Trial Outcomes & Findings for Targeted Fusion Biopsy of the Prostate (NCT NCT02744534)
NCT ID: NCT02744534
Last Updated: 2019-05-08
Results Overview
The cancer detection rate per core was compared between the targeted prostate biopsy and standard of care prostate biopsy.
COMPLETED
PHASE2
21 participants
Two weeks
2019-05-08
Participant Flow
Participants were recruited from Emory University Hospital and the Winship Cancer Institute in Atlanta, Georgia from November 2015 to April 2017. All study procedures were completed by March 31, 2018.
Participants with abnormal anti-1-amino-3-\[18F\]fluorocyclobutane-1- carboxylic acid (FACBC) positron emission tomography (PET)-CT scans were to have both targeted and template biopsies while those with normal FACBC PET-CT scans would have only the standard of care template biopsy. None of the study participants had a normal FACBC PET-CT scan.
Participant milestones
| Measure |
Targeted Biopsy and Template Biopsy
Study participants with abnormal FACBC PET-CT scans received a fluciclovine PET ultrasound fusion targeted biopsy and a template (standard of care) biopsy to test for recurrent prostate cancer.
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|---|---|
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Overall Study
STARTED
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21
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Overall Study
COMPLETED
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21
|
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Overall Study
NOT COMPLETED
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0
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Targeted Biopsy and Template Biopsy
n=21 Participants
Study participants with abnormal FACBC PET-CT scans received a targeted biopsy and a template (standard of care) biopsy to test for recurrent prostate cancer.
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|---|---|
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Age, Continuous
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69.6 years
STANDARD_DEVIATION 7.4 • n=21 Participants
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Sex: Female, Male
Female
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0 Participants
n=21 Participants
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Sex: Female, Male
Male
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21 Participants
n=21 Participants
|
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Region of Enrollment
United States
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21 Participants
n=21 Participants
|
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Prostate-Specific Antigen (PSA) prior to PET scan
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7.4 ng/ml
STANDARD_DEVIATION 6.8 • n=21 Participants
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Initial therapy
Radiotherapy
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9 Participants
n=21 Participants
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Initial therapy
Non-radiotherapy (cryotherapy)
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3 Participants
n=21 Participants
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Initial therapy
Mixed therapy
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9 Participants
n=21 Participants
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PRIMARY outcome
Timeframe: Two weeksPopulation: All 21 participants are included in the analysis, and all participants had both types of biopsies performed. The total number of core samples taken during biopsy are given as the overall number of participants analyzed and the percentage of these core samples that tested positive for prostate cancer are given as the outcome measure data.
The cancer detection rate per core was compared between the targeted prostate biopsy and standard of care prostate biopsy.
Outcome measures
| Measure |
Targeted Biopsy
n=125 Prostate biopsy core samples
Fluciclovine defined targets were biopsied using the 3-D visualization and navigation platform to guide the biopsy needle and record its path.
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Standard Biopsy
n=246 Prostate biopsy core samples
The standard transrectal ultrasound guided biopsy collects 2 cores per region (when possible) from 6 standard regions of the prostate.
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|---|---|---|
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Percentage of Cores Positive for Cancer
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32.0 percentage of positive core samples
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4.5 percentage of positive core samples
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Adverse Events
Targeted Biopsy
Template Biopsy
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place