NCT07569926 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
| NCT ID | NCT07569926 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Blue Earth Diagnostics |
| Condition | Prostate Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 142 participants |
| Start Date | 2026-08-31 |
| Primary Completion | 2027-12-31 |
Eligibility & Interventions
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 142 participants in total. It began in 2026-08-31 with a primary completion date of 2027-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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
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.
Contact & Investigator
Nadine Mallak, MD
PRINCIPAL INVESTIGATOR
Oregon Health and Science University
Frequently Asked Questions
Who can join the NCT07569926 clinical trial?
This trial is open to male participants only, aged 18 Years or older, studying Prostate Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07569926 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT07569926 currently recruiting?
Yes, NCT07569926 is actively recruiting participants. Contact the research team at bed-flc-401_study@bracco.com for enrollment information.
Where is the NCT07569926 trial being conducted?
This trial is being conducted at San Diego, United States, Atlanta, United States, Boston, United States, St Louis, United States and 2 additional locations.
Who is sponsoring the NCT07569926 clinical trial?
NCT07569926 is sponsored by Blue Earth Diagnostics. The principal investigator is Nadine Mallak, MD at Oregon Health and Science University. The trial plans to enroll 142 participants.
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