Trial Outcomes & Findings for FACBC Prostate Therapy Response (NCT NCT02830880)
NCT ID: NCT02830880
Last Updated: 2020-01-07
Results Overview
Clinical response will be assessed with FACBC PET imaging. The same measurements of the lesions and background structures will be undertaken at baseline and post-therapy scan. The researchers utilized the following parameters to follow response to therapy: maximum standardized uptake value (SUVmax) of most intense lesion each of bone and node, sum and mean SUVmax of up to 5 index lesions for each of bone and node of most intense lesion each of bone and node of the 5 index lesions for each of bone and node. SUVmax measures uptake of the radiotracer by malignant cells. Percent change after therapy, compared to baseline, was calculated and a positive percent increase indicates greater uptake of FACBC by cancer cells.
COMPLETED
PHASE2
7 participants
Baseline, Cycle 1 (Week 2), Cycle 6 (Week 17)
2020-01-07
Participant Flow
Study participants were recruited from patients receiving services at Emory University Hospital in Atlanta, Georgia. Participant enrollment began in July 2016, follow up for the primary outcome measures was complete by December 1, 2018 and follow up for the secondary outcome measure was completed on September 30, 2019.
Participant milestones
| Measure |
FACBC PET-CT
Participants with biopsy-proven primary or recurrent castration-resistant prostate carcinoma with skeletal and/or nodal involvement receiving anti-1-amino-3-\[18F\]fluorocyclobutane-1-carboxylic acid (FACBC) radiotracer intravenously prior to positron emission tomography (PET) scan.
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|---|---|
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Overall Study
STARTED
|
7
|
|
Overall Study
Completed Visit After Cyle 1
|
7
|
|
Overall Study
COMPLETED
|
4
|
|
Overall Study
NOT COMPLETED
|
3
|
Reasons for withdrawal
| Measure |
FACBC PET-CT
Participants with biopsy-proven primary or recurrent castration-resistant prostate carcinoma with skeletal and/or nodal involvement receiving anti-1-amino-3-\[18F\]fluorocyclobutane-1-carboxylic acid (FACBC) radiotracer intravenously prior to positron emission tomography (PET) scan.
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|---|---|
|
Overall Study
Adverse reaction to chemotherapy
|
1
|
|
Overall Study
Death
|
1
|
|
Overall Study
Physician Decision
|
1
|
Baseline Characteristics
FACBC Prostate Therapy Response
Baseline characteristics by cohort
| Measure |
FACBC PET-CT
n=7 Participants
Participants with biopsy-proven primary or recurrent castration-resistant prostate carcinoma with skeletal and/or nodal involvement receiving Anti-3-\[18F\]FACBC radiotracer intravenously prior to PET scan.
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|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
1 Participants
n=93 Participants
|
|
Age, Categorical
>=65 years
|
6 Participants
n=93 Participants
|
|
Age, Continuous
|
79.0 years
STANDARD_DEVIATION 5.5 • n=93 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
7 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=93 Participants
|
|
Race (NIH/OMB)
White
|
6 Participants
n=93 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
|
Region of Enrollment
United States
|
7 Participants
n=93 Participants
|
PRIMARY outcome
Timeframe: Baseline, Cycle 1 (Week 2), Cycle 6 (Week 17)Population: This analysis includes participants completing the study visits used in each change from baseline determination.
Clinical response will be assessed with FACBC PET imaging. The same measurements of the lesions and background structures will be undertaken at baseline and post-therapy scan. The researchers utilized the following parameters to follow response to therapy: maximum standardized uptake value (SUVmax) of most intense lesion each of bone and node, sum and mean SUVmax of up to 5 index lesions for each of bone and node of most intense lesion each of bone and node of the 5 index lesions for each of bone and node. SUVmax measures uptake of the radiotracer by malignant cells. Percent change after therapy, compared to baseline, was calculated and a positive percent increase indicates greater uptake of FACBC by cancer cells.
Outcome measures
| Measure |
FACBC PET-CT
n=7 Participants
Participants with biopsy-proven primary or recurrent castration-resistant prostate carcinoma with skeletal and/or nodal involvement receiving Anti-3-\[18F\]FACBC radiotracer intravenously prior to PET scan.
|
|---|---|
|
Percent Change Assessed by FACBC PET Scan
Percent change between Baseline and Cycle 1
|
3.2 percent change of SUVmax
Standard Deviation 32.6
|
|
Percent Change Assessed by FACBC PET Scan
Percent change between Baseline and Cycle 6
|
23.5 percent change of SUVmax
Standard Deviation 21.4
|
PRIMARY outcome
Timeframe: Baseline, Cycle 1 (Week 2), Cycle 6 (Week 17)Population: This analysis includes participants completing the study visits.
Prostate Specific Antigen (PSA) serum biomarker will be used to assess response to treatment. PSA level will be collected via blood draw. While a formal cutpoint signifying prostate cancer is not generally used as PSA levels vary between men, in general, higher PSA levels indicate prostate cancer.
Outcome measures
| Measure |
FACBC PET-CT
n=7 Participants
Participants with biopsy-proven primary or recurrent castration-resistant prostate carcinoma with skeletal and/or nodal involvement receiving Anti-3-\[18F\]FACBC radiotracer intravenously prior to PET scan.
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|---|---|
|
Prostate Specific Antigen Level
Baseline
|
249.8 nanograms per milliliter (ng/mL)
Standard Deviation 471.9
|
|
Prostate Specific Antigen Level
After completing Cycle 1
|
245.3 nanograms per milliliter (ng/mL)
Standard Deviation 472.5
|
|
Prostate Specific Antigen Level
After completing Cycle 6
|
39.9 nanograms per milliliter (ng/mL)
Standard Deviation 23.7
|
PRIMARY outcome
Timeframe: Baseline, Cycle 1 (Week 2), Cycle 6 (Week 17)Population: Data were not collected for this outcome measure as all participants had a CT scan rather than an MRI to assess response to treatment.
Participants will have an MRI or a CT scan to assess response to treatment. Treatment response will be reported as follows: * Complete Response (CR) Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. * Complete Response Unknown (CRU) * Partial Response (PR) At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters. * Stable Disease (NR/SD) Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD. * Progressive Disease (PD) At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this may include the baseline sum). The sum must also demonstrate an absolute increase of at least 5 mm.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: After Cycle 6 (Week 17)Population: This analysis includes participants completing the study.
A CT will be used to assess response to treatment. Treatment response will be reported as follows: * Complete Response (CR) Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. * Partial Response (PR) At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters. * Stable Disease (NR/SD) Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD. * Progressive Disease (PD) At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this may include the baseline sum). The sum must also demonstrate an absolute increase of at least 5 mm.
Outcome measures
| Measure |
FACBC PET-CT
n=4 Participants
Participants with biopsy-proven primary or recurrent castration-resistant prostate carcinoma with skeletal and/or nodal involvement receiving Anti-3-\[18F\]FACBC radiotracer intravenously prior to PET scan.
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|---|---|
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Number of Participants Responding to Treatment Assessed by CT Scan
Complete Response
|
0 Participants
|
|
Number of Participants Responding to Treatment Assessed by CT Scan
Partial Response
|
0 Participants
|
|
Number of Participants Responding to Treatment Assessed by CT Scan
Stable Disease
|
4 Participants
|
|
Number of Participants Responding to Treatment Assessed by CT Scan
Progressive Disease
|
0 Participants
|
PRIMARY outcome
Timeframe: Baseline, After Cycle 6 (Week 17)Population: This analysis includes participants who completed the study.
Each patient underwent 99mTc MDP whole body bone scanning at baseline, and after the 6th cycle. Bone scans findings were interpreted based on recommendations from Prostate Cancer Clinical Trial Working Group 3 (PCCTWG3) using a specialized Bone Scan Assessment Tool. The change in disease response after cycle 6 compared to the baseline assessment is presented here.
Outcome measures
| Measure |
FACBC PET-CT
n=4 Participants
Participants with biopsy-proven primary or recurrent castration-resistant prostate carcinoma with skeletal and/or nodal involvement receiving Anti-3-\[18F\]FACBC radiotracer intravenously prior to PET scan.
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|---|---|
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Number of Participants With a Clinical Response Assessed by Bone Scan
Difference in disease response: None
|
0 Participants
|
|
Number of Participants With a Clinical Response Assessed by Bone Scan
Difference in disease response: Response
|
0 Participants
|
|
Number of Participants With a Clinical Response Assessed by Bone Scan
Difference in disease response: Stable
|
2 Participants
|
|
Number of Participants With a Clinical Response Assessed by Bone Scan
Difference in disease response: Progressive
|
2 Participants
|
SECONDARY outcome
Timeframe: End of Study (up to 1 year)The number of deaths that have occurred was assessed at the end of study.
Outcome measures
| Measure |
FACBC PET-CT
n=7 Participants
Participants with biopsy-proven primary or recurrent castration-resistant prostate carcinoma with skeletal and/or nodal involvement receiving Anti-3-\[18F\]FACBC radiotracer intravenously prior to PET scan.
|
|---|---|
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Number of Deaths
|
3 Participants
|
Adverse Events
FACBC PET-CT
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