Trial Outcomes & Findings for FACBC Outcomes for Post Prostatectomy (NCT NCT01666808)
NCT ID: NCT01666808
Last Updated: 2023-08-02
Results Overview
Definition of failure is: serum PSA value of 0.2ng/mL or more above the postradiotherapy nadir followed by another higher value, a continued rise in the serum PSA despite radiotherapy (RT), initiation of systemic therapy after completion of RT, or clinical progression.
COMPLETED
PHASE2/PHASE3
165 participants
3-Year post-intervention
2023-08-02
Participant Flow
Participant milestones
| Measure |
FACBC PET Scan
A trial group in which anti-3-\[18F\]FACBC PET-CT is used to guide radiotherapy decisions and radiotherapy treatment volumes.
FACBC: FACBC is given intravenously prior to PET scan
|
Conventional-Only Imaging
A control group whose treatment decisions will be made based on conventional imaging - bone scan and abdominopelvic CT and/or MR scan.
|
|---|---|---|
|
Overall Study
STARTED
|
83
|
82
|
|
Overall Study
COMPLETED
|
67
|
66
|
|
Overall Study
NOT COMPLETED
|
16
|
16
|
Reasons for withdrawal
| Measure |
FACBC PET Scan
A trial group in which anti-3-\[18F\]FACBC PET-CT is used to guide radiotherapy decisions and radiotherapy treatment volumes.
FACBC: FACBC is given intravenously prior to PET scan
|
Conventional-Only Imaging
A control group whose treatment decisions will be made based on conventional imaging - bone scan and abdominopelvic CT and/or MR scan.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
9
|
15
|
|
Overall Study
Withdrawal by Subject
|
3
|
1
|
|
Overall Study
No radiotherapy given, due to extrapelvic uptake on PET scan
|
4
|
0
|
Baseline Characteristics
FACBC Outcomes for Post Prostatectomy
Baseline characteristics by cohort
| Measure |
FACBC PET Scan
n=83 Participants
A trial group in which anti-3-\[18F\]FACBC PET-CT is used to guide radiotherapy decisions and radiotherapy treatment volumes.
FACBC: FACBC is given intravenously prior to PET scan
|
Conventional-Only Imaging
n=82 Participants
A control group whose treatment decisions will be made based on conventional imaging - bone scan and abdominopelvic CT and/or MR scan.
|
Total
n=165 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
61 years
n=5 Participants
|
61 years
n=7 Participants
|
61 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
83 Participants
n=5 Participants
|
82 Participants
n=7 Participants
|
165 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
30 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
59 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
52 Participants
n=5 Participants
|
52 Participants
n=7 Participants
|
104 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
83 participants
n=5 Participants
|
82 participants
n=7 Participants
|
165 participants
n=5 Participants
|
|
Gleason score ≥8
|
23 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
52 Participants
n=5 Participants
|
|
Ave PSA before radiotherapy
|
0.34 ng/mL
n=5 Participants
|
0.34 ng/mL
n=7 Participants
|
0.34 ng/mL
n=5 Participants
|
PRIMARY outcome
Timeframe: 3-Year post-interventionPopulation: This outcome evaluated the failure-free survival difference (among those who received radiotherapy) between the trial group (in which FACBC PET scan was used) versus the control group (in which conventional-only imaging was used). FACBC PET Group: 83 enrolled subjects minus 3 withdrawals minus 4 patients not receiving radiotherapy due to PET findings = 76 participants. Conventional Imaging Group: 82 enrolled minus 1 withdrawal = 81 participants.
Definition of failure is: serum PSA value of 0.2ng/mL or more above the postradiotherapy nadir followed by another higher value, a continued rise in the serum PSA despite radiotherapy (RT), initiation of systemic therapy after completion of RT, or clinical progression.
Outcome measures
| Measure |
FACBC PET Scan
n=76 Participants
A trial group in which anti-3-\[18F\]FACBC PET-CT is used to guide radiotherapy decisions and radiotherapy treatment volumes.
FACBC: FACBC is given intravenously prior to PET scan
|
Conventional-Only Imaging
n=81 Participants
A control group whose treatment decisions will be made based on conventional imaging - bone scan and abdominopelvic CT and/or MR scan.
|
|---|---|---|
|
Failure-free Survival
|
75.5 Percentage of participants
|
63.0 Percentage of participants
|
SECONDARY outcome
Timeframe: Average of 1 week post-interventionPopulation: This outcome evaluated number of decision changes regarding the overall use of radiotherapy in the FACBC PET scan group only.
Number of decision changes regarding radiotherapy versus no radiotherapy based on F-Fluciclovine PET/CT guidance. This outcome was assessed immediately after the consensus reading of the Fluciclovine PET/CT was completed by nuclear medicine, an average of 1 week post intervention.
Outcome measures
| Measure |
FACBC PET Scan
n=83 Participants
A trial group in which anti-3-\[18F\]FACBC PET-CT is used to guide radiotherapy decisions and radiotherapy treatment volumes.
FACBC: FACBC is given intravenously prior to PET scan
|
Conventional-Only Imaging
A control group whose treatment decisions will be made based on conventional imaging - bone scan and abdominopelvic CT and/or MR scan.
|
|---|---|---|
|
Decision Changes Regarding Radiotherapy Versus no Radiotherapy
|
4 Number of decision changes
|
—
|
SECONDARY outcome
Timeframe: Average of 1 week post-interventionPopulation: This outcome evaluated number of decision changes regarding changes from whole-pelvis to local fields and vice versa (local fields to whole pelvis) in the FACBC PET scan group only.
Number of decision changes regarding whole-pelvis versus local fields. This outcome was assessed immediately after the consensus reading of the Fluciclovine PET/CT was completed by nuclear medicine, an average of 1 week post intervention.
Outcome measures
| Measure |
FACBC PET Scan
n=83 Participants
A trial group in which anti-3-\[18F\]FACBC PET-CT is used to guide radiotherapy decisions and radiotherapy treatment volumes.
FACBC: FACBC is given intravenously prior to PET scan
|
Conventional-Only Imaging
A control group whose treatment decisions will be made based on conventional imaging - bone scan and abdominopelvic CT and/or MR scan.
|
|---|---|---|
|
Decision Changes Regarding Whole-pelvis Versus Local Fields
|
24 Number of decision changes
|
—
|
SECONDARY outcome
Timeframe: Average of 1 week post-interventionPopulation: This outcome evaluated number of all radiotherapy-related decision changes in the FACBC PET scan group only.
Total number of radiotherapy decision changes regarding radiotherapy vs no radiotherapy and regarding whole pelvis vs local fields. This outcome was assessed immediately after the consensus reading of the Fluciclovine PET/CT was completed by nuclear medicine, an average of 1 week post intervention.
Outcome measures
| Measure |
FACBC PET Scan
n=83 Participants
A trial group in which anti-3-\[18F\]FACBC PET-CT is used to guide radiotherapy decisions and radiotherapy treatment volumes.
FACBC: FACBC is given intravenously prior to PET scan
|
Conventional-Only Imaging
A control group whose treatment decisions will be made based on conventional imaging - bone scan and abdominopelvic CT and/or MR scan.
|
|---|---|---|
|
Total Number of Decision Changes
|
28 Number of decision changes
|
—
|
SECONDARY outcome
Timeframe: Average of 1 month post-interventionPopulation: Note that no participants were analyzed in the Conventional group Post-PET since they did not receive the PET intervention. FACBC PET Group: 83 enrolled subjects minus 3 withdrawals minus 4 patients not receiving radiotherapy due to PET findings = 76 participants. Conventional Imaging Group: 82 enrolled minus 1 withdrawal = 81 participants.
Absolute volume pre- vs post-PET. This outcome was assessed after radiotherapy treatment planning was completed by radiation oncology, an average of 1 month post-intervention.
Outcome measures
| Measure |
FACBC PET Scan
n=76 Participants
A trial group in which anti-3-\[18F\]FACBC PET-CT is used to guide radiotherapy decisions and radiotherapy treatment volumes.
FACBC: FACBC is given intravenously prior to PET scan
|
Conventional-Only Imaging
n=81 Participants
A control group whose treatment decisions will be made based on conventional imaging - bone scan and abdominopelvic CT and/or MR scan.
|
|---|---|---|
|
Prostate Bed Clinical Target Volume (CTV)
Pre-PET
|
134.14 mL
Standard Deviation 45.60
|
137.18 mL
Standard Deviation 51.36
|
|
Prostate Bed Clinical Target Volume (CTV)
Post-PET
|
135.61 mL
Standard Deviation 45.51
|
—
|
SECONDARY outcome
Timeframe: Average of 1 month post-interventionPopulation: Note that no participants were analyzed in the Conventional group Post-PET since they did not receive the PET intervention. FACBC PET Group: 83 enrolled subjects minus 3 withdrawals minus 4 patients not receiving radiotherapy due to PET findings = 76 participants. Conventional Imaging Group: 82 enrolled minus 1 withdrawal = 81 participants.
Absolute volume were measured pre- vs post-PET. This outcome was assessed after radiotherapy treatment planning was completed by radiation oncology, an average of 1 month post-intervention.
Outcome measures
| Measure |
FACBC PET Scan
n=76 Participants
A trial group in which anti-3-\[18F\]FACBC PET-CT is used to guide radiotherapy decisions and radiotherapy treatment volumes.
FACBC: FACBC is given intravenously prior to PET scan
|
Conventional-Only Imaging
n=81 Participants
A control group whose treatment decisions will be made based on conventional imaging - bone scan and abdominopelvic CT and/or MR scan.
|
|---|---|---|
|
Prostate Bed Planning Target Volume (PTV)
Pre-PET
|
324.50 mL
Standard Deviation 79.82
|
327.71 mL
Standard Deviation 88.61
|
|
Prostate Bed Planning Target Volume (PTV)
Post-PET
|
329.54 mL
Standard Deviation 81.34
|
—
|
SECONDARY outcome
Timeframe: Average of 1 month post-interventionPopulation: Note that no participants were analyzed in the Conventional group Post-PET since they did not receive the PET intervention. FACBC PET Group: 83 enrolled subjects minus 3 withdrawals minus 4 patients not receiving radiotherapy due to PET findings = 76 participants. Conventional Imaging Group: 82 enrolled minus 1 withdrawal = 81 participants.
Standard radiotherapy dosimetric endpoints used to evaluate target coverage. Planning target volume (PTV) at V100 and V110 refer to %volume of the structure receiving 100% and 110% of the prescription dose, respectively, pre and post positron emission tomography (PET). This outcome was assessed after radiotherapy treatment planning was completed by radiation oncology, an average of 1 month post-intervention.
Outcome measures
| Measure |
FACBC PET Scan
n=76 Participants
A trial group in which anti-3-\[18F\]FACBC PET-CT is used to guide radiotherapy decisions and radiotherapy treatment volumes.
FACBC: FACBC is given intravenously prior to PET scan
|
Conventional-Only Imaging
n=81 Participants
A control group whose treatment decisions will be made based on conventional imaging - bone scan and abdominopelvic CT and/or MR scan.
|
|---|---|---|
|
PTV Dosimetric Endpoints
PTV2/PTV, V100% pre PET
|
96.98 percentage of volume
Standard Deviation 1.56
|
96.36 percentage of volume
Standard Deviation 1.67
|
|
PTV Dosimetric Endpoints
PTV2/PTV, V100% post PET
|
96.62 percentage of volume
Standard Deviation 1.54
|
—
|
|
PTV Dosimetric Endpoints
PTV2/PTV, V110% pre PET
|
2.60 percentage of volume
Standard Deviation 7.81
|
0.42 percentage of volume
Standard Deviation 1.89
|
|
PTV Dosimetric Endpoints
PTV2/PTV, V110% post PET
|
1.09 percentage of volume
Standard Deviation 6.11
|
—
|
SECONDARY outcome
Timeframe: Average of 1 month post-interventionPopulation: Note that no participants were analyzed in the Conventional group Post-PET since they did not receive the PET intervention. FACBC PET Group: 83 enrolled subjects minus 3 withdrawals minus 4 patients not receiving radiotherapy due to PET findings = 76 participants. Conventional Imaging Group: 82 enrolled minus 1 withdrawal = 81 participants.
Standard radiotherapy dosimetric endpoints used to evaluate normal tissue doses, in this case, the rectum. V40 and V65 refer to the %volume of the structure receiving 40 Gy and 65 Gy, respectively, pre and post positron emission tomography (PET) volumes were compared. This outcome was assessed after radiotherapy treatment planning was completed by radiation oncology, an average of 1 month post-intervention.
Outcome measures
| Measure |
FACBC PET Scan
n=76 Participants
A trial group in which anti-3-\[18F\]FACBC PET-CT is used to guide radiotherapy decisions and radiotherapy treatment volumes.
FACBC: FACBC is given intravenously prior to PET scan
|
Conventional-Only Imaging
n=81 Participants
A control group whose treatment decisions will be made based on conventional imaging - bone scan and abdominopelvic CT and/or MR scan.
|
|---|---|---|
|
Rectum Dosimetric Endpoints
Rectum, V40 pre PET
|
45.01 percentage of volume
Standard Deviation 10
|
45.03 percentage of volume
Standard Deviation 10.89
|
|
Rectum Dosimetric Endpoints
Rectum, V40 post PET
|
45.07 percentage of volume
Standard Deviation 9.78
|
—
|
|
Rectum Dosimetric Endpoints
Rectum, V65 pre PET
|
18.35 percentage of volume
Standard Deviation 7.78
|
19.31 percentage of volume
Standard Deviation 7.82
|
|
Rectum Dosimetric Endpoints
Rectum, V65 post PET
|
18.48 percentage of volume
Standard Deviation 7.78
|
—
|
SECONDARY outcome
Timeframe: Average of 1 month post-interventionPopulation: Note that no participants were analyzed in the Conventional group Post-PET since they did not receive the PET intervention. FACBC PET Group: 83 enrolled subjects minus 3 withdrawals minus 4 patients not receiving radiotherapy due to PET findings = 76 participants. Conventional Imaging Group: 82 enrolled minus 1 withdrawal = 81 participants.
Standard radiotherapy dosimetric endpoints are used to evaluate normal tissue doses, in this case, the bladder. V40 and V65 refer to the %volume of the structure receiving 40 Gy and 65 Gy, respectively, pre and post positron emission tomography (PET) volumes were compared. This outcome was assessed after radiotherapy treatment planning was completed by radiation oncology, an average of 1 month post-intervention.
Outcome measures
| Measure |
FACBC PET Scan
n=76 Participants
A trial group in which anti-3-\[18F\]FACBC PET-CT is used to guide radiotherapy decisions and radiotherapy treatment volumes.
FACBC: FACBC is given intravenously prior to PET scan
|
Conventional-Only Imaging
n=81 Participants
A control group whose treatment decisions will be made based on conventional imaging - bone scan and abdominopelvic CT and/or MR scan.
|
|---|---|---|
|
Bladder Dosimetric Endpoints
Bladder, V40 pre-PET
|
68.92 percentage of volume
Standard Deviation 14.94
|
68.95 percentage of volume
Standard Deviation 18.04
|
|
Bladder Dosimetric Endpoints
Bladder, V40 post-PET
|
69.10 percentage of volume
Standard Deviation 14.70
|
—
|
|
Bladder Dosimetric Endpoints
Bladder, V65 pre-PET
|
49.68 percentage of volume
Standard Deviation 17.31
|
50.99 percentage of volume
Standard Deviation 19.35
|
|
Bladder Dosimetric Endpoints
Bladder, V65 post-PET
|
50.29 percentage of volume
Standard Deviation 19.92
|
—
|
SECONDARY outcome
Timeframe: 3-Year post-interventionPopulation: All patients in both the FACBC PET scan and the Conventional-imaging only groups.
Provider-reported maximum acute (\<90 days Post-Intervention) and late (≥90 days and up to 3-Years post-intervention) genitourinary toxicity based on CTCAE v4.0 criteria.
Outcome measures
| Measure |
FACBC PET Scan
n=83 Participants
A trial group in which anti-3-\[18F\]FACBC PET-CT is used to guide radiotherapy decisions and radiotherapy treatment volumes.
FACBC: FACBC is given intravenously prior to PET scan
|
Conventional-Only Imaging
n=82 Participants
A control group whose treatment decisions will be made based on conventional imaging - bone scan and abdominopelvic CT and/or MR scan.
|
|---|---|---|
|
Rate of ≥ Grade 2 GU (Genitourinary [Renal or Urinary]) Toxicity
Number of patients with Acute GU toxicity
|
18 Participants
|
21 Participants
|
|
Rate of ≥ Grade 2 GU (Genitourinary [Renal or Urinary]) Toxicity
Number of patients with Late GU toxicity
|
36 Participants
|
42 Participants
|
SECONDARY outcome
Timeframe: 3-Year post-interventionPopulation: All patients in both the FACBC PET scan and the Conventional-imaging only groups.
Provider-reported maximum acute (\<90 days Post-Intervention) and late (≥90 days and up to 3-Years post-intervention) gastrointestinal toxicity ≥ Grade 2 based on CTCAE v4.0 criteria.
Outcome measures
| Measure |
FACBC PET Scan
n=83 Participants
A trial group in which anti-3-\[18F\]FACBC PET-CT is used to guide radiotherapy decisions and radiotherapy treatment volumes.
FACBC: FACBC is given intravenously prior to PET scan
|
Conventional-Only Imaging
n=82 Participants
A control group whose treatment decisions will be made based on conventional imaging - bone scan and abdominopelvic CT and/or MR scan.
|
|---|---|---|
|
Rate of ≥ Grade 2 GI (Gastrointestinal) Toxicity
Number of patients with Acute GI toxicity
|
16 Participants
|
11 Participants
|
|
Rate of ≥ Grade 2 GI (Gastrointestinal) Toxicity
Number of patients with Late GI toxicity
|
6 Participants
|
10 Participants
|
SECONDARY outcome
Timeframe: 3-Year post-interventionPopulation: Radiotherapy-treated patients in both the FACBC PET scan and the Conventional-imaging only groups. FACBC PET Group: 83 enrolled subjects minus 3 withdrawals minus 4 patients not receiving radiotherapy due to PET findings = 76 participants. Conventional Imaging Group: 82 enrolled minus 1 withdrawal = 81 participants.
Patient-reported maximum genitourinary toxicity based on standard EPIC-CP questionnaire. EPIC GU domain score has a total score range 0-12. Higher score correlates with worse outcome. EPIC GU score includes the incontinence domain score and the irritative/obstructive.
Outcome measures
| Measure |
FACBC PET Scan
n=76 Participants
A trial group in which anti-3-\[18F\]FACBC PET-CT is used to guide radiotherapy decisions and radiotherapy treatment volumes.
FACBC: FACBC is given intravenously prior to PET scan
|
Conventional-Only Imaging
n=81 Participants
A control group whose treatment decisions will be made based on conventional imaging - bone scan and abdominopelvic CT and/or MR scan.
|
|---|---|---|
|
Expanded Prostate Cancer Index Composite for Clinical Practice (EPIC) GU (Genitourinary) Domain Score
EPIC GU-incontinence domain score
|
2.99 score on a scale
Standard Deviation 3.10
|
3.50 score on a scale
Standard Deviation 3.02
|
|
Expanded Prostate Cancer Index Composite for Clinical Practice (EPIC) GU (Genitourinary) Domain Score
EPIC GU - irritative/obstructive
|
1.80 score on a scale
Standard Deviation 2.02
|
2.66 score on a scale
Standard Deviation 2.70
|
SECONDARY outcome
Timeframe: 3-Year post-interventionPopulation: Radiotherapy-treated patients in both the FACBC PET scan and the Conventional-imaging only groups. FACBC PET Group: 83 enrolled subjects minus 3 withdrawals minus 4 patients not receiving radiotherapy due to PET findings = 76 participants. Conventional Imaging Group: 82 enrolled minus 1 withdrawal = 81 participants.
Patient-reported maximum gastrointestinal toxicity based on standard EPIC-CP questionnaire. Total score range 0-12. Higher score correlates with worse outcome.
Outcome measures
| Measure |
FACBC PET Scan
n=76 Participants
A trial group in which anti-3-\[18F\]FACBC PET-CT is used to guide radiotherapy decisions and radiotherapy treatment volumes.
FACBC: FACBC is given intravenously prior to PET scan
|
Conventional-Only Imaging
n=81 Participants
A control group whose treatment decisions will be made based on conventional imaging - bone scan and abdominopelvic CT and/or MR scan.
|
|---|---|---|
|
Expanded Prostate Cancer Index Composite (EPIC) GI (Gastrointestinal) Domain Score
|
1.20 score on a scale
Standard Deviation 1.99
|
1.41 score on a scale
Standard Deviation 2.21
|
SECONDARY outcome
Timeframe: 3-Year post-interventionPopulation: Radiotherapy-treated patients in both the FACBC PET scan and the Conventional-imaging only groups. FACBC PET Group: 83 enrolled subjects minus 3 withdrawals minus 4 patients not receiving radiotherapy due to PET findings = 76 participants. Conventional Imaging Group: 82 enrolled minus 1 withdrawal = 81 participants.
Patient-reported maximum sexual function toxicity based on standard EPIC-CP questionnaire. Total score range 0-12. Higher score correlates with worse outcome.
Outcome measures
| Measure |
FACBC PET Scan
n=76 Participants
A trial group in which anti-3-\[18F\]FACBC PET-CT is used to guide radiotherapy decisions and radiotherapy treatment volumes.
FACBC: FACBC is given intravenously prior to PET scan
|
Conventional-Only Imaging
n=81 Participants
A control group whose treatment decisions will be made based on conventional imaging - bone scan and abdominopelvic CT and/or MR scan.
|
|---|---|---|
|
Expanded Prostate Cancer Index Composite (EPIC) Sexual Domain Score
|
6.04 score on a scale
Standard Deviation 4.14
|
7.37 score on a scale
Standard Deviation 3.79
|
SECONDARY outcome
Timeframe: 3-Year post-interventionPopulation: Radiotherapy-treated patients in both the FACBC PET scan and the Conventional-imaging only groups. FACBC PET Group: 83 enrolled subjects minus 3 withdrawals minus 4 patients not receiving radiotherapy due to PET findings = 76 participants. Conventional Imaging Group: 82 enrolled minus 1 withdrawal = 81 participants.
Patient-reported maximum overall (genitourinary, gastrointestinal, and sexual function) toxicity based on standard EPIC-CP questionnaire. Total score range 0-60. Higher score correlates with worse outcome.
Outcome measures
| Measure |
FACBC PET Scan
n=76 Participants
A trial group in which anti-3-\[18F\]FACBC PET-CT is used to guide radiotherapy decisions and radiotherapy treatment volumes.
FACBC: FACBC is given intravenously prior to PET scan
|
Conventional-Only Imaging
n=81 Participants
A control group whose treatment decisions will be made based on conventional imaging - bone scan and abdominopelvic CT and/or MR scan.
|
|---|---|---|
|
Expanded Prostate Cancer Index Composite (EPIC) Total Score
|
13.90 score on a scale
Standard Deviation 9.98
|
17.02 score on a scale
Standard Deviation 9.78
|
Adverse Events
FACBC PET Scan
Conventional-Only Imaging
Serious adverse events
| Measure |
FACBC PET Scan
n=83 participants at risk
A trial group in which anti-3-\[18F\]FACBC PET-CT is used to guide radiotherapy decisions and radiotherapy treatment volumes.
FACBC: FACBC is given intravenously prior to PET scan
|
Conventional-Only Imaging
n=82 participants at risk
A control group whose treatment decisions will be made based on conventional imaging - bone scan and abdominopelvic CT and/or MR scan.
|
|---|---|---|
|
Renal and urinary disorders
Hematuria - Acute
|
0.00%
0/83 • Up to 3-years post-intervention
Severe Adverse Events (SAEs) were defined as any provider-reported grade 3 or higher Gastrointestinal \[GI\] or Genitourinary \[GU\] toxicity. Acute toxicity was measured \<90 days Post-Intervention and late toxicity was measured ≥90 days and up to 3-Years post-intervention. Adverse Events (AE's) were defined as any provider-reported (acute or late) grade 2 toxicity.
|
3.7%
3/82 • Number of events 3 • Up to 3-years post-intervention
Severe Adverse Events (SAEs) were defined as any provider-reported grade 3 or higher Gastrointestinal \[GI\] or Genitourinary \[GU\] toxicity. Acute toxicity was measured \<90 days Post-Intervention and late toxicity was measured ≥90 days and up to 3-Years post-intervention. Adverse Events (AE's) were defined as any provider-reported (acute or late) grade 2 toxicity.
|
|
Renal and urinary disorders
Hematuria - Late
|
6.0%
5/83 • Number of events 5 • Up to 3-years post-intervention
Severe Adverse Events (SAEs) were defined as any provider-reported grade 3 or higher Gastrointestinal \[GI\] or Genitourinary \[GU\] toxicity. Acute toxicity was measured \<90 days Post-Intervention and late toxicity was measured ≥90 days and up to 3-Years post-intervention. Adverse Events (AE's) were defined as any provider-reported (acute or late) grade 2 toxicity.
|
6.1%
5/82 • Number of events 5 • Up to 3-years post-intervention
Severe Adverse Events (SAEs) were defined as any provider-reported grade 3 or higher Gastrointestinal \[GI\] or Genitourinary \[GU\] toxicity. Acute toxicity was measured \<90 days Post-Intervention and late toxicity was measured ≥90 days and up to 3-Years post-intervention. Adverse Events (AE's) were defined as any provider-reported (acute or late) grade 2 toxicity.
|
Other adverse events
| Measure |
FACBC PET Scan
n=83 participants at risk
A trial group in which anti-3-\[18F\]FACBC PET-CT is used to guide radiotherapy decisions and radiotherapy treatment volumes.
FACBC: FACBC is given intravenously prior to PET scan
|
Conventional-Only Imaging
n=82 participants at risk
A control group whose treatment decisions will be made based on conventional imaging - bone scan and abdominopelvic CT and/or MR scan.
|
|---|---|---|
|
Gastrointestinal disorders
Diarrhea
|
26.5%
22/83 • Number of events 22 • Up to 3-years post-intervention
Severe Adverse Events (SAEs) were defined as any provider-reported grade 3 or higher Gastrointestinal \[GI\] or Genitourinary \[GU\] toxicity. Acute toxicity was measured \<90 days Post-Intervention and late toxicity was measured ≥90 days and up to 3-Years post-intervention. Adverse Events (AE's) were defined as any provider-reported (acute or late) grade 2 toxicity.
|
25.6%
21/82 • Number of events 21 • Up to 3-years post-intervention
Severe Adverse Events (SAEs) were defined as any provider-reported grade 3 or higher Gastrointestinal \[GI\] or Genitourinary \[GU\] toxicity. Acute toxicity was measured \<90 days Post-Intervention and late toxicity was measured ≥90 days and up to 3-Years post-intervention. Adverse Events (AE's) were defined as any provider-reported (acute or late) grade 2 toxicity.
|
|
Renal and urinary disorders
Urinary Frequency
|
59.0%
49/83 • Number of events 49 • Up to 3-years post-intervention
Severe Adverse Events (SAEs) were defined as any provider-reported grade 3 or higher Gastrointestinal \[GI\] or Genitourinary \[GU\] toxicity. Acute toxicity was measured \<90 days Post-Intervention and late toxicity was measured ≥90 days and up to 3-Years post-intervention. Adverse Events (AE's) were defined as any provider-reported (acute or late) grade 2 toxicity.
|
67.1%
55/82 • Number of events 55 • Up to 3-years post-intervention
Severe Adverse Events (SAEs) were defined as any provider-reported grade 3 or higher Gastrointestinal \[GI\] or Genitourinary \[GU\] toxicity. Acute toxicity was measured \<90 days Post-Intervention and late toxicity was measured ≥90 days and up to 3-Years post-intervention. Adverse Events (AE's) were defined as any provider-reported (acute or late) grade 2 toxicity.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place