Recurrent Prostate CancerNCT01967862
Fluorine F 18 Sodium Fluoride PET/CT and Whole Body and Axial MRI in Finding Metastases in Patients With Recurrent Prostate Cancer
A study testing computed tomography, bone scan and 3-Tesla magnetic resonance imaging in people with Recurrent Prostate Cancer, run by City of Hope Medical Center at 2 sites in United States.
Trial summary
This phase II trial studies how well fluorine F 18 sodium fluoride positron emission tomography (PET)/computed tomography (CT) and whole body and axial magnetic resonance imaging (MRI) work in finding metastases in patients with recurrent prostate cancer. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Recurrent Prostate Cancer
- What is being tested?
- computed tomography, bone scan and 3-Tesla magnetic resonance imaging
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 2 sitesUnited States
- Study dates
- 17 Mar 2014to 17 Sep 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- History of prior radical prostatectomy for prostate cancer
- Two PSA values >= 0.2 ng/mL at least 4 weeks after prostatectomy
- Patients who have started radiographic evaluation and underwent CT scan and/or bone scan prior to registration to the study will be able to participate under a late registration provision, provided that the more modern scans (WB/axial MRI and F-18 NaF PET/CT) can be completed within 8 weeks after CT scan and bone scan
Who cannot join
- Patients with known metastatic disease
- PSA recurrence not verified by elevated PSA as discussed in the eligibility section
- Patients who initiated androgen deprivation therapy or other systemic therapy (chemotherapy, immunotherapy, targeted therapy) for PSA recurrence; nutritional supplements used for treatment of PSA recurrence will be allowed
Trial locations and contacts
2 sites in 1 country.
United States2 sites
City of Hope Medical Center
Duarte, California, 91010
City of Hope South Pasadena
South Pasadena, California, 91030
About this study
Official title: F18 NaF PET/CT and Whole Body and Axial MRI for the Detection of Metastases in Patients With Biochemical Recurrence of Prostate Cancer
This phase II trial studies how well fluorine F 18 sodium fluoride positron emission tomography (PET)/computed tomography (CT) and whole body and axial magnetic resonance imaging (MRI) work in finding metastases in patients with recurrent prostate cancer. New imaging techniques, such as fluorine F 18 sodium fluoride PET/CT and whole body and axial MRI, may be more effective than standard CT and bone scan in finding metastatic prostate cancer.
Read the detailed description
PRIMARY OBJECTIVES:
- To determine the proportion of patients with biochemically-recurrent prostate cancer (PC) in whom imaging with whole body (WB)/axial MRI and F-18 NaF (fluorine F 18 sodium fluoride) PET/CT results in detection of metastatic disease not visualized on CT scan and bone scan.
SECONDARY OBJECTIVES:
- To estimate the percent of eligible patients with negative, indeterminate and positive CT scan/bone scan and targeted X-rays if done.
II. To determine the proportion of patients with biochemically-recurrent PC in whom recurrence in the prostate bed can be visualized using MRI in the absence of detection using CT scan.
III. To correlate the presence of metastatic disease detected using WB/axial MRI and/or F-18 NaF PET/CT with the predicted 6-year probability of progression-free survival based on the Memorial Sloan Kettering Cancer Center salvage radiation therapy (RT) PC nomogram, and with prostate-specific antigen (PSA) level at baseline.
IV. To compare the role of axial MRI of the spine to WB/axial MRI with respect to their ability to identify sites of disease. Similarly, to evaluate the relative contribution of F-18 NaF PET and WB/axial MRI.
OUTLINE:
Patients first undergo CT scan and bone scan. Patients with negative results from the CT and bone scans then undergo WB MRI scan using diffusion-weighted MRI, axial MRI scan using 3-Tesla MRI, and fluorine F 18 sodium fluoride PET/CT scan.
After completion of study, patients are followed up at 4-6 months and periodically until week 52.
- Conditions
- Recurrent Prostate Cancer
- Being tested
- computed tomography, bone scan, 3-Tesla magnetic resonance imaging, diffusion-weighted magnetic resonance imaging, fluorine F 18 sodium fluoride
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
computed tomographyProcedure or surgery
Also called tomography, computed
Undergo CT
bone scanProcedure or surgery
Undergo bone scan
3-Tesla magnetic resonance imagingProcedure or surgery
Also called 3-Tesla MRI, 3T MRI
Undergo axial MRI
diffusion-weighted magnetic resonance imagingProcedure or surgery
Also called diffusion-weighted MRI
Undergo WB MRI
fluorine F 18 sodium fluorideRadiation
Also called 18 F-NaF, F-18 NaF
Undergo fluorine F 18 sodium fluoride PET/CT
computed tomographyProcedure or surgery
Also called tomography, computed
Undergo fluorine F 18 sodium fluoride PET/CT
positron emission tomographyProcedure or surgery
Also called FDG-PET, PET, PET scan, tomography, emission computed
Undergo fluorine F 18 sodium fluoride PET/CT
laboratory biomarker analysisOther
Correlative studies
| Study group | Role | What they receive |
|---|---|---|
| Diagnostic (CT, bone scan, WB/axial MRI, F18 NaF PET/CT) | Experimental | Patients first undergo CT scan and bone scan. Patients with negative results from the CT and bone scans then undergo WB MRI scan using diffusion-weighted MRI, axial MRI scan using 3-Tesla MRI, and fluorine F 18 sodium fluoride PET/CT scan. Receives: Procedure: computed tomography; Procedure: bone scan; Procedure: 3-Tesla magnetic resonance imaging; Procedure: diffusion-weighted magnetic resonance imaging; Radiation: fluorine F 18 sodium fluoride; Procedure: positron emission tomography; Other: laboratory biomarker analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Eligible Patients With Positive CT Scan/Bone Scan, MRI and PET Scan.
Count of eligible patients with positive CT chest, abdomen, pelvis scan, positive WB/axial MRI, positive F-18 NaF PET/CT and positive Bone scan for detection of metastatic disease.
Measured: Up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2013 (estimated)
- Study start17 Mar 2014
- Primary completion17 Sep 2018
- Study completion17 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Recurrent Prostate CancerStudies of the same condition, open and under way.
- More trials run by City of Hope Medical CenterThe 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 N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- City of Hope Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Cy Stein, MD, PhD, Principal investigator, City of Hope Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01967862
- Sponsor's protocol ID
- 13365
- Other IDs
- NCI-2013-01924, 13365
- Status last verified
- Oct 2026
- First submitted
- 18 Oct 2013
- Last updated
- 3 Nov 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- F18 NaF PET/CT and Whole Body and Axial MRI for the Detection of Metastases in Patients With Biochemical Recurrence of Prostate Cancer
- ClinicalTrials.gov ID
- NCT01967862
- Acronym / sponsor ID
- 13365
- Conditions
- Recurrent Prostate Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- City of Hope Medical CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 17 Mar 2014 (actual)
- Primary completion
- 17 Sep 2018 (actual)
- Study completion
- 17 Sep 2018 (actual)
- First posted
- 23 Oct 2013 (estimated)
- Results
- Posted 17 Sep 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This phase II trial studies how well fluorine F 18 sodium fluoride positron emission tomography (PET)/computed tomography (CT) and whole body and axial magnetic resonance imaging (MRI) work in finding metastases in patients with recurrent prostate cancer. New imaging techniques, such as fluorine F 18 sodium fluoride PET/CT and whole body and axial MRI, may be more effective than standard CT and bone scan in finding metastatic prostate cancer.
Detailed description
PRIMARY OBJECTIVES:
- To determine the proportion of patients with biochemically-recurrent prostate cancer (PC) in whom imaging with whole body (WB)/axial MRI and F-18 NaF (fluorine F 18 sodium fluoride) PET/CT results in detection of metastatic disease not visualized on CT scan and bone scan.
SECONDARY OBJECTIVES:
- To estimate the percent of eligible patients with negative, indeterminate and positive CT scan/bone scan and targeted X-rays if done.
II. To determine the proportion of patients with biochemically-recurrent PC in whom recurrence in the prostate bed can be visualized using MRI in the absence of detection using CT scan.
III. To correlate the presence of metastatic disease detected using WB/axial MRI and/or F-18 NaF PET/CT with the predicted 6-year probability of progression-free survival based on the Memorial Sloan Kettering Cancer Center salvage radiation therapy (RT) PC nomogram, and with prostate-specific antigen (PSA) level at baseline.
IV. To compare the role of axial MRI of the spine to WB/axial MRI with respect to their ability to identify sites of disease. Similarly, to evaluate the relative contribution of F-18 NaF PET and WB/axial MRI.
OUTLINE:
Patients first undergo CT scan and bone scan. Patients with negative results from the CT and bone scans then undergo WB MRI scan using diffusion-weighted MRI, axial MRI scan using 3-Tesla MRI, and fluorine F 18 sodium fluoride PET/CT scan.
After completion of study, patients are followed up at 4-6 months and periodically until week 52.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Diagnostic (CT, bone scan, WB/axial MRI, F18 NaF PET/CT) | Experimental | Procedure: computed tomography, Procedure: bone scan, Procedure: 3-Tesla magnetic resonance imaging, Procedure: diffusion-weighted magnetic resonance imaging, Radiation: fluorine F 18 sodium fluoride, Procedure: positron emission tomography, Other: laboratory biomarker analysisPatients first undergo CT scan and bone scan. Patients with negative results from the CT and bone scans then undergo WB MRI scan using diffusion-weighted MRI, axial MRI scan using 3-Tesla MRI, and fluorine F 18 sodium fluoride PET/CT scan. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- History of prior radical prostatectomy for prostate cancer
- Two PSA values >= 0.2 ng/mL at least 4 weeks after prostatectomy
- Patients who have started radiographic evaluation and underwent CT scan and/or bone scan prior to registration to the study will be able to participate under a late registration provision, provided that the more modern scans (WB/axial MRI and F-18 NaF PET/CT) can be completed within 8 weeks after CT scan and bone scan
Key exclusion criteria (3 listed)
- Patients with known metastatic disease
- PSA recurrence not verified by elevated PSA as discussed in the eligibility section
- Patients who initiated androgen deprivation therapy or other systemic therapy (chemotherapy, immunotherapy, targeted therapy) for PSA recurrence; nutritional supplements used for treatment of PSA recurrence will be allowed
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 |
|---|---|---|
| computed tomographyAlso: tomography, computedUndergo CT | Procedure or surgery | Diagnostic (CT, bone scan, WB/axial MRI, F18 NaF PET/CT) |
| bone scanUndergo bone scan | Procedure or surgery | Diagnostic (CT, bone scan, WB/axial MRI, F18 NaF PET/CT) |
| 3-Tesla magnetic resonance imagingAlso: 3-Tesla MRI, 3T MRIUndergo axial MRI | Procedure or surgery | Diagnostic (CT, bone scan, WB/axial MRI, F18 NaF PET/CT) |
| diffusion-weighted magnetic resonance imagingAlso: diffusion-weighted MRIUndergo WB MRI | Procedure or surgery | Diagnostic (CT, bone scan, WB/axial MRI, F18 NaF PET/CT) |
| fluorine F 18 sodium fluorideAlso: 18 F-NaF, F-18 NaFUndergo fluorine F 18 sodium fluoride PET/CT | Radiation | Diagnostic (CT, bone scan, WB/axial MRI, F18 NaF PET/CT) |
| computed tomographyAlso: tomography, computedUndergo fluorine F 18 sodium fluoride PET/CT | Procedure or surgery | Diagnostic (CT, bone scan, WB/axial MRI, F18 NaF PET/CT) |
| positron emission tomographyAlso: FDG-PET, PET, PET scan, tomography, emission computedUndergo fluorine F 18 sodium fluoride PET/CT | Procedure or surgery | Diagnostic (CT, bone scan, WB/axial MRI, F18 NaF PET/CT) |
| laboratory biomarker analysisCorrelative studies | Other | Diagnostic (CT, bone scan, WB/axial MRI, F18 NaF PET/CT) |
Primary outcome
Number of Eligible Patients With Positive CT Scan/Bone Scan, MRI and PET Scan.
Time frame: Up to 12 months
Count of eligible patients with positive CT chest, abdomen, pelvis scan, positive WB/axial MRI, positive F-18 NaF PET/CT and positive Bone scan for detection of metastatic disease.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Cy Stein, MD, PhD principal investigator
City of Hope Medical Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing computed tomography, bone scan and 3-Tesla magnetic resonance imaging in people with Recurrent Prostate Cancer, run by City of Hope Medical Center at 2 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 3 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: finished, as of the sponsor's last update on 3 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 2 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 17 Sep 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 Eligible Patients With Positive CT Scan/Bone Scan, MRI and PET Scan. (time frame: Up to 12 months). 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 3 Nov 2026.