Validation of FACBC for Detection of Metastasis Among High-risk Prostate Cancer Patients With Presumed Localized Disease (EDRN-FACBC)
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| ClinicalTrials.gov Identifier: NCT03081884 |
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Recruitment Status :
Completed
First Posted : March 16, 2017
Results First Posted : January 25, 2021
Last Update Posted : January 25, 2021
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Cancer | Drug: FACBC PET-CT Imaging | Phase 2 |
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 Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 61 participants |
| Allocation: | N/A |
| Intervention Model: | Single Group Assignment |
| Intervention Model Description: | All participants will have the same intervention |
| Masking: | None (Open Label) |
| 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 |
| Actual Study Start Date : | March 1, 2017 |
| Actual Primary Completion Date : | December 31, 2019 |
| Actual Study Completion Date : | December 31, 2019 |
| Arm | Intervention/treatment |
|---|---|
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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.
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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 |
- 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.
- Diagnostic Performance of FACBC PET/CT and Conventional Imaging [ Time Frame: Day 1, Day of surgery ]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.
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
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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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03081884
| United States, Georgia | |
| Emory University Hospital | |
| Atlanta, Georgia, United States, 30322 | |
| Principal Investigator: | Mehrdad Alemozaffar | Emory University | |
| Principal Investigator: | David M Schuster, MD | Emory University |
Documents provided by David M Schuster, Emory University:
| Responsible Party: | David M Schuster, Professor, Emory University |
| ClinicalTrials.gov Identifier: | NCT03081884 |
| Other Study ID Numbers: |
IRB00092595 U01CA113913-11 ( U.S. NIH Grant/Contract ) |
| First Posted: | March 16, 2017 Key Record Dates |
| Results First Posted: | January 25, 2021 |
| Last Update Posted: | January 25, 2021 |
| Last Verified: | January 2021 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
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Prostate cancer Metastatic cancer Urogenital disorders Oncology Radiology |
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Prostatic Neoplasms Genital Neoplasms, Male Urogenital Neoplasms |
Neoplasms by Site Neoplasms Prostatic Diseases |