Evaluating Fluciclovine PET in Patients With Biochemical Recurrence of Prostate Cancer and a Negative PSMA PET

Running, not enrolling · Phase 4

Conditions studied: Prostate Cancer

In brief

The purpose of this prospective cohort study is to investigate the role of Fluciclovine Positron Emission Tomography (PET) in patients with biochemical recurrence of prostate cancer (BCR) and a negative Prostate Specific Membrane Antigen (PSMA) PET, specifically, whether Fluciclovine PET can help detect local recurrence and whether the results of Fluciclovine PET can change management.

Key facts

Study ID

NCT05722925

Run by

OHSU Knight Cancer Institute

People needed

50

Starts

2023-10-04

Expected to finish

2026-12-01

Last updated by the study team

2026-06-29

Who can join

Age: 18 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• Age >= 18 years.
• Participant or legally authorized representative (LAR) must provide written informed consent before any study-specific procedures or interventions are performed.
• Patients with suspected BCR of prostate cancer after initial treatment, and a negative or equivocal PSMA PET, regardless of the findings on conventional imaging. Initial treatment may include prostatectomy and/or radiation therapy.
• PSA of 0.2 ng/mL or higher within 45 days of the scan.

You may not qualify if…

• Uncontrolled serious infection.
• Intercurrent illness or condition that would limit compliance with study requirements.
• Patients who have started any cancer treatment (systemic or radiation therapy) or who have started any supplements or herbal medications intended to treat cancer between the PSMA PET and Axumin PET/CT scans.

Where it is running

• Oregon Health & Science University — Portland, Oregon, United States

Full record on ClinicalTrials.gov

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