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FACBC Outcomes for Post Prostatectomy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01666808
Recruitment Status : Completed
First Posted : August 16, 2012
Results First Posted : August 2, 2023
Last Update Posted : August 2, 2023
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Ashesh B Jani, Emory University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Prostate Cancer
Interventions Drug: FACBC
Radiation: Radiation therapy
Enrollment 165
Recruitment Details  
Pre-assignment Details  
Arm/Group Title FACBC PET Scan Conventional-Only Imaging
Hide Arm/Group Description

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

 A control group whose treatment decisions will be made based on conventional imaging - bone scan and abdominopelvic CT and/or MR scan.
Period Title: Overall Study
Started 83 82
Completed 67 66
Not Completed 16 16
Reason Not Completed
Lost to Follow-up             9             15
Withdrawal by Subject             3             1
No radiotherapy given, due to extrapelvic uptake on PET scan             4             0
Arm/Group Title FACBC PET Scan Conventional-Only Imaging Total
Hide Arm/Group Description

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

 A control group whose treatment decisions will be made based on conventional imaging - bone scan and abdominopelvic CT and/or MR scan. Total of all reporting groups
Overall Number of Baseline Participants 83 82 165
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 83 participants 82 participants 165 participants
61
(42 to 75)
61
(46 to 78)
61
(42 to 78)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 83 participants 82 participants 165 participants
Female
0
   0.0%
0
   0.0%
0
   0.0%
Male
83
 100.0%
82
 100.0%
165
 100.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 83 participants 82 participants 165 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
30
  36.1%
29
  35.4%
59
  35.8%
White
52
  62.7%
52
  63.4%
104
  63.0%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
1
   1.2%
1
   1.2%
2
   1.2%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 83 participants 82 participants 165 participants
83 82 165
Gleason score ≥8   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 83 participants 82 participants 165 participants
23
  27.7%
29
  35.4%
52
  31.5%
[1]
Measure Description: Pathological grade was measured on the prostatectomy specimen. Gleason Grading goes from 2 thru 10, with higher scores being worse prognostically. Gleason scores of 8 and higher are considered high-grade, so this measure was designed to see whether the percentage of high-grade patients was balanced.
Ave PSA before radiotherapy  
Median (Inter-Quartile Range)
Unit of measure:  ng/mL
Number Analyzed 83 participants 82 participants 165 participants
0.34
(0.19 to 1.08)
0.34
(0.13 to 0.95)
0.34
(0.17 to 1.05)
1.Primary Outcome
Title Failure-free Survival
Hide Description 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.
Time Frame 3-Year post-intervention
Hide Outcome Measure Data
Hide Analysis Population Description

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.
Arm/Group Title FACBC PET Scan Conventional-Only Imaging
Hide Arm/Group Description:

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
A control group whose treatment decisions will be made based on conventional imaging - bone scan and abdominopelvic CT and/or MR scan.
Overall Number of Participants Analyzed 76 81
Measure Type: Number
Unit of Measure: Percentage of participants
75.5 63.0
2.Secondary Outcome
Title Decision Changes Regarding Radiotherapy Versus no Radiotherapy
Hide Description 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.
Time Frame Average of 1 week post-intervention
Hide Outcome Measure Data
Hide Analysis Population Description
This outcome evaluated number of decision changes regarding the overall use of radiotherapy in the FACBC PET scan group only.
Arm/Group Title FACBC PET Scan Conventional-Only Imaging
Hide Arm/Group Description:

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
A control group whose treatment decisions will be made based on conventional imaging - bone scan and abdominopelvic CT and/or MR scan.
Overall Number of Participants Analyzed 83 0
Measure Type: Number
Unit of Measure: Number of decision changes
4
3.Secondary Outcome
Title Decision Changes Regarding Whole-pelvis Versus Local Fields
Hide Description 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.
Time Frame Average of 1 week post-intervention
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title FACBC PET Scan Conventional-Only Imaging
Hide Arm/Group Description:

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
A control group whose treatment decisions will be made based on conventional imaging - bone scan and abdominopelvic CT and/or MR scan.
Overall Number of Participants Analyzed 83 0
Measure Type: Number
Unit of Measure: Number of decision changes
24
4.Secondary Outcome
Title Total Number of Decision Changes
Hide Description 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.
Time Frame Average of 1 week post-intervention
Hide Outcome Measure Data
Hide Analysis Population Description
This outcome evaluated number of all radiotherapy-related decision changes in the FACBC PET scan group only.
Arm/Group Title FACBC PET Scan Conventional-Only Imaging
Hide Arm/Group Description:

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
A control group whose treatment decisions will be made based on conventional imaging - bone scan and abdominopelvic CT and/or MR scan.
Overall Number of Participants Analyzed 83 0
Measure Type: Number
Unit of Measure: Number of decision changes
28
5.Secondary Outcome
Title Prostate Bed Clinical Target Volume (CTV)
Hide Description 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.
Time Frame Average of 1 month post-intervention
Hide Outcome Measure Data
Hide Analysis Population Description

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.
Arm/Group Title FACBC PET Scan Conventional-Only Imaging
Hide Arm/Group Description:

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
A control group whose treatment decisions will be made based on conventional imaging - bone scan and abdominopelvic CT and/or MR scan.
Overall Number of Participants Analyzed 76 81
Mean (Standard Deviation)
Unit of Measure: mL
Pre-PET Number Analyzed 76 participants 81 participants
134.14  (45.60) 137.18  (51.36)
Post-PET Number Analyzed 76 participants 0 participants
135.61  (45.51)
6.Secondary Outcome
Title Prostate Bed Planning Target Volume (PTV)
Hide Description 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.
Time Frame Average of 1 month post-intervention
Hide Outcome Measure Data
Hide Analysis Population Description

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.
Arm/Group Title FACBC PET Scan Conventional-Only Imaging
Hide Arm/Group Description:

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
A control group whose treatment decisions will be made based on conventional imaging - bone scan and abdominopelvic CT and/or MR scan.
Overall Number of Participants Analyzed 76 81
Mean (Standard Deviation)
Unit of Measure: mL
Pre-PET Number Analyzed 76 participants 81 participants
324.50  (79.82) 327.71  (88.61)
Post-PET Number Analyzed 76 participants 0 participants
329.54  (81.34)
7.Secondary Outcome
Title PTV Dosimetric Endpoints
Hide Description 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.
Time Frame Average of 1 month post-intervention
Hide Outcome Measure Data
Hide Analysis Population Description

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.
Arm/Group Title FACBC PET Scan Conventional-Only Imaging
Hide Arm/Group Description:

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
A control group whose treatment decisions will be made based on conventional imaging - bone scan and abdominopelvic CT and/or MR scan.
Overall Number of Participants Analyzed 76 81
Mean (Standard Deviation)
Unit of Measure: percentage of volume
PTV2/PTV, V100% pre PET Number Analyzed 76 participants 81 participants
96.98  (1.56) 96.36  (1.67)
PTV2/PTV, V100% post PET Number Analyzed 76 participants 0 participants
96.62  (1.54)
PTV2/PTV, V110% pre PET Number Analyzed 76 participants 81 participants
2.60  (7.81) 0.42  (1.89)
PTV2/PTV, V110% post PET Number Analyzed 76 participants 0 participants
1.09  (6.11)
8.Secondary Outcome
Title Rectum Dosimetric Endpoints
Hide Description 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.
Time Frame Average of 1 month post-intervention
Hide Outcome Measure Data
Hide Analysis Population Description

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.
Arm/Group Title FACBC PET Scan Conventional-Only Imaging
Hide Arm/Group Description:

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
A control group whose treatment decisions will be made based on conventional imaging - bone scan and abdominopelvic CT and/or MR scan.
Overall Number of Participants Analyzed 76 81
Mean (Standard Deviation)
Unit of Measure: percentage of volume
Rectum, V40 pre PET Number Analyzed 76 participants 81 participants
45.01  (10) 45.03  (10.89)
Rectum, V40 post PET Number Analyzed 76 participants 0 participants
45.07  (9.78)
Rectum, V65 pre PET Number Analyzed 76 participants 81 participants
18.35  (7.78) 19.31  (7.82)
Rectum, V65 post PET Number Analyzed 76 participants 0 participants
18.48  (7.78)
9.Secondary Outcome
Title Bladder Dosimetric Endpoints
Hide Description 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.
Time Frame Average of 1 month post-intervention
Hide Outcome Measure Data
Hide Analysis Population Description

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.
Arm/Group Title FACBC PET Scan Conventional-Only Imaging
Hide Arm/Group Description:

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
A control group whose treatment decisions will be made based on conventional imaging - bone scan and abdominopelvic CT and/or MR scan.
Overall Number of Participants Analyzed 76 81
Mean (Standard Deviation)
Unit of Measure: percentage of volume
Bladder, V40 pre-PET Number Analyzed 76 participants 81 participants
68.92  (14.94) 68.95  (18.04)
Bladder, V40 post-PET Number Analyzed 76 participants 0 participants
69.10  (14.70)
Bladder, V65 pre-PET Number Analyzed 76 participants 81 participants
49.68  (17.31) 50.99  (19.35)
Bladder, V65 post-PET Number Analyzed 76 participants 0 participants
50.29  (19.92)
10.Secondary Outcome
Title Rate of ≥ Grade 2 GU (Genitourinary [Renal or Urinary]) Toxicity
Hide Description 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.
Time Frame 3-Year post-intervention
Hide Outcome Measure Data
Hide Analysis Population Description
All patients in both the FACBC PET scan and the Conventional-imaging only groups.
Arm/Group Title FACBC PET Scan Conventional-Only Imaging
Hide Arm/Group Description:

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
A control group whose treatment decisions will be made based on conventional imaging - bone scan and abdominopelvic CT and/or MR scan.
Overall Number of Participants Analyzed 83 82
Measure Type: Count of Participants
Unit of Measure: Participants
Number of patients with Acute GU toxicity
18
  21.7%
21
  25.6%
Number of patients with Late GU toxicity
36
  43.4%
42
  51.2%
11.Secondary Outcome
Title Rate of ≥ Grade 2 GI (Gastrointestinal) Toxicity
Hide Description 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.
Time Frame 3-Year post-intervention
Hide Outcome Measure Data
Hide Analysis Population Description
All patients in both the FACBC PET scan and the Conventional-imaging only groups.
Arm/Group Title FACBC PET Scan Conventional-Only Imaging
Hide Arm/Group Description:

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
A control group whose treatment decisions will be made based on conventional imaging - bone scan and abdominopelvic CT and/or MR scan.
Overall Number of Participants Analyzed 83 82
Measure Type: Count of Participants
Unit of Measure: Participants
Number of patients with Acute GI toxicity
16
  19.3%
11
  13.4%
Number of patients with Late GI toxicity
6
   7.2%
10
  12.2%
12.Secondary Outcome
Title Expanded Prostate Cancer Index Composite for Clinical Practice (EPIC) GU (Genitourinary) Domain Score
Hide Description 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.
Time Frame 3-Year post-intervention
Hide Outcome Measure Data
Hide Analysis Population Description

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.
Arm/Group Title FACBC PET Scan Conventional-Only Imaging
Hide Arm/Group Description:

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
A control group whose treatment decisions will be made based on conventional imaging - bone scan and abdominopelvic CT and/or MR scan.
Overall Number of Participants Analyzed 76 81
Mean (Standard Deviation)
Unit of Measure: score on a scale
EPIC GU-incontinence domain score 2.99  (3.10) 3.50  (3.02)
EPIC GU - irritative/obstructive 1.80  (2.02) 2.66  (2.70)
13.Secondary Outcome
Title Expanded Prostate Cancer Index Composite (EPIC) GI (Gastrointestinal) Domain Score
Hide Description Patient-reported maximum gastrointestinal toxicity based on standard EPIC-CP questionnaire. Total score range 0-12. Higher score correlates with worse outcome.
Time Frame 3-Year post-intervention
Hide Outcome Measure Data
Hide Analysis Population Description

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.
Arm/Group Title FACBC PET Scan Conventional-Only Imaging
Hide Arm/Group Description:

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
A control group whose treatment decisions will be made based on conventional imaging - bone scan and abdominopelvic CT and/or MR scan.
Overall Number of Participants Analyzed 76 81
Mean (Standard Deviation)
Unit of Measure: score on a scale
1.20  (1.99) 1.41  (2.21)
14.Secondary Outcome
Title Expanded Prostate Cancer Index Composite (EPIC) Sexual Domain Score
Hide Description Patient-reported maximum sexual function toxicity based on standard EPIC-CP questionnaire. Total score range 0-12. Higher score correlates with worse outcome.
Time Frame 3-Year post-intervention
Hide Outcome Measure Data
Hide Analysis Population Description

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.
Arm/Group Title FACBC PET Scan Conventional-Only Imaging
Hide Arm/Group Description:

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
A control group whose treatment decisions will be made based on conventional imaging - bone scan and abdominopelvic CT and/or MR scan.
Overall Number of Participants Analyzed 76 81
Mean (Standard Deviation)
Unit of Measure: score on a scale
6.04  (4.14) 7.37  (3.79)
15.Secondary Outcome
Title Expanded Prostate Cancer Index Composite (EPIC) Total Score
Hide Description 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.
Time Frame 3-Year post-intervention
Hide Outcome Measure Data
Hide Analysis Population Description

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.
Arm/Group Title FACBC PET Scan Conventional-Only Imaging
Hide Arm/Group Description:

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
A control group whose treatment decisions will be made based on conventional imaging - bone scan and abdominopelvic CT and/or MR scan.
Overall Number of Participants Analyzed 76 81
Mean (Standard Deviation)
Unit of Measure: score on a scale
13.90  (9.98) 17.02  (9.78)
Time Frame Up to 3-years post-intervention
Adverse Event Reporting Description

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.
 
Arm/Group Title FACBC PET Scan Conventional-Only Imaging
Hide Arm/Group Description

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

 A control group whose treatment decisions will be made based on conventional imaging - bone scan and abdominopelvic CT and/or MR scan.
All-Cause Mortality
FACBC PET Scan Conventional-Only Imaging
Affected / at Risk (%) Affected / at Risk (%)
Total   1/83 (1.20%)      1/82 (1.22%)    
Hide Serious Adverse Events
FACBC PET Scan Conventional-Only Imaging
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   5/83 (6.02%)      8/82 (9.76%)    
Renal and urinary disorders     
Hematuria - Acute †  0/83 (0.00%)  0 3/82 (3.66%)  3
Hematuria - Late †  5/83 (6.02%)  5 5/82 (6.10%)  5
†
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
FACBC PET Scan Conventional-Only Imaging
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   71/83 (85.54%)      76/82 (92.68%)    
Gastrointestinal disorders     
Diarrhea †  22/83 (26.51%)  22 21/82 (25.61%)  21
Renal and urinary disorders     
Urinary Frequency †  49/83 (59.04%)  49 55/82 (67.07%)  55
†
Indicates events were collected by systematic assessment
[Not Specified]
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Ashesh Jani
Organization: Emory University
Phone: 404-778-3827
EMail: abjani@emory.edu
Publications of Results:
Jani AB, Schreibmann E, Goyal S, Halkar R, Hershatter B, Rossi PJ, Shelton JW, Patel PR, Xu KM, Goodman M, Master VA, Joshi SS, Kucuk O, Carthon BC, Bilen MA, Abiodun-Ojo OA, Akintayo AA, Dhere VR, Schuster DM. 18F-fluciclovine-PET/CT imaging versus conventional imaging alone to guide postprostatectomy salvage radiotherapy for prostate cancer (EMPIRE-1): a single centre, open-label, phase 2/3 randomised controlled trial. Lancet. 2021 May 22;397(10288):1895-1904. doi: 10.1016/S0140-6736(21)00581-X. Epub 2021 May 7.
Dhere VR, Schuster DM, Goyal S, Schreibmann E, Hershatter BW, Rossi PJ, Shelton JW, Patel PR, Jani AB. Randomized Trial of Conventional Versus Conventional Plus Fluciclovine (18F) Positron Emission Tomography/Computed Tomography-Guided Postprostatectomy Radiation Therapy for Prostate Cancer: Volumetric and Patient-Reported Analyses of Toxic Effects. Int J Radiat Oncol Biol Phys. 2022 Aug 1;113(5):1003-1014. doi: 10.1016/j.ijrobp.2022.04.005. Epub 2022 Apr 11.
Layout table for additonal information
Responsible Party: Ashesh B Jani, Emory University
ClinicalTrials.gov Identifier: NCT01666808    
Other Study ID Numbers: IRB00057680
1R01CA169188-01 ( U.S. NIH Grant/Contract )
First Submitted: August 14, 2012
First Posted: August 16, 2012
Results First Submitted: April 12, 2023
Results First Posted: August 2, 2023
Last Update Posted: August 2, 2023