Prostate CancerPhase 4NCT05722925
Evaluating Fluciclovine PET in Patients With Biochemical Recurrence of Prostate Cancer and a Negative PSMA PET
A Phase 4 study testing Fluciclovine PET/CT in people with Prostate Cancer, run by OHSU Knight Cancer Institute at 1 site in United States.
Trial summary
The purpose of this prospective cohort study is to investigate the role of Fluciclovine Positron Emission Tomography (PET) in patients with biochemical recurrence of prostate cancer (BCR) and a negative Prostate Specific Membrane Antigen (PSMA) PET, specifically, whether Fluciclovine PET can help detect local… 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 PET/CT
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Oct 2023to 1 Dec 2026
- 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
- Age >= 18 years.
- Participant or legally authorized representative (LAR) must provide written informed consent before any study-specific procedures or interventions are performed.
- Patients with suspected BCR of prostate cancer after initial treatment, and a negative or equivocal PSMA PET, regardless of the findings on conventional imaging. Initial treatment may include prostatectomy and/or radiation therapy.
- PSA of 0.2 ng/mL or higher within 45 days of the scan.
Who cannot join
- Uncontrolled serious infection.
- Intercurrent illness or condition that would limit compliance with study requirements.
- Patients who have started any cancer treatment (systemic or radiation therapy) or who have started any supplements or herbal medications intended to treat cancer between the PSMA PET and Axumin PET/CT scans.
Trial locations and contacts
1 site in 1 country.
United States1 site
Oregon Health & Science University
Portland, Oregon, 97239
About this study
Official title: Prospective Study Evaluating the Role of Axumin® (Fluciclovine or 18F-FACBC) PET in Patients With Biochemical Recurrence of Prostate Cancer and a Negative PSMA PET
The purpose of this prospective cohort study is to investigate the role of Fluciclovine Positron Emission Tomography (PET) in patients with biochemical recurrence of prostate cancer (BCR) and a negative Prostate Specific Membrane Antigen (PSMA) PET, specifically, whether Fluciclovine PET can help detect local recurrence and whether the results of Fluciclovine PET can change management.
Read the detailed description
PRIMARY OBJECTIVE:
- To evaluate the detection rate of local recurrence of prostate cancer on Fluciclovine PET in patients with BCR and a negative or equivocal PSMA PET obtained within 30 days prior to the Fluciclovine PET.
SECONDARY OBJECTIVES:
- To evaluate the correct localization rate of Fluciclovine PET in patients with positive scans.
II. To distinguish the detection rate by site of recurrence (local recurrence in the prostate bed, lymph node involvement, or distant metastatic disease), and stratify by PSA level at the time of the scan and tumor grade
III. To evaluate the change in management based on the results of Fluciclovine PET, relative to intended management based on the result of negative PSMA PET alone, prior to obtaining the Fluciclovine PET.
OUTLINE:
Patients will be imaged with Fluciclovine PET within 30 days of the negative or equivocal PSMA scan.
A short questionnaire inquiring about the intended management will be sent to the referring physician at two timepoints: 1) the first is at the time of screening, prior to the Fluciclovine PET; and 2) the second is after the availability of the results of Fluciclovine PET.
Change in intended management will be recorded. Participants will be followed for 6 months and will be managed by their treating physician as per standard-of-care.
- Conditions
- Prostate Cancer
- Being tested
- Fluciclovine PET/CT
- 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 PET/CTDrug
Also called 18F-FACBC, Axumin®
8 mCi (± 20%) of Fluciclovine administered as a bolus intravenous injection
| Study group | Role | What they receive |
|---|---|---|
| Fluciclovine PET/CT | Experimental | Participants will undergo Fluciclovine PET/CT within 30 days of a negative or equivocal PSMA PET scan. After the Fluciclovine PET/CT, the patient will follow up with their treating physician as per standard-of-care. The research team will collect clinical and imaging data at 6 months post Fluciclovine-PET/CT. Receives: Drug: Fluciclovine PET/CT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with BCR and a positive Fluciclovine PET performed within 30 days after a negative or equivocal PSMA PET
Measured: During PET scan procedure
Secondary outcomes (3)
Correct localization rate (CLR) of Fluciclovine PET in patients with positive scans.
The CLR of Fluciclovine PET will be determined by the following formula: true positive/(true positive + false positive). This will be evaluated by patient, and only for patients in whom the standard-of-reference is available for analysis. Standard of reference, the combination of:
- Pathology, if site of recurrence is biopsied
- Drop in PSA levels if the site of recurrence undergoes radiation therapy
- Imaging follow up confirming the suspicious finding as true positive.
Measured: During PET scan procedure
Number of participants with positive Fluciclovine PET summarized by site of recurrence (local recurrence in the prostate bed, lymph node involvement, or distant metastatic disease), stratified by PSA level
Measured: During PET scan procedure
Change in management based on the results of Fluciclovine PET, relative to intended management based on the result of negative PSMA PET alone, prior to obtaining the Fluciclovine PET.
Questionnaire filled by the referring physician stating the intended management at 2 timepoints, before and after the Fluciclovine PET/CT.
Measured: Enrollment up to 1 month after scan
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2023
- Study start4 Oct 2023
- Primary completion1 Dec 2026 (estimated)
- Study completion1 Dec 2026 (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.
- More trials run by OHSU Knight Cancer InstituteThe sponsor's other registered studies.
- 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
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- OHSU Knight Cancer Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Blue Earth Diagnostics, Oregon Health and Science University
- Responsible party
- Principal investigator, Nadine Mallak, MD, OHSU Knight Cancer Institute
- Investigators
- Nadine Mallak, M.D., Principal investigator, OHSU Knight Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05722925
- Sponsor's protocol ID
- STUDY00024659
- Status last verified
- Jun 2026
- First submitted
- 1 Feb 2023
- Last updated
- 29 Jun 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Study Evaluating the Role of Axumin® (Fluciclovine or 18F-FACBC) PET in Patients With Biochemical Recurrence of Prostate Cancer and a Negative PSMA PET
- ClinicalTrials.gov ID
- NCT05722925
- Acronym / sponsor ID
- STUDY00024659
- Conditions
- Prostate Cancer
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- OHSU Knight Cancer InstituteUniversity, hospital or other
- Collaborators
- Blue Earth Diagnostics, Oregon Health and Science University
- Study start
- 4 Oct 2023 (actual)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 10 Feb 2023 (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 purpose of this prospective cohort study is to investigate the role of Fluciclovine Positron Emission Tomography (PET) in patients with biochemical recurrence of prostate cancer (BCR) and a negative Prostate Specific Membrane Antigen (PSMA) PET, specifically, whether Fluciclovine PET can help detect local recurrence and whether the results of Fluciclovine PET can change management.
Detailed description
PRIMARY OBJECTIVE:
- To evaluate the detection rate of local recurrence of prostate cancer on Fluciclovine PET in patients with BCR and a negative or equivocal PSMA PET obtained within 30 days prior to the Fluciclovine PET.
SECONDARY OBJECTIVES:
- To evaluate the correct localization rate of Fluciclovine PET in patients with positive scans.
II. To distinguish the detection rate by site of recurrence (local recurrence in the prostate bed, lymph node involvement, or distant metastatic disease), and stratify by PSA level at the time of the scan and tumor grade
III. To evaluate the change in management based on the results of Fluciclovine PET, relative to intended management based on the result of negative PSMA PET alone, prior to obtaining the Fluciclovine PET.
OUTLINE:
Patients will be imaged with Fluciclovine PET within 30 days of the negative or equivocal PSMA scan.
A short questionnaire inquiring about the intended management will be sent to the referring physician at two timepoints: 1) the first is at the time of screening, prior to the Fluciclovine PET; and 2) the second is after the availability of the results of Fluciclovine PET.
Change in intended management will be recorded. Participants will be followed for 6 months and will be managed by their treating physician as per standard-of-care.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Fluciclovine PET/CT | Experimental | Drug: Fluciclovine PET/CTParticipants will undergo Fluciclovine PET/CT within 30 days of a negative or equivocal PSMA PET scan. After the Fluciclovine PET/CT, the patient will follow up with their treating physician as per standard-of-care. The research team will collect clinical and imaging data at 6 months post Fluciclovine-PET/CT. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age >= 18 years.
- Participant or legally authorized representative (LAR) must provide written informed consent before any study-specific procedures or interventions are performed.
- Patients with suspected BCR of prostate cancer after initial treatment, and a negative or equivocal PSMA PET, regardless of the findings on conventional imaging. Initial treatment may include prostatectomy and/or radiation therapy.
- PSA of 0.2 ng/mL or higher within 45 days of the scan.
Key exclusion criteria (3 listed)
- Uncontrolled serious infection.
- Intercurrent illness or condition that would limit compliance with study requirements.
- Patients who have started any cancer treatment (systemic or radiation therapy) or who have started any supplements or herbal medications intended to treat cancer between the PSMA PET and Axumin PET/CT scans.
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 PET/CTAlso: 18F-FACBC, Axumin®8 mCi (± 20%) of Fluciclovine administered as a bolus intravenous injection | Drug | Fluciclovine PET/CT |
Primary outcome
Number of participants with BCR and a positive Fluciclovine PET performed within 30 days after a negative or equivocal PSMA PET
Time frame: During PET scan procedure
3 secondary outcomes
Correct localization rate (CLR) of Fluciclovine PET in patients with positive scans.
Time frame: During PET scan procedure
Number of participants with positive Fluciclovine PET summarized by site of recurrence (local recurrence in the prostate bed, lymph node involvement, or distant metastatic disease), stratified by PSA level
Time frame: During PET scan procedure
Change in management based on the results of Fluciclovine PET, relative to intended management based on the result of negative PSMA PET alone, prior to obtaining the Fluciclovine PET.
Time frame: Enrollment up to 1 month after scan
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 29 Jun 2026.
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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. This study is not recruiting at the moment.
Nadine Mallak, M.D. principal investigator
OHSU Knight Cancer Institute
1 site 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 PET/CT in people with Prostate Cancer, run by OHSU Knight Cancer Institute at 1 site 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 4 inclusion and 3 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: under way, not looking for participants, as of the sponsor's last update on 29 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with BCR and a positive Fluciclovine PET performed within 30 days after a negative or equivocal PSMA PET (time frame: During PET scan procedure). 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 29 Jun 2026.