CancerPhase 2EDRN-FACBCNCT03081884
Validation of FACBC for Detection of Metastasis Among High-risk Prostate Cancer Patients With Presumed Localized Disease
A Phase 2 study testing FACBC PET-CT Imaging in people with Cancer, run by Emory University at 1 site in United States.
Trial summary
This study is for patients who have a high risk of metastatic prostate cancer (cancer that has spread outside of the prostate) who are going to have radical prostatectomy. The Anti-1-amino-3-[18F]fluorocyclobutyl-1-carboxylic acid (FACBC or Fluciclovine) positron emission tomography (PET) scan is a new imaging… Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Cancer
- What is being tested?
- FACBC PET-CT Imaging
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 61 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2017to 31 Dec 2019
- Phase
- Phase 2
- 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
- High-risk prostate cancer patients eligible for standard of care surgery
- At least clinical T3a disease, and/or Gleason≥8, and/or Prostate-Specific Antigen (PSA) >20, as per clinical assessment and routine guidelines
- Undergone standard of care conventional imaging (CT and/or MRI; bone scan and/or sodium fluoride (NaF) PET)
Who cannot join
- Definitive findings of systemic metastasis on conventional imaging.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Validation of FACBC as an Early Indicator of Sub-clinical Metastatic Disease Among High-risk Prostate Cancer Patients With Presumed Localized Disease
This study is for patients who have a high risk of metastatic prostate cancer (cancer that has spread outside of the prostate) who are going to have radical prostatectomy. The Anti-1-amino-3-[18F]fluorocyclobutyl-1-carboxylic acid (FACBC or Fluciclovine) positron emission tomography (PET) scan is a new imaging approach that has promising results in showing progression of cancer. The goal of this study is to determine if FACBC PET imaging will detect metastatic disease in patients with high risk prostate cancer who have negative conventional cross-sectional imaging such as computed tomography (CT) and/or magnetic resonance imaging (MRI), as well as bone scan and/or sodium fluoride PET. FACBC PET imaging may help detect metastatic prostate cancer in patients with newly diagnosed high risk primary prostate cancer and potentially improve staging of the cancer. Additionally, the researchers will compare the FACBC uptake in the prostate with uptake of FACBC detected in metastasis. They will also analyze and compare the prostate tissue, serum and urine parameters that are linked to higher rates of FACBC positivity.
Read the detailed description
Approximately 50-80% of patients who are considered high-risk after being treated with definitive radical prostatectomy experience recurrent disease, often because of undetected extra-prostatic metastatic disease prior to treatment. There is increasing evidence that performing radical prostatectomy in patients with high-risk disease or locally advanced disease is feasible and has potential benefits in terms of local control, overall survival, and quality of life. Thus, improved imaging approaches for early detection of occult metastatic prostate cancer at the time of presentation could inform a directed treatment approach that would significantly improve patient outcomes, including use of extended lymphadenectomy as well as postoperative radiation therapy planning.
Amino acid transport is up-regulated in prostate and other cancers. Anti-1-amino-3-[18F]fluorocyclobutyl-1-carboxylic acid (FACBC) is a synthetic amino acid analog positron emission tomography (PET) radiotracer that has demonstrated promising results in the staging and restaging of prostate carcinoma, with high positive predictive value (PPV) in the identification of extraprostatic malignancy. Most of the prior studies of FACBC were in post-primary treatment recurrence, and this proposed trial will be the first comprehensive study to evaluate FACBC PET in detecting occult metastatic disease at initial diagnosis in patients with negative or equivocal conventional imaging, with the objective of developing a more effective primary treatment plan.
The goal of this study is to determine if FACBC PET will detect significant occult metastatic disease in patients with high risk primary prostate carcinoma who have negative or equivocal conventional imaging such as CT and/or MRI and bone scan. Participants will have a single scan prior to surgery for this study. Participants will be followed, through medical record reviews, for 10 years but no additional procedures related to this study will be performed.
- Conditions
- Cancer
- Being tested
- FACBC PET-CT Imaging
- Keywords
- Prostate cancer, Metastatic cancer, Urogenital disorders, Oncology, Radiology
- Medical subject headings
- Neoplasms, Prostatic Neoplasms, Neoplasm Metastasis, Urogenital Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FACBC PET-CT ImagingDrug
Also called Fluciclovine
Participants will fast for 4 hours to normalize their neutral amino acid levels. One hour prior to the scan, participants will drink up to 450ml of standard oral contrast. Participants will lie on the scanning bed while the bed moves through the PET/CT scanner for the CT portion of the exam. After completion of the CT scan, approximately 10 units of FACBC will be injected for the PET scan portion of the exam. The bed will move through the scanner again and the PET portion of the exam will take 30 minutes. The entire visit will take about two hours.
Standard of care procedures include conventional imaging (CT and/or MRI; bone scan and/or NaF PET per institutional standards) and radical prostatectomy with extended pelvic lymph node dissection.
| Study group | Role | What they receive |
|---|---|---|
| FACBC PET-CT Imaging | Experimental | Individuals who have been diagnosed with primary prostate carcinoma and do not have definitive findings of systemic metastasis with conventional imaging will have a whole body FACBC PET-CT scan. Receives: Drug: FACBC PET-CT Imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cancer Detection Performance of FACBC PET/CT
The performance of FACBC PET/CT for diagnosing metastatic cancer was determined by confirming the FACBC PET/CT findings to the histological analysis of the lymph nodes.
Measured: Day 1
Secondary outcomes (1)
Diagnostic Performance of FACBC PET/CT and Conventional Imaging
The diagnostic performance of FACBC PET/CT in the detection of extraprostatic disease is compared to the diagnostic performance of standard imaging, as confirmed with lymph node histology.
Measured: Day 1, Day of surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2017
- Study start1 Mar 2017
- Primary completion31 Dec 2019
- Study completion31 Dec 2019
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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe 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 2
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- All participants will have the same intervention
- Masking
- None (open label)
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, David M Schuster, Emory University
- Investigators
- Mehrdad Alemozaffar, Principal investigator, Emory UniversityDavid M Schuster, MD, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03081884
- Sponsor's protocol ID
- IRB00092595
- Other IDs
- U01CA113913-11
- Acronym
- EDRN-FACBC
- Status last verified
- Jan 2021
- First submitted
- 28 Feb 2017
- Last updated
- 25 Jan 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Alemozaffar M, Akintayo AA, Abiodun-Ojo OA, Patil D, Saeed F, Huang Y, Osunkoya AO, Goodman MM, Sanda M, Schuster DM. [18F]Fluciclovine Positron Emission Tomography/Computerized Tomography for Preoperative Staging in Patients with Intermediate to High Risk Primary Prostate Cancer. J Urol. 2020 Oct;204(4):734-740. doi: 10.1097/JU.0000000000001095. Epub 2020 Apr 29.
PubMed 32347780
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of FACBC as an Early Indicator of Sub-clinical Metastatic Disease Among High-risk Prostate Cancer Patients With Presumed Localized Disease
- ClinicalTrials.gov ID
- NCT03081884
- Acronym / sponsor ID
- EDRN-FACBC / IRB00092595
- Conditions
- Cancer
- Keywords
- Prostate cancer, Metastatic cancer, Urogenital disorders, Oncology, Radiology
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 1 Mar 2017 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 16 Mar 2017 (actual)
- Results
- Posted 25 Jan 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is for patients who have a high risk of metastatic prostate cancer (cancer that has spread outside of the prostate) who are going to have radical prostatectomy. The Anti-1-amino-3-[18F]fluorocyclobutyl-1-carboxylic acid (FACBC or Fluciclovine) positron emission tomography (PET) scan is a new imaging approach that has promising results in showing progression of cancer. The goal of this study is to determine if FACBC PET imaging will detect metastatic disease in patients with high risk prostate cancer who have negative conventional cross-sectional imaging such as computed tomography (CT) and/or magnetic resonance imaging (MRI), as well as bone scan and/or sodium fluoride PET. FACBC PET imaging may help detect metastatic prostate cancer in patients with newly diagnosed high risk primary prostate cancer and potentially improve staging of the cancer. Additionally, the researchers will compare the FACBC uptake in the prostate with uptake of FACBC detected in metastasis. They will also analyze and compare the prostate tissue, serum and urine parameters that are linked to higher rates of FACBC positivity.
Detailed description
Approximately 50-80% of patients who are considered high-risk after being treated with definitive radical prostatectomy experience recurrent disease, often because of undetected extra-prostatic metastatic disease prior to treatment. There is increasing evidence that performing radical prostatectomy in patients with high-risk disease or locally advanced disease is feasible and has potential benefits in terms of local control, overall survival, and quality of life. Thus, improved imaging approaches for early detection of occult metastatic prostate cancer at the time of presentation could inform a directed treatment approach that would significantly improve patient outcomes, including use of extended lymphadenectomy as well as postoperative radiation therapy planning.
Amino acid transport is up-regulated in prostate and other cancers. Anti-1-amino-3-[18F]fluorocyclobutyl-1-carboxylic acid (FACBC) is a synthetic amino acid analog positron emission tomography (PET) radiotracer that has demonstrated promising results in the staging and restaging of prostate carcinoma, with high positive predictive value (PPV) in the identification of extraprostatic malignancy. Most of the prior studies of FACBC were in post-primary treatment recurrence, and this proposed trial will be the first comprehensive study to evaluate FACBC PET in detecting occult metastatic disease at initial diagnosis in patients with negative or equivocal conventional imaging, with the objective of developing a more effective primary treatment plan.
The goal of this study is to determine if FACBC PET will detect significant occult metastatic disease in patients with high risk primary prostate carcinoma who have negative or equivocal conventional imaging such as CT and/or MRI and bone scan. Participants will have a single scan prior to surgery for this study. Participants will be followed, through medical record reviews, for 10 years but no additional procedures related to this study will be performed.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All participants will have the same intervention
| Arm | Type | Receives |
|---|---|---|
| FACBC PET-CT Imaging | Experimental | Drug: FACBC PET-CT ImagingIndividuals who have been diagnosed with primary prostate carcinoma and do not have definitive findings of systemic metastasis with conventional imaging will have a whole body FACBC 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)
- High-risk prostate cancer patients eligible for standard of care surgery
- Undergone standard of care conventional imaging (CT and/or MRI; bone scan and/or sodium fluoride (NaF) PET)
Key exclusion criteria (1 listed)
- Definitive findings of systemic metastasis on conventional imaging.
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 |
|---|---|---|
| FACBC PET-CT ImagingAlso: FluciclovineParticipants will fast for 4 hours to normalize their neutral amino acid levels. One hour prior to the scan, participants will drink up to 450ml of standard oral contrast. Participants will lie on the scanning bed while the bed moves through the PET/CT scanner for the CT portion of the exam. After completion of the CT scan, approximately 10 units of FACBC will be injected for the PET scan portion of the exam. The bed will move through the scanner again and the PET portion of the exam will take 30 minutes. The entire visit will take about two hours. Standard of care procedures include conventional imaging (CT and/or MRI; bone scan and/or NaF PET per institutional standards) and radical prostatectomy with extended pelvic lymph node dissection. | Drug | FACBC PET-CT Imaging |
Primary outcome
Cancer Detection Performance of FACBC PET/CT
Time frame: Day 1
The performance of FACBC PET/CT for diagnosing metastatic cancer was determined by confirming the FACBC PET/CT findings to the histological analysis of the lymph nodes.
1 secondary outcome
Diagnostic Performance of FACBC PET/CT and Conventional Imaging
Time frame: Day 1, Day of surgery
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 32347780Alemozaffar M, Akintayo AA, Abiodun-Ojo OA, Patil D, Saeed F, Huang Y, Osunkoya AO, Goodman MM, Sanda M, Schuster DM. [18F]Fluciclovine Positron Emission Tomography/Computerized Tomography for Preoperative Staging in Patients with Intermediate to High Risk Primary Prostate Cancer. J Urol. 2020 Oct;204(4):734-740. doi: 10.1097/JU.0000000000001095. Epub 2020 Apr 29.
- 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. This study is not recruiting at the moment.
Mehrdad Alemozaffar principal investigator
Emory University
David M Schuster, MD principal investigator
Emory University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing FACBC PET-CT Imaging in people with Cancer, run by Emory University 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 3 inclusion and 1 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 25 Jan 2021. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 25 Jan 2021). 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?
Cancer Detection Performance of FACBC PET/CT (time frame: Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03081884, which also lists 1 linked publication.
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 25 Jan 2021.