Impact of fluciclovine PET on guiding care for men with biochemical recurrence after negative or unclear PSMA PET

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a prospective, multi-institutional Phase 4 trial evaluating how often management changes occur after adding fluciclovine (18F) PET imaging in men with prostate cancer and biochemical recurrence who previously had a negative or equivocal PSMA PET. Participants have rising or detectable PSA after definitive therapy and meet specific PSMA PET criteria. The study aims to determine the impact of the imaging results on subsequent treatment decisions. It is sponsored by Blue Earth Diagnostics and conducted at three major centers in the United States. Primary outcomes focus on changes in clinical management following the new imaging information.

Why it matters

Who can join: the full rules

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.

Where it's running

• Emory University
  Atlanta, Georgia, United States Recruiting
• Massachusetts General Hospital
  Boston, Massachusetts, United States Recruiting
• Oregon Health & Science University
  Portland, Oregon, United States Recruiting
• Urology Austin
  Austin, Texas, United States Recruiting
• University of California San Diego Health
  San Diego, California, United States Not yet recruiting
• Washington University
  St Louis, Missouri, United States Not yet recruiting

Study contacts

• Principal investigator: Nadine Mallak, MD — Oregon Health and Science University
• Study coordinator: BED-Flc-401 Study Team
• Email: bed-flc-401_study@bracco.com
• Phone: +44 (0) 1865 507300

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.