Trial Outcomes & Findings for FACBC PET/CT for Recurrent Prostate Cancer (NCT NCT00562315)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

128 participants

Primary outcome timeframe

Up to 5 years

Results posted on

2016-06-21

Participant Flow

The study was completed November 28,2007 through July 10, 2012.

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.

Participant milestones

Participant milestones
Measure	FACBC PET-CT and ProstaScint CT 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 Study STARTED	93
Overall Study COMPLETED	93
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

FACBC PET/CT for Recurrent Prostate Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	FACBC PET-CT and ProstaScint CT n=93 Participants 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.
Age, Continuous	68.0 years STANDARD_DEVIATION 7.6 • n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	93 Participants n=5 Participants
Region of Enrollment United States	93 participants n=5 Participants

PRIMARY outcome

Timeframe: Up to 5 years

Population: 91 participants had sufficient data to determine disease presence or absence in the prostate bed.

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.

Outcome measures

Outcome measures
Measure	FACBC PET-CT and ProstaScint CT n=91 Participants 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.
Number of Participants With True Positive Scans Within the Prostate Bed FACBC PET-CT	55 participants
Number of Participants With True Positive Scans Within the Prostate Bed ProstaScint CT	41 participants

PRIMARY outcome

Timeframe: Up to 5 years

Population: 91 participants had sufficient data to determine disease presence or absence in the prostate bed.

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.

Outcome measures

Outcome measures
Measure	FACBC PET-CT and ProstaScint CT n=91 Participants 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.
Number of Participants With False Positive Scans Within the Prostate Bed FACBC PET-CT	18 participants
Number of Participants With False Positive Scans Within the Prostate Bed ProstaScint CT	13 participants

PRIMARY outcome

Timeframe: Up to 5 years

Population: 91 participants had sufficient data to determine disease presence or absence in the prostate bed.

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.

Outcome measures

Outcome measures
Measure	FACBC PET-CT and ProstaScint CT n=91 Participants 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.
Number of Participants With True Negative Scans Within the Prostate Bed FACBC PET-CT	12 participants
Number of Participants With True Negative Scans Within the Prostate Bed ProstaScint CT	17 participants

PRIMARY outcome

Timeframe: Up to 5 years

Population: 91 participants had sufficient data to determine disease presence or absence in the prostate bed.

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.

Outcome measures

Outcome measures
Measure	FACBC PET-CT and ProstaScint CT n=91 Participants 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.
Number of Participants With False Negative Scans Within the Prostate Bed FACBC PET-CT	6 participants
Number of Participants With False Negative Scans Within the Prostate Bed ProstaScint CT	20 participants

PRIMARY outcome

Timeframe: Up to 5 years

Population: There was sufficient data for 70 participants to determine disease presence or absence at extraprostatic locations.

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.

Outcome measures

Outcome measures
Measure	FACBC PET-CT and ProstaScint CT n=70 Participants 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.
Number of Participants With True Positive Scans Outside the Prostate Bed FACBC PET-CT	22 participants
Number of Participants With True Positive Scans Outside the Prostate Bed ProstaScint CT	4 participants

PRIMARY outcome

Timeframe: Up to 5 years

Population: There was sufficient data for 70 participants to determine disease presence or absence at extraprostatic locations.

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.

Outcome measures

Outcome measures
Measure	FACBC PET-CT and ProstaScint CT n=70 Participants 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.
Number of Participants With True Negative Scans Outside the Prostate Bed FACBC PET-CT	29 participants
Number of Participants With True Negative Scans Outside the Prostate Bed ProstaScint CT	26 participants

PRIMARY outcome

Timeframe: Up to 5 years

Population: There was sufficient data for 70 participants to determine disease presence or absence at extraprostatic locations.

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.

Outcome measures

Outcome measures
Measure	FACBC PET-CT and ProstaScint CT n=70 Participants 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.
Number of Participants With False Positive Scans Outside the Prostate Bed FACBC PET-CT	1 participants
Number of Participants With False Positive Scans Outside the Prostate Bed ProstaScint CT	4 participants

PRIMARY outcome

Timeframe: Up to 5 years

Population: There was sufficient data for 70 participants to determine disease presence or absence at extraprostatic locations.

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.

Outcome measures

Outcome measures
Measure	FACBC PET-CT and ProstaScint CT n=70 Participants 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.
Number of Participants With False Negative Scans Outside the Prostate Bed FACBC PET-CT	18 participants
Number of Participants With False Negative Scans Outside the Prostate Bed ProstaScint CT	36 participants

PRIMARY outcome

Timeframe: Up to 5 years

Population: Participants with a definitive consensus for the presence or absence of extraprostatic disease.

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

Outcome measures

Outcome measures
Measure	FACBC PET-CT and ProstaScint CT n=70 Participants 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.
Diagnostic Performance of Anti-[18F]FACBC PET-CT Imaging in Detection of Extra-prostatic Recurrence of Prostate Carcinoma % Sensitivity	55.0 percentage of true tests Interval 38.5 to 70.7
Diagnostic Performance of Anti-[18F]FACBC PET-CT Imaging in Detection of Extra-prostatic Recurrence of Prostate Carcinoma % Specificity	96.7 percentage of true tests Interval 82.8 to 99.9
Diagnostic Performance of Anti-[18F]FACBC PET-CT Imaging in Detection of Extra-prostatic Recurrence of Prostate Carcinoma % Accuracy	72.9 percentage of true tests Interval 60.9 to 82.8
Diagnostic Performance of Anti-[18F]FACBC PET-CT Imaging in Detection of Extra-prostatic Recurrence of Prostate Carcinoma % Positive Predictive Value	95.7 percentage of true tests Interval 78.1 to 99.9
Diagnostic Performance of Anti-[18F]FACBC PET-CT Imaging in Detection of Extra-prostatic Recurrence of Prostate Carcinoma % Negative Predictive Value	61.7 percentage of true tests Interval 46.4 to 75.5

PRIMARY outcome

Timeframe: Up to 5 years

Population: Participants with a definitive consensus on the presence or absence of prostatic/bed disease.

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

Outcome measures

Outcome measures
Measure	FACBC PET-CT and ProstaScint CT n=91 Participants 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.
Diagnostic Performance of Anti-[18F]FACBC PET-CT Imaging in Detection of Recurrent Prostate Carcinoma in the Prostate Bed % Sensitivity	90.2 percentage of true tests Interval 79.8 to 96.3
Diagnostic Performance of Anti-[18F]FACBC PET-CT Imaging in Detection of Recurrent Prostate Carcinoma in the Prostate Bed % Specificity	40.0 percentage of true tests Interval 22.7 to 59.4
Diagnostic Performance of Anti-[18F]FACBC PET-CT Imaging in Detection of Recurrent Prostate Carcinoma in the Prostate Bed % Accuracy	73.6 percentage of true tests Interval 63.3 to 82.3
Diagnostic Performance of Anti-[18F]FACBC PET-CT Imaging in Detection of Recurrent Prostate Carcinoma in the Prostate Bed % Positive Predictive Value	75.3 percentage of true tests Interval 63.9 to 84.7
Diagnostic Performance of Anti-[18F]FACBC PET-CT Imaging in Detection of Recurrent Prostate Carcinoma in the Prostate Bed % Negative Predictive Value	66.7 percentage of true tests Interval 41.0 to 86.7

SECONDARY outcome

Timeframe: Up to 5 years

Population: Participants with a definitive consensus on the presence or absence of prostatic/bed disease.

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

Outcome measures

Outcome measures
Measure	FACBC PET-CT and ProstaScint CT n=91 Participants 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.
Diagnostic Performance of ProstaScint Imaging in Detection of Recurrent Prostate Carcinoma in the Prostate Bed % Sensitivity	67.2 percentage of true tests Interval 54.0 to 78.7
Diagnostic Performance of ProstaScint Imaging in Detection of Recurrent Prostate Carcinoma in the Prostate Bed % Specificity	56.7 percentage of true tests Interval 37.4 to 74.5
Diagnostic Performance of ProstaScint Imaging in Detection of Recurrent Prostate Carcinoma in the Prostate Bed % Accuracy	63.7 percentage of true tests Interval 53.0 to 73.6
Diagnostic Performance of ProstaScint Imaging in Detection of Recurrent Prostate Carcinoma in the Prostate Bed % Positive Predictive Value	75.9 percentage of true tests Interval 62.4 to 86.5
Diagnostic Performance of ProstaScint Imaging in Detection of Recurrent Prostate Carcinoma in the Prostate Bed % Negative Predictive Value	45.9 percentage of true tests Interval 29.5 to 63.1

SECONDARY outcome

Timeframe: Up to 5 years

Population: Participants with a definitive consensus for the presence or absence of extraprostatic disease.

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

Outcome measures

Outcome measures
Measure	FACBC PET-CT and ProstaScint CT n=70 Participants 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.
Diagnostic Performance of ProstaScint Imaging in Detection of Extra-prostatic Recurrence of Prostate Carcinoma % Sensitivity	10.0 percentage of true tests Interval 2.8 to 23.7
Diagnostic Performance of ProstaScint Imaging in Detection of Extra-prostatic Recurrence of Prostate Carcinoma % Specificity	86.7 percentage of true tests Interval 69.3 to 96.2
Diagnostic Performance of ProstaScint Imaging in Detection of Extra-prostatic Recurrence of Prostate Carcinoma % Accuracy	42.9 percentage of true tests Interval 31.1 to 55.3
Diagnostic Performance of ProstaScint Imaging in Detection of Extra-prostatic Recurrence of Prostate Carcinoma % Positive Predictive Value	50.0 percentage of true tests Interval 15.7 to 84.3
Diagnostic Performance of ProstaScint Imaging in Detection of Extra-prostatic Recurrence of Prostate Carcinoma % Negative Predictive Value	41.9 percentage of true tests Interval 29.5 to 55.2

Adverse Events

FACBC PET-CT and ProstaScint CT

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