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FACBC PET/CT for Recurrent Prostate Cancer

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ClinicalTrials.gov Identifier: NCT00562315
Recruitment Status : Completed
First Posted : November 22, 2007
Results First Posted : August 18, 2015
Last Update Posted : June 21, 2016
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
David M. Schuster, MD, Emory University

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: Single (Investigator);   Primary Purpose: Diagnostic
Condition Prostate Cancer
Interventions Drug: FACBC
Other: ProstaScinct
Enrollment 128
Recruitment Details The study was completed November 28,2007 through July 10, 2012.
Pre-assignment Details Of the 128 participants consented, 93 participants met the criteria to receive the ProstaScint (In-capromab pendetide) and the FACBC (anti-3-[18F]) scans. 115 participants had FACBC scans, with 13 receiving repeat scans. Therefore, excluding 13 participants. 93 participants had one FACBC scan and one ProstaScint scan and did not have repeat scans.
Arm/Group Title FACBC PET-CT and ProstaScint CT
Hide Arm/Group Description Participants diagnosed with localized prostate carcinoma with subsequent definitive therapy or suspicion of recurrent cancer underwent an FACBC PET-CT scan and the ProstaScinct CT.
Period Title: Overall Study
Started 93
Completed 93
Not Completed 0
Arm/Group Title FACBC PET-CT and ProstaScint CT
Hide Arm/Group Description Participants diagnosed with localized prostate carcinoma with subsequent definitive therapy or suspicion of recurrent cancer underwent an FACBC PET-CT scan and the ProstaScinct CT.
Overall Number of Baseline Participants 93
Hide Baseline Analysis Population Description
Participants completed both the FACBC PET-CT and the ProstaScint CT.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 93 participants
68.0  (7.6)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 93 participants
Female
0
   0.0%
Male
93
 100.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 93 participants
93
1.Primary Outcome
Title Number of Participants With True Positive Scans Within the Prostate Bed
Hide Description Total number of participants with positive FACBC PET-CT and ProstaScint CT scans in diagnosis of prostate cancer in the prostate bed validated by prostate biopsy and follow up.
Time Frame Up to 5 years
Hide Outcome Measure Data
Hide Analysis Population Description
91 participants had sufficient data to determine disease presence or absence in the prostate bed.
Arm/Group Title FACBC PET-CT and ProstaScint CT
Hide Arm/Group Description:
Participants diagnosed with localized prostate carcinoma with subsequent definitive therapy or suspicion of recurrent cancer underwent an FACBC PET-CT scan and the ProstaScinct CT.
Overall Number of Participants Analyzed 91
Measure Type: Number
Unit of Measure: participants
FACBC PET-CT 55
ProstaScint CT 41
2.Primary Outcome
Title Number of Participants With False Positive Scans Within the Prostate Bed
Hide Description Total number of participants with positive FACBC PET-CT and ProstaScint scans in the prostate bed that were confirmed as negative by biopsy and or follow up.
Time Frame Up to 5 years
Hide Outcome Measure Data
Hide Analysis Population Description
91 participants had sufficient data to determine disease presence or absence in the prostate bed.
Arm/Group Title FACBC PET-CT and ProstaScint CT
Hide Arm/Group Description:
Participants diagnosed with localized prostate carcinoma with subsequent definitive therapy or suspicion of recurrent cancer underwent an FACBC PET-CT scan and the ProstaScinct CT.
Overall Number of Participants Analyzed 91
Measure Type: Number
Unit of Measure: participants
FACBC PET-CT 18
ProstaScint CT 13
3.Primary Outcome
Title Number of Participants With True Negative Scans Within the Prostate Bed
Hide Description Total number of participants with negative FACBC PET-CT and ProstaScint CT scans in the prostate bed that were confirmed as negative by biopsy and or follow up.
Time Frame Up to 5 years
Hide Outcome Measure Data
Hide Analysis Population Description
91 participants had sufficient data to determine disease presence or absence in the prostate bed.
Arm/Group Title FACBC PET-CT and ProstaScint CT
Hide Arm/Group Description:
Participants diagnosed with localized prostate carcinoma with subsequent definitive therapy or suspicion of recurrent cancer underwent an FACBC PET-CT scan and the ProstaScinct CT.
Overall Number of Participants Analyzed 91
Measure Type: Number
Unit of Measure: participants
FACBC PET-CT 12
ProstaScint CT 17
4.Primary Outcome
Title Number of Participants With False Negative Scans Within the Prostate Bed
Hide Description Total number of participants with negative FACBC PET-CT and ProstaScint CT scans in the prostate bed that were confirmed as positive by biopsy and or follow up.
Time Frame Up to 5 years
Hide Outcome Measure Data
Hide Analysis Population Description
91 participants had sufficient data to determine disease presence or absence in the prostate bed.
Arm/Group Title FACBC PET-CT and ProstaScint CT
Hide Arm/Group Description:
Participants diagnosed with localized prostate carcinoma with subsequent definitive therapy or suspicion of recurrent cancer underwent an FACBC PET-CT scan and the ProstaScinct CT.
Overall Number of Participants Analyzed 91
Measure Type: Number
Unit of Measure: participants
FACBC PET-CT 6
ProstaScint CT 20
5.Primary Outcome
Title Number of Participants With True Positive Scans Outside the Prostate Bed
Hide Description Total number of participants with positive FACBC PET-CT and ProstaScint CT scans outside the prostate bed (extra-prostate) that were confirmed as positive by biopsy and/or follow up.
Time Frame Up to 5 years
Hide Outcome Measure Data
Hide Analysis Population Description
There was sufficient data for 70 participants to determine disease presence or absence at extraprostatic locations.
Arm/Group Title FACBC PET-CT and ProstaScint CT
Hide Arm/Group Description:
Participants diagnosed with localized prostate carcinoma with subsequent definitive therapy or suspicion of recurrent cancer underwent an FACBC PET-CT scan and the ProstaScinct CT.
Overall Number of Participants Analyzed 70
Measure Type: Number
Unit of Measure: participants
FACBC PET-CT 22
ProstaScint CT 4
6.Primary Outcome
Title Number of Participants With True Negative Scans Outside the Prostate Bed
Hide Description Total number of participants with negative FACBC PET-CT and ProstaScint CT scans outside the prostate bed (extra-prostate) that were confirmed as negative by biopsy and/or follow up.
Time Frame Up to 5 years
Hide Outcome Measure Data
Hide Analysis Population Description
There was sufficient data for 70 participants to determine disease presence or absence at extraprostatic locations.
Arm/Group Title FACBC PET-CT and ProstaScint CT
Hide Arm/Group Description:
Participants diagnosed with localized prostate carcinoma with subsequent definitive therapy or suspicion of recurrent cancer underwent an FACBC PET-CT scan and the ProstaScinct CT.
Overall Number of Participants Analyzed 70
Measure Type: Number
Unit of Measure: participants
FACBC PET-CT 29
ProstaScint CT 26
7.Primary Outcome
Title Number of Participants With False Positive Scans Outside the Prostate Bed
Hide Description Total number of participants with positive FACBC PET-CT and ProstaScint CT scans outside the prostate bed (extra-prostate) that were confirmed as negative by biopsy and/or follow up.
Time Frame Up to 5 years
Hide Outcome Measure Data
Hide Analysis Population Description
There was sufficient data for 70 participants to determine disease presence or absence at extraprostatic locations.
Arm/Group Title FACBC PET-CT and ProstaScint CT
Hide Arm/Group Description:
Participants diagnosed with localized prostate carcinoma with subsequent definitive therapy or suspicion of recurrent cancer underwent an FACBC PET-CT scan and the ProstaScinct CT.
Overall Number of Participants Analyzed 70
Measure Type: Number
Unit of Measure: participants
FACBC PET-CT 1
ProstaScint CT 4
8.Primary Outcome
Title Number of Participants With False Negative Scans Outside the Prostate Bed
Hide Description Total number of participants with negative FACBC PET-CT and ProstaScint CT scans outside the prostate bed (extra-prostate) that were confirmed as positive by biopsy and/or follow up.
Time Frame Up to 5 years
Hide Outcome Measure Data
Hide Analysis Population Description
There was sufficient data for 70 participants to determine disease presence or absence at extraprostatic locations.
Arm/Group Title FACBC PET-CT and ProstaScint CT
Hide Arm/Group Description:
Participants diagnosed with localized prostate carcinoma with subsequent definitive therapy or suspicion of recurrent cancer underwent an FACBC PET-CT scan and the ProstaScinct CT.
Overall Number of Participants Analyzed 70
Measure Type: Number
Unit of Measure: participants
FACBC PET-CT 18
ProstaScint CT 36
9.Primary Outcome
Title Diagnostic Performance of Anti-[18F]FACBC PET-CT Imaging in Detection of Extra-prostatic Recurrence of Prostate Carcinoma
Hide Description
  1. Sensitivity = How well FACBC PET is able to correctly detect when there is prostate cancer outside the prostate bed. [total number of true positives / total number of study participants confirmed to have prostate cancer outside the prostate bed (True positives + False negatives)]
  2. Specificity = How well FACBC PET is able to correctly detect when there is no prostate cancer outside the prostate bed. [ total number of true negatives / total number of study participants confirmed to not have prostate cancer outside the prostate bed (True negatives + False positives)]
  3. Accuracy = (True positives + true negatives)/all tests
  4. Positive predictive value = probability that subjects with a positive screening test truly have prostate cancer outside the prostate bed
  5. Negative predictive value = probability that subjects with a negative screening test truly don't have prostate cancer outside the prostate bed
Time Frame Up to 5 years
Hide Outcome Measure Data
Hide Analysis Population Description
Participants with a definitive consensus for the presence or absence of extraprostatic disease.
Arm/Group Title FACBC PET/CT for Recurrent Prostate Cancer
Hide Arm/Group Description:

This is a single arm study

[18F]FACBC: [18F]FACBC is given intravenously prior to PET scan

Overall Number of Participants Analyzed 70
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of true tests
% Sensitivity
55.0
(38.5 to 70.7)
% Specificity
96.7
(82.8 to 99.9)
% Accuracy
72.9
(60.9 to 82.8)
% Positive Predictive Value
95.7
(78.1 to 99.9)
% Negative Predictive Value
61.7
(46.4 to 75.5)
10.Primary Outcome
Title Diagnostic Performance of Anti-[18F]FACBC PET-CT Imaging in Detection of Recurrent Prostate Carcinoma in the Prostate Bed
Hide Description
  1. Sensitivity = How well FACBC PET is able to correctly detect when there is prostate cancer in the prostate bed. i.e. total number of true positives / total number of study participants confirmed to have prostate disease in the prostate bed (True positives + False negatives)
  2. Specificity = How well FACBC PET is able to correctly detect when there is no prostate cancer in the prostate bed. i.e. total number of true negatives / total number of study participants confirmed to not have prostate disease in the prostate bed (True negatives + False positives)
  3. Accuracy = (True positives + true negatives)/all tests
  4. Positive predictive value = the probability that subjects with a positive screening test truly have prostate carcinoma in the prostate bed
  5. Negative predictive value = the probability that subjects with a negative screening test truly don't have prostate carcinoma in the prostate bed
Time Frame Up to 5 years
Hide Outcome Measure Data
Hide Analysis Population Description
Participants with a definitive consensus on the presence or absence of prostatic/bed disease.
Arm/Group Title FACBC PET/CT for Recurrent Prostate Cancer
Hide Arm/Group Description:
Participants diagnosed with localized prostate carcinoma with subsequent definitive therapy or suspicion of recurrent cancer underwent an FACBC PET-CT scan and the ProstaScinct CT.
Overall Number of Participants Analyzed 91
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of true tests
% Sensitivity
90.2
(79.8 to 96.3)
% Specificity
40.0
(22.7 to 59.4)
% Accuracy
73.6
(63.3 to 82.3)
% Positive Predictive Value
75.3
(63.9 to 84.7)
% Negative Predictive Value
66.7
(41.0 to 86.7)
11.Secondary Outcome
Title Diagnostic Performance of ProstaScint Imaging in Detection of Recurrent Prostate Carcinoma in the Prostate Bed
Hide Description
  1. Sensitivity = How well ProstaScint imaging is able to correctly detect when there is prostate cancer in the prostate bed. i.e. total number of true positives / total number of study participants confirmed to have prostate disease in the prostate bed (True positives + False negatives)
  2. Specificity = How well ProstaScint imaging is able to correctly detect when there is no prostate cancer in the prostate bed. i.e. total number of true negatives / total number of study participants confirmed to not have prostate disease in the prostate bed (True negatives + False positives)
  3. Accuracy = (True positives + true negatives)/all tests
  4. Positive predictive value = the probability that subjects with a positive screening test truly have prostate carcinoma in the prostate bed
  5. Negative predictive value = the probability that subjects with a negative screening test truly don't have prostate carcinoma in the prostate bed
Time Frame Up to 5 years
Hide Outcome Measure Data
Hide Analysis Population Description
Participants with a definitive consensus on the presence or absence of prostatic/bed disease.
Arm/Group Title FACBC PET/CT for Recurrent Prostate Cancer
Hide Arm/Group Description:
Participants diagnosed with localized prostate carcinoma with subsequent definitive therapy or suspicion of recurrent cancer underwent an FACBC PET-CT scan and the ProstaScinct CT.
Overall Number of Participants Analyzed 91
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of true tests
% Sensitivity
67.2
(54.0 to 78.7)
% Specificity
56.7
(37.4 to 74.5)
% Accuracy
63.7
(53.0 to 73.6)
% Positive Predictive Value
75.9
(62.4 to 86.5)
% Negative Predictive Value
45.9
(29.5 to 63.1)
12.Secondary Outcome
Title Diagnostic Performance of ProstaScint Imaging in Detection of Extra-prostatic Recurrence of Prostate Carcinoma
Hide Description
  1. Sensitivity = How well ProstaScint is able to correctly detect when there is prostate cancer outside the prostate bed. [total number of true positives / total number of study participants confirmed to have prostate cancer outside the prostate bed (True positives + False negatives)]
  2. Specificity = How well ProstaScint is able to correctly detect when there is no prostate cancer outside the prostate bed. [ total number of true negatives / total number of study participants confirmed to not have prostate cancer outside the prostate bed (True negatives + False positives)]
  3. Accuracy = (True positives + true negatives)/all tests
  4. Positive predictive value = the probability that subjects with a positive screening test truly have prostate cancer outside the prostate bed
  5. Negative predictive value is the probability that subjects with a negative screening test truly don't have prostate cancer outside the prostate bed
Time Frame Up to 5 years
Hide Outcome Measure Data
Hide Analysis Population Description
Participants with a definitive consensus for the presence or absence of extraprostatic disease.
Arm/Group Title FACBC PET-CT and ProstaScint CT
Hide Arm/Group Description:
Participants diagnosed with localized prostate carcinoma with subsequent definitive therapy or suspicion of recurrent cancer underwent an FACBC PET-CT scan and the ProstaScinct CT.
Overall Number of Participants Analyzed 70
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of true tests
% Sensitivity
10.0
(2.8 to 23.7)
% Specificity
86.7
(69.3 to 96.2)
% Accuracy
42.9
(31.1 to 55.3)
% Positive Predictive Value
50.0
(15.7 to 84.3)
% Negative Predictive Value
41.9
(29.5 to 55.2)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title FACBC PET-CT and ProstaScint CT
Hide Arm/Group Description All participants who received scans, including repeat scans, were monitored for adverse events.
All-Cause Mortality
FACBC PET-CT and ProstaScint CT
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
FACBC PET-CT and ProstaScint CT
Affected / at Risk (%)
Total   0/115 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
FACBC PET-CT and ProstaScint CT
Affected / at Risk (%)
Total   0/115 (0.00%) 
Certain Agreements
Principal Investigators are NOT 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.
Results Point of Contact
Name/Title: David M. Schuster, MD
Organization: Emory University
Phone: 404-712-4859
Responsible Party: David M. Schuster, MD, Emory University
ClinicalTrials.gov Identifier: NCT00562315     History of Changes
Other Study ID Numbers: IRB00006468
R01CA129356-01 ( U.S. NIH Grant/Contract )
First Submitted: November 20, 2007
First Posted: November 22, 2007
Results First Submitted: July 23, 2015
Results First Posted: August 18, 2015
Last Update Posted: June 21, 2016