Trial Outcomes & Findings for Validation of FACBC for Detection of Metastasis Among High-risk Prostate Cancer Patients With Presumed Localized Disease (NCT NCT03081884)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

61 participants

Primary outcome timeframe

Day 1

Results posted on

2021-01-25

Participant Flow

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.

Participant milestones

Participant milestones
Measure	FACBC PET-CT Imaging 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 Study STARTED	61
Overall Study COMPLETED	57
Overall Study NOT COMPLETED	4

Reasons for withdrawal

Reasons for withdrawal
Measure	FACBC PET-CT Imaging 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 Study deferred prostate cancer treatment	1
Overall Study metastasis managed with systemic therapy	3

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	FACBC PET-CT Imaging n=57 Participants 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.
Age, Continuous	61.7 years STANDARD_DEVIATION 7.0 • n=57 Participants
Sex: Female, Male Female	0 Participants n=57 Participants
Sex: Female, Male Male	57 Participants n=57 Participants
Region of Enrollment United States	57 Participants n=57 Participants
Type of Standard of Care Imaging Computerized tomography (CT)	20 Participants n=57 Participants
Type of Standard of Care Imaging Magnetic resonance imaging (MRI)	37 Participants n=57 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	FACBC PET-CT Imaging n=57 Participants 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.	Conventional Imaging Study participants also had conventional imaging (CT or MRI) as part of standard of care.
Cancer Detection Performance of FACBC PET/CT True positive	17 Participants	—
Cancer Detection Performance of FACBC PET/CT True negative	22 Participants	—
Cancer Detection Performance of FACBC PET/CT False positive	4 Participants	—
Cancer Detection Performance of FACBC PET/CT False negative	14 Participants	—

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	FACBC PET-CT Imaging n=57 Participants 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.	Conventional Imaging n=57 Participants Study participants also had conventional imaging (CT or MRI) as part of standard of care.
Diagnostic Performance of FACBC PET/CT and Conventional Imaging Sensitivity	55.3 percentage of participants Interval 43.0 to 68.0	33.3 percentage of participants Interval 21.0 to 47.0
Diagnostic Performance of FACBC PET/CT and Conventional Imaging Specificity	84.8 percentage of participants Interval 75.0 to 94.7	84.1 percentage of participants Interval 73.3 to 94.4
Diagnostic Performance of FACBC PET/CT and Conventional Imaging Positive predictive value	81.5 percentage of participants Interval 69.2 to 93.3	72.2 percentage of participants Interval 55.6 to 88.9
Diagnostic Performance of FACBC PET/CT and Conventional Imaging Negative predictive value	60.8 percentage of participants Interval 47.8 to 73.7	51.2 percentage of participants Interval 40.0 to 63.0
Diagnostic Performance of FACBC PET/CT and Conventional Imaging Accuracy	68.5 percentage of participants Interval 59.4 to 78.1	56.3 percentage of participants Interval 47.2 to 65.7

Adverse Events

FACBC PET-CT Imaging

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

David M. Schuster, MD

Emory University

Phone: 404-712-4859

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place