
6 sites across 6 states
California1
Georgia1
Massachusetts1
Missouri1
Oregon1
Texas1
  • Nadine Mallak, MD · PRINCIPAL_INVESTIGATOR · Oregon Health and Science University

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  • Percentage of participants with any recorded Change In Management following a fluciclovine (18F) PET/CT scan.fluciclovine (18F) on Day 1, At least 24 hours after the piflufolastat (18F) scan, but within 30 calendar days