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

Official record

Identifier

NCT07569926

Recruiting locations

country

United States

Interventions studied

fluciclovine (18F)

Lead sponsor

Blue Earth Diagnostics

Target enrolment

142 participants

Study type

INTERVENTIONAL

Phase

Phase 4

Status

Recruiting

First posted

May 6, 2026

Last updated on the registry

Sep 29, 2026

Age

18 Years

Sex

MALE

Study contact

The official record lists a study contact. Contact details are published there and are intentionally not copied to this page.

Eligibility criteria

Reproduced verbatim from the official record. Eligibility is decided by the study team, never by this page.

Inclusion Criteria:

1. Participants must be males aged ≥18 years at Screening.
2. Participants with suspected BCR of prostate cancer (see Inclusion Criterion #3 below) following prior curative intent treatment and a negative or equivocal PSMA PET scan with any FDA-approved PSMA PET tracer (must be within 45 days prior to Visit 2 \[fluciclovine (18F) PET/CT scan\]), regardless of findings on conventional imaging.
3. 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.
4. 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.
5. Participants must provide written informed consent before any study-specific procedures or interventions are performed.
6. Ability of the participants to comply with planned study procedures

Exclusion Criteria:

1. Participants with known metastatic castrate resistant prostate cancer.
2. 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.
3. 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.
4. 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.
5. Participants with known hypersensitivity to the active substance or to any of the excipients of fluciclovine (18F).
6. Participants who have received salvage therapy for the current episode of BCR.
7. 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.

Indexed under

Prostate Cancer