Prostate CancerPhase 4NCT07569926
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
A Phase 4 study testing fluciclovine (18F) in people with Prostate Cancer, run by Blue Earth Diagnostics at 6 sites in United States.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- fluciclovine (18F)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 142 participants
- Where
- 6 sitesUnited States
- Study dates
- 31 Aug 2026to 31 Dec 2032
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants must be males aged ≥18 years at Screening.
- 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.
- 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.
- 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.
- Participants must provide written informed consent before any study-specific procedures or interventions are performed.
- Ability of the participants to comply with planned study procedures
Who cannot join
- Participants with known metastatic castrate resistant prostate cancer.
- 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.
- 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.
- 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.
- Participants with known hypersensitivity to the active substance or to any of the excipients of fluciclovine (18F).
- Participants who have received salvage therapy for the current episode of BCR.
- 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.
Trial locations and contacts
6 sites in 1 country. Contact the study team or a site near you to ask about taking part.
6 sites in 1 country
United States6 sites, 6 recruiting
- Recruiting
Emory University
Atlanta, Georgia, 30322
Ismaheel Lawal, MD
- Recruiting
Urology Austin
Austin, Texas, 78759
Brian Mazzarella, MD
- Recruiting
Massachusetts General Hospital
Boston, Massachusetts, 02114
Pedram Heidari, MD
- Recruiting
Oregon Health & Science University
Portland, Oregon, 97239
Nadine Mallak, MD
- Not yet recruiting
University of California San Diego Health
San Diego, California, 92103
Sherief H Gamie, MD
- Not yet recruiting
Washington University
St Louis, Missouri, 63110
Ashwin Parihar, MD
About this study
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
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
Read the detailed description
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)
- Conditions
- Prostate Cancer
- Being tested
- fluciclovine (18F)
- Keywords
- Prostate Cancer, Biochemical Recurrence (BCR), Positron Emission Tomography (PET) Scan, Negative or equivocal PSMA PET scan
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fluciclovine (18F)Drug
Also called Axumin
fluciclovine (18F) injection, 370 MBq (10 mCi) ± 20%, delivered as an intravenous bolus.
| Study group | Role | What they receive |
|---|---|---|
| Patients Single intravenous administration of fluciclovine (18F) for PET Scan | Experimental | Patients Single intravenous administration of fluciclovine (18F) for PET Scan Receives: Drug: fluciclovine (18F) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of participants with any recorded Change In Management following a fluciclovine (18F) PET/CT scan.
Measured: fluciclovine (18F) on Day 1, At least 24 hours after the piflufolastat (18F) scan, but within 30 calendar days
Secondary outcomes (7)
For those participants with a change in management (CIM), percentage of participants with a recorded minor or major CIM following a fluciclovine (18F) PET/CT scan.
Measured: fluciclovine (18F) on Day 1, At least 24 hours after the piflufolastat (18F) scan, but within 30 calendar days
For those participants with a CIM, summary of the CIM groups following a fluciclovine (18F) PET/CT scan.
Measured: fluciclovine (18F) on Day 1, At least 24 hours after the piflufolastat (18F) scan, but within 30 calendar days
Participant-level and region-level (prostate bed, pelvic lymph nodes [PLNs], other) detection rates.
Measured: fluciclovine (18F) on Day 1, At least 24 hours after the piflufolastat (18F) scan, but within 30 calendar days
Participant-level and region-level (prostate bed, PLNs, other) detection rates stratified by PSA levels.
Measured: fluciclovine (18F) on Day 1, At least 24 hours after the piflufolastat (18F) scan, but within 30 calendar days
Percentage of participants with any recorded CIM following a positive/negative fluciclovine (18F) PET/CT
Measured: fluciclovine (18F) on Day 1, At least 24 hours after the piflufolastat (18F) scan, but within 30 calendar days
Percentage of participants with a recorded minor or major CIM following a positive/negative fluciclovine (18F) PET/CT
Measured: fluciclovine (18F) on Day 1, At least 24 hours after the piflufolastat (18F) scan, but within 30 calendar days
For those participants with a CIM, summary of CIM groups following a positive/negative fluciclovine (18F) PET/CT
Measured: fluciclovine (18F) on Day 1, At least 24 hours after the piflufolastat (18F) scan, but within 30 calendar days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2026
- Study start31 Aug 2026
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 142 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Blue Earth Diagnostics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Nadine Mallak, MD, Principal investigator, Oregon Health and Science University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07569926
- Sponsor's protocol ID
- BED-FLC-401
- Status last verified
- Nov 2026
- First submitted
- 22 Apr 2026
- Last updated
- 5 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07569926
- Acronym / sponsor ID
- BED-FLC-401
- Conditions
- Prostate Cancer
- Keywords
- Prostate Cancer, Biochemical Recurrence (BCR), Positron Emission Tomography (PET) Scan, Negative or equivocal PSMA PET scan
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 142 participants (estimated)
- Lead sponsor
- Blue Earth DiagnosticsIndustry (pharma, biotech, devices)
- Study start
- 31 Aug 2026 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2032 (estimated)
- First posted
- 6 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
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)
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients Single intravenous administration of fluciclovine (18F) for PET Scan | Experimental | Drug: fluciclovine (18F)Patients Single intravenous administration of fluciclovine (18F) for PET Scan |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Participants must be males aged ≥18 years at Screening.
- 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.
- 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.
- 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.
- Participants must provide written informed consent before any study-specific procedures or interventions are performed.
Key exclusion criteria (7 listed)
- Participants with known metastatic castrate resistant prostate cancer.
- 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.
- 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.
- 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.
- Participants with known hypersensitivity to the active substance or to any of the excipients of fluciclovine (18F).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| fluciclovine (18F)Also: Axuminfluciclovine (18F) injection, 370 MBq (10 mCi) ± 20%, delivered as an intravenous bolus. | Drug | Patients Single intravenous administration of fluciclovine (18F) for PET Scan |
Primary outcome
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
7 secondary outcomes
For those participants with a change in management (CIM), percentage of participants with a recorded minor or major CIM 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
For those participants with a CIM, summary of the CIM groups 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
Participant-level and region-level (prostate bed, pelvic lymph nodes [PLNs], other) detection rates.
Time frame: fluciclovine (18F) on Day 1, At least 24 hours after the piflufolastat (18F) scan, but within 30 calendar days
Participant-level and region-level (prostate bed, PLNs, other) detection rates stratified by PSA levels.
Time frame: fluciclovine (18F) on Day 1, At least 24 hours after the piflufolastat (18F) scan, but within 30 calendar days
Percentage of participants with any recorded CIM following a positive/negative fluciclovine (18F) PET/CT
Time frame: fluciclovine (18F) on Day 1, At least 24 hours after the piflufolastat (18F) scan, but within 30 calendar days
Percentage of participants with a recorded minor or major CIM following a positive/negative fluciclovine (18F) PET/CT
Time frame: fluciclovine (18F) on Day 1, At least 24 hours after the piflufolastat (18F) scan, but within 30 calendar days
For those participants with a CIM, summary of CIM groups following a positive/negative fluciclovine (18F) PET/CT
Time frame: fluciclovine (18F) on Day 1, At least 24 hours after the piflufolastat (18F) scan, but within 30 calendar days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Nadine Mallak, MD principal investigator
Oregon Health and Science University
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing fluciclovine (18F) in people with Prostate Cancer, run by Blue Earth Diagnostics at 6 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact BED-Flc-401 Study Team (+44 (0) 1865 507300, bed-flc-401_study@bracco.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2026; AzTrials last refreshed its copy on 8 Nov 2026.