RecruitingRecruiting
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 · Blue Earth Diagnostics
In plain English
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Official title
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
About this study
This is a prospective, multi-institutional, Phase 4 study to assess change in management (CIM) following fluciclovine (18F) imaging in participants with prostate cancer who have a negative or equivocal prostate-specific membrane antigen (PSMA) positron emission tomography (PET) scan at the time of any biochemical recurrence (BCR)
Eligibility criteria
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 target: 142 participants
Allocation: na
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2026-08-31
Estimated completion: 2032-12-31
Last updated: 2026-09-08
Interventions
Drug: fluciclovine (18F)
Primary outcomes
- • 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)
Sponsor
Blue Earth Diagnostics · industry
Contacts & investigators
ContactBED-Flc-401 Study Team · contact · bed-flc-401_study@bracco.com · +44 (0) 1865 507300
InvestigatorNadine Mallak, MD · principal_investigator, Oregon Health and Science University
All locations (6)
University of California San Diego HealthNot Yet Recruiting
San Diego, California, United States
Emory UniversityNot Yet Recruiting
Atlanta, Georgia, United States
Massachusetts General HospitalNot Yet Recruiting
Boston, Massachusetts, United States
Washington UniversityNot Yet Recruiting
St Louis, Missouri, United States
Oregon Health & Science UniversityRecruiting
Portland, Oregon, United States
Urology AustinNot Yet Recruiting
Austin, Texas, United States