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

• Sponsor: Emory University (Other)
• Overall Status: Completed
• CT.gov ID: NCT03081884
• Collaborator: National Cancer Institute (NCI) (NIH)
• Enrollment: 61
• Location: 1
• Arm: 1
• Actual Duration (Months): 34
• Patients Per Site Per Month: 1.8

Study Details

Study Description

Brief 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 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 or Disease	Intervention/Treatment	Phase
Cancer	Drug: FACBC PET-CT Imaging	Phase 2

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

• Study Type: Interventional
• Actual Enrollment: 61 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Intervention Model Description: All participants will have the same interventionAll 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: Mar 1, 2017
• Actual Primary Completion Date: Dec 31, 2019
• Actual Study Completion Date: Dec 31, 2019

Arms and Interventions

Arm

Intervention/Treatment

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 Names: Fluciclovine

Outcome Measures

Primary Outcome Measures

1. Cancer Detection Performance of FACBC PET/CT [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.

Secondary Outcome Measures

1. Diagnostic Performance of FACBC PET/CT and Conventional Imaging [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	Emory University Hospital	Atlanta	Georgia	United States	30322

Sponsors and Collaborators

• Emory University
• National Cancer Institute (NCI)

Investigators

• Principal Investigator: Mehrdad Alemozaffar, Emory University
• Principal Investigator: David M Schuster, MD, Emory University

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Jun 30, 2017

More Information

Publications

None provided.

• Responsible Party: David M Schuster, Professor, Emory University
• ClinicalTrials.gov Identifier: NCT03081884
• Other Study ID Numbers: IRB00092595; U01CA113913-11
• First Posted: Mar 16, 2017
• Last Update Posted: Jan 25, 2021
• Last Verified: Jan 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• 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 David M Schuster, Professor, Emory University: Prostate cancer; Metastatic cancer; Urogenital disorders; Oncology; Radiology
• Additional relevant MeSH terms: Prostatic Neoplasms

Study Results

Participant Flow

Recruitment Details	Participant enrollment began March 1, 2017 and all study follow-up was completed by December 31, 2019. Participants were enrolled from the patient population at Emory University Hospital in Atlanta, Georgia.

Arm/Group Title	FACBC PET-CT Imaging
Arm/Group Description	Individuals diagnosed with primary prostate carcinoma and without definitive findings of systemic metastasis with conventional imaging, had a whole body FACBC positron emission tomography (PET)-computerized tomography (CT)(PET-CT) scan followed by robotic radical prostatectomy with extended pelvic lymph node dissection.
Period Title: Overall Study
STARTED	61
COMPLETED	57
NOT COMPLETED	4

Baseline Characteristics

Arm/Group Title	FACBC PET-CT Imaging
Arm/Group Description	Individuals diagnosed with primary prostate carcinoma and without definitive findings of systemic metastasis with conventional imaging, had a whole body FACBC positron emission tomography (PET)-computerized tomography (CT)(PET-CT) scan followed by robotic radical prostatectomy with extended pelvic lymph node dissection.
Overall Participants	57
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	61.7 (7.0)
Sex: Female, Male (Count of Participants)
Female	0 0%
Male	57 100%
Race and Ethnicity Not Collected (Count of Participants)
Region of Enrollment (Count of Participants)
United States	57 100%
Type of Standard of Care Imaging (Count of Participants)
Computerized tomography (CT)	20 35.1%
Magnetic resonance imaging (MRI)	37 64.9%

Outcome Measures

1. Primary Outcome

Title	Cancer Detection Performance of FACBC PET/CT
Description	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.
Time Frame	Day 1

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	FACBC PET-CT Imaging
Arm/Group Description	Individuals diagnosed with primary prostate carcinoma and without definitive findings of systemic metastasis with conventional imaging, had a whole body FACBC PET-CT scan followed by robotic radical prostatectomy with extended pelvic lymph node dissection.
Measure Participants	57
True positive	17 29.8%
True negative	22 38.6%
False positive	4 7%
False negative	14 24.6%

2. Secondary Outcome

Title	Diagnostic Performance of FACBC PET/CT and Conventional Imaging
Description	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.
Time Frame	Day 1, Day of surgery

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	FACBC PET-CT Imaging	Conventional Imaging
Arm/Group Description	Individuals diagnosed with primary prostate carcinoma and without definitive findings of systemic metastasis with conventional imaging, had a whole body FACBC PET-CT scan followed by robotic radical prostatectomy with extended pelvic lymph node dissection.	Study participants also had conventional imaging (CT or MRI) as part of standard of care.
Measure Participants	57	57
Sensitivity	55.3 97%	33.3 NaN
Specificity	84.8 148.8%	84.1 NaN
Positive predictive value	81.5 143%	72.2 NaN
Negative predictive value	60.8 106.7%	51.2 NaN
Accuracy	68.5 120.2%	56.3 NaN

Adverse Events

Time Frame	Adverse events were documented beginning at the time when the radiotracer was administered and ending 7 days after administration.
Arm/Group Title	FACBC PET-CT Imaging
Arm/Group Description	Individuals diagnosed with primary prostate carcinoma and without definitive findings of systemic metastasis with conventional imaging, had a whole body FACBC positron emission tomography (PET)-computerized tomography (CT)(PET-CT) scan followed by robotic radical prostatectomy with extended pelvic lymph node dissection.
All Cause Mortality
	FACBC PET-CT Imaging
	Affected / at Risk (%)	# Events
Total	0/57 (0%)
Serious Adverse Events
	FACBC PET-CT Imaging
	Affected / at Risk (%)	# Events
Total	0/57 (0%)
Other (Not Including Serious) Adverse Events
	FACBC PET-CT Imaging
	Affected / at Risk (%)	# Events
Total	0/57 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.