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Validation of FACBC for Detection of Metastasis Among High-risk Prostate Cancer Patients With Presumed Localized Disease (EDRN-FACBC)

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2017 by Emory University
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Mehrdad Alemozaffar, Emory University
ClinicalTrials.gov Identifier:
NCT03081884
First received: February 28, 2017
Last updated: March 10, 2017
Last verified: March 2017
  Purpose
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.

Condition Intervention Phase
Cancer
Drug: FACBC PET-CT Imaging
Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Intervention Model Description:
All participants will have the same intervention
Masking: No masking
Primary Purpose: Diagnostic
Official Title: Validation of FACBC as an Early Indicator of Sub-clinical Metastatic Disease Among High-risk Prostate Cancer Patients With Presumed Localized Disease

Resource links provided by NLM:


Further study details as provided by Emory University:

Primary Outcome Measures:
  • Positivity rate of FACBC PET [ Time Frame: Day 1 ]
    To validate FACBC as an early indicator of occult metastatic disease among high risk prostate cancer patients with presumed localized disease, the positivity rate will be calculated for FACBC PET for extraprostatic disease.

  • Correlation between FACBC PET findings and results of other tests [ Time Frame: Day 1, Day of surgery ]
    To validate FACBC as an early indicator of occult metastatic disease among high risk prostate cancer patients with presumed localized disease, the diagnostic performance of FACBC in the detection of extraprostatic disease as confirmed with histology and/or correlative imaging will be determined.


Secondary Outcome Measures:
  • Correlation between FACBC uptake in the prostate with presence of FACBC-detected metastasis [ Time Frame: Day 1 ]
    Using results from the FACBC PET scan, the uptake of known tumor within the prostate will be correlated with the uptake of FACBC outside of the main tumor.


Estimated Enrollment: 88
Actual Study Start Date: March 1, 2017
Estimated Study Completion Date: January 2027
Estimated Primary Completion Date: January 2027 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: FACBC PET-CT Imaging
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.
Drug: FACBC PET-CT Imaging

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.

Other Name: Fluciclovine

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.

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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)

Exclusion Criteria:

  • Definitive findings of systemic metastasis on conventional imaging.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT03081884

Contacts
Contact: Mehrdad Alemozaffar 404-778-5864
Contact: Almira Catic 404-778-7397

Locations
United States, Georgia
Emory University Hospital Recruiting
Atlanta, Georgia, United States, 30322
Contact: Mehrdad Alemozaffar, MD    404-778-5864    malemoz@emory.edu   
Sponsors and Collaborators
Emory University
National Cancer Institute (NCI)
Investigators
Principal Investigator: Mehrdad Alemozaffar Emory University
  More Information

Responsible Party: Mehrdad Alemozaffar, Assistant Professor, Emory University
ClinicalTrials.gov Identifier: NCT03081884     History of Changes
Other Study ID Numbers: IRB00092595
U01CA113913-11 ( US NIH Grant/Contract Award Number )
Study First Received: February 28, 2017
Last Updated: March 10, 2017
Individual Participant Data  
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Emory University:
Prostate cancer
Metastatic cancer
Urogenital disorders
Oncology
Radiology

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases

ClinicalTrials.gov processed this record on March 24, 2017