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

NCT07569926 | Not Yet Recruiting Phase 4 FDA Drug

• 1 other identifier: BED-FLC-401
• Study Type: interventional
• Target: 142
• Locations: 1 country
• Sites: 4

Brief Summary

The impact of fluciclovine (18F) PET on the management of participants with prostate cancer following negative or equivocal PSMA PET Imaging at the time of biochemical recurrence

Conditions

Prostate Cancer

Keywords

Prostate Cancer; Biochemical Recurrence (BCR); Positron Emission Tomography (PET) Scan; Negative or equivocal PSMA PET scan

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (7)

• For those participants with a CIM, percentage of participants with a recorded minor or major CIM 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

• For those participants with a CIM, summary of the CIM groups 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

• Participant-level and region-level (prostate bed, pelvic lymph nodes [PLNs], other) detection rates.

  fluciclovine (18F) on Day 1, At least 24 hours after the piflufolastat (18F) scan, but within 30 calendar days

• Participant-level and region-level (prostate bed, PLNs, other) detection rates stratified by PSA levels.

  fluciclovine (18F) on Day 1, At least 24 hours after the piflufolastat (18F) scan, but within 30 calendar days

• Percentage of participants with any recorded CIM following a positive/negative fluciclovine (18F) PET/CT

  fluciclovine (18F) on Day 1, At least 24 hours after the piflufolastat (18F) scan, but within 30 calendar days

Study Arms (1)

Patients Single intravenous administration of fluciclovine (18F) for PET Scan

EXPERIMENTAL

Patients Single intravenous administration of fluciclovine (18F) for PET Scan

Drug: fluciclovine (18F)

Interventions

fluciclovine (18F) DRUG

fluciclovine (18F) injection, 370 MBq (10 mCi) ± 20%, delivered as an intravenous bolus.

Also known as: Axumin

Patients Single intravenous administration of fluciclovine (18F) for PET Scan

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants must be males aged ≥18 years at Screening.
• Participants suspicious for a biochemically recurrent prostate cancer with a detectable or rising PSA after definitive therapy on the basis of: Post-radical prostatectomy (with or without adjuvant or salvage radiation therapy): PSA that is ≥0.2 ng/mL (completed \>6 weeks after surgery) or Post-radiation therapy (with or without ADT): Increase in PSA level that is ≥2.0 ng/mL above the nadir PSA level and rising PSA is confirmed on consecutive PSA determinations.
• Men who are sexually active with women of childbearing potential (WOCBP), must agree to use a highly effective method(s) of contraception for 24 hours post-fluciclovine (18F) injection.
• Participants must provide written informed consent before any study-specific procedures or interventions are performed.
• Ability of the participants to comply with planned study procedures

You may not qualify if:

• Participants with known metastatic castrate resistant prostate cancer.
• Participants with any medical condition (including intercurrent illness and uncontrolled serious infection) or circumstance (including receiving an IP) that the investigator believes may compromise the data collected or lead to a failure to comply with the study requirements.
• Participants who are planned to have an x-ray contrast agent or any other PET radiotracer within five physical half-lives of the first PET radionuclide prior to the study fluciclovine (18F) PET/CT scan.
• Participants participating in an interventional clinical trial within 30 days and having received an IP five physical half-lives prior to the study fluciclovine (18F) PET/CT scan.
• Participants with known hypersensitivity to the active substance or to any of the excipients of fluciclovine (18F).
• Participants who have received salvage therapy for the current episode of BCR.
• Participants who initiate cancer treatment (systemic or radiation therapy) or who have started any supplements or herbal medications intended to treat cancer between the PSMA PET and fluciclovine (18F) PET/CT scans.

Sponsors & Collaborators

• Blue Earth Diagnostics: lead

Study Sites (4)

Emory University

Atlanta, Georgia, 30322, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Washington University

St Louis, Missouri, 63110, United States

Location

Oregon Health & Science University

Portland, Oregon, 97239, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

fluciclovine F-18

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Nadine Mallak, MD

  Oregon Health and Science University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lauren Dean

CONTACT

+44 (0) 1865 507300; lauren.dean@bracco.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 22, 2026
• First Posted: May 6, 2026
• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2032
• Last Updated: May 6, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)