Recruiting

Fluciclovine PET

Sponsor:

Blue Earth Diagnostics

Code:

NCT07569926

Conditions

Prostate Cancer

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

Interventions

fluciclovine (18F)

Study Details

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

Study ID

NCT07569926

Start date

Aug 31, 2026

Status verified date

Sep, 2026

Completion date

Dec 31, 2032

Anticipated

Primary completion date

Dec 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

142 participants

Anticipated

Intervention Model

Single group

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

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

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

Interventions

fluciclovine (18F)

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

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Locations

Oregon Health & Science University

Recruiting

Portland, Oregon, United States, 97239

More Information

Sponsor

Blue Earth Diagnostics

Last update posted

Sep 8, 2026

Last verified

Sep, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Blue Earth Diagnostics on 2026-09-08.