NCT05722925

Brief Summary

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for phase_4 prostate-cancer

Timeline
6mo left

Started Oct 2023

Typical duration for phase_4 prostate-cancer

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress82%
Oct 2023Dec 2026

First Submitted

Initial submission to the registry

February 1, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

February 10, 2023

Completed
8 months until next milestone

Study Start

First participant enrolled

October 4, 2023

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Last Updated

November 14, 2025

Status Verified

November 1, 2025

Enrollment Period

3.2 years

First QC Date

February 1, 2023

Last Update Submit

November 13, 2025

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (1)

  • Number of participants with BCR and a positive Fluciclovine PET performed within 30 days after a negative or equivocal PSMA PET

    During PET scan procedure

Secondary Outcomes (3)

  • Correct localization rate (CLR) of Fluciclovine PET in patients with positive scans.

    During PET scan procedure

  • Number of participants with positive Fluciclovine PET summarized by site of recurrence (local recurrence in the prostate bed, lymph node involvement, or distant metastatic disease), stratified by PSA level

    During PET scan procedure

  • Change in management based on the results of Fluciclovine PET, relative to intended management based on the result of negative PSMA PET alone, prior to obtaining the Fluciclovine PET.

    Enrollment up to 1 month after scan

Study Arms (1)

Fluciclovine PET/CT

EXPERIMENTAL

Participants will undergo Fluciclovine PET/CT within 30 days of a negative or equivocal PSMA PET scan. After the Fluciclovine PET/CT, the patient will follow up with their treating physician as per standard-of-care. The research team will collect clinical and imaging data at 6 months post Fluciclovine-PET/CT.

Drug: Fluciclovine PET/CT

Interventions

Fluciclovine PET/CTDRUG

8 mCi (± 20%) of Fluciclovine administered as a bolus intravenous injection

Also known as: 18F-FACBC, Axumin®
Fluciclovine PET/CT

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Oregon Health & Science University

Portland, Oregon, 97239, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

fluciclovine F-18

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Study Officials

  • Nadine Mallak, M.D.

    OHSU Knight Cancer Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 1, 2023

First Posted

February 10, 2023

Study Start

October 4, 2023

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2026

Last Updated

November 14, 2025

Record last verified: 2025-11

Locations

US(1)