Prostate Cancer
Conditions
Brief summary
Investigators will perform a study with 162 patients in whom there is a strong suspicion of prostate cancer that has returned to the body after having a prostatectomy. Half of these patients will have radiotherapy decision-making and delivery per the usual routine, and half of these patients will have the radiotherapy decision and volumes guided by the FACBC test (anti-1-amino-3-\[18F\]fluorocyclobutane-1-carboxylic acid (anti-3- \[18F\]FACBC). The major goal of the investigation is to see whether the FACBC improves the selection and the cancer control rates of post-surgery patients with a rising PSA who undergo radiotherapy.
Detailed description
Prostate cancer is the most common solid tumor, with approximately 200,000 new cases diagnosed per year. Several different local therapies are available for treatment, including surgery and radiotherapy Significant advances have been made in the technical aspects of surgery and of radiotherapy which have improved both the cancer control outcomes as well as the morbidity of treatment. Despite these significant advances, approximately 30% of patients treated with definitive local therapy experience recurrent disease. Recurrent disease after prostatectomy usually manifests with rising PSA (blood test for prostate cancer). The PSA level is often of limited use in differentiating local recurrence (ie. recurrence in the prostate bed) from recurrence outside of the prostate bed ( extra-prostatic recurrence). One PET radiotracer which has shown promise in the staging and restaging of patients with prostate carcinoma is anti-1-amino-3-\[18F\]fluorocyclobutane-1-carboxylic acid (anti-3-\[18F\]FACBC) which is a synthetic amino acid analog. FACBC demonstrated higher accuracy compared with 111Indium-capromab-pendetide in the restaging of patients with suspected recurrent prostate carcinoma. The major goal in this proposed investigation is to use advanced molecular imaging to better guide post-prostatectomy decision making, in terms of guiding the decision to deliver radiotherapy, and in terms of the exact areas treated with radiotherapy. Investigators will perform a study with 162 patients in whom there is a strong suspicion of prostate cancer that has returned to the body after having a prostatectomy. Half of these patients will have radiotherapy decision-making and delivery per the usual routine, and half of these patients will have the radiotherapy decision and volumes guided by the FACBC test. The major goal of the investigation is to see whether the FACBC improves the selection and the cancer control rates of post-surgery patients with a rising PSA who undergo radiotherapy.
Interventions
DRUGFACBC
FACBC is given intravenously prior to PET scan, radiotherapy decisions and treatment guided by PET findings
RADIATIONRadiation therapy
External beam radiotherapy to prostate bed +/- pelvic lymph nodes; final dose of 66.6 Gy.
Sponsors
National Cancer Institute (NCI)
Emory University
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 95 Years
Healthy volunteers
No
Inclusion criteria
* Adenocarcinoma of the prostate, post radical-prostatectomy Detectable PSA * ECOG/Zubrod Performance Status of 0-2 * Negative technetium 99-m MDP or F-18 PET bone scan for skeletal metastasis * CT or MR scan of abdomen and pelvis which does not suggest presence of metastatic disease outside of the pelvis * Willingness to undergo pelvic radiotherapy.
Exclusion criteria
* Contraindications to radiotherapy (including active inflammatory bowel disease or prior pelvic XRT) * Inability to undergo anti-3-\[18F\]FACBC PET-CT * Age under 18 * Metastatic disease outside of pelvis on any imaging or biopsy * Prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of 3 years * Severe acute co-morbidity, defined as follows: * Unstable angina and/or congestive heart failure requiring hospitalization in the last 3 months * Transmural myocardial infarction within the last 6 months * Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration * Chronic Obstructive Pulmonary Disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at the time of registration * Acquired Immune Deficiency Syndrome (AIDS) based upon current CDC definition; note, however, that HIV testing is not required for entry into this protocol. The need to exclude patients with AIDS from this protocol is necessary because the treatments involved in this protocol may be significantly immunosuppressive. Protocol-specific requirements may also exclude immunocompromised patients
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Failure-free Survival | 3-Year post-intervention | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Decision Changes Regarding Whole-pelvis Versus Local Fields | Average of 1 week post-intervention | 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. |
| Total Number of Decision Changes | Average of 1 week post-intervention | 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. |
| Prostate Bed Clinical Target Volume (CTV) | Average of 1 month post-intervention | 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. |
| Prostate Bed Planning Target Volume (PTV) | Average of 1 month post-intervention | 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. |
| PTV Dosimetric Endpoints | Average of 1 month post-intervention | 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. |
| Rectum Dosimetric Endpoints | Average of 1 month post-intervention | 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. |
| Decision Changes Regarding Radiotherapy Versus no Radiotherapy | Average of 1 week post-intervention | 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. |
| Rate of ≥ Grade 2 GU (Genitourinary [Renal or Urinary]) Toxicity | 3-Year post-intervention | 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. |
| Rate of ≥ Grade 2 GI (Gastrointestinal) Toxicity | 3-Year post-intervention | 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. |
| Expanded Prostate Cancer Index Composite for Clinical Practice (EPIC) GU (Genitourinary) Domain Score | 3-Year post-intervention | 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. |
| Expanded Prostate Cancer Index Composite (EPIC) GI (Gastrointestinal) Domain Score | 3-Year post-intervention | Patient-reported maximum gastrointestinal toxicity based on standard EPIC-CP questionnaire. Total score range 0-12. Higher score correlates with worse outcome. |
| Expanded Prostate Cancer Index Composite (EPIC) Sexual Domain Score | 3-Year post-intervention | Patient-reported maximum sexual function toxicity based on standard EPIC-CP questionnaire. Total score range 0-12. Higher score correlates with worse outcome. |
| Expanded Prostate Cancer Index Composite (EPIC) Total Score | 3-Year post-intervention | 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. |
| Bladder Dosimetric Endpoints | Average of 1 month post-intervention | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 83 |
| 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. | 82 |
| Total | 165 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 9 | 15 |
| Overall Study | No radiotherapy given, due to extrapelvic uptake on PET scan | 4 | 0 |
| Overall Study | Withdrawal by Subject | 3 | 1 |
Baseline characteristics
| Characteristic | FACBC PET Scan | Conventional-Only Imaging | Total |
|---|---|---|---|
| Age, Continuous | 61 years | 61 years | 61 years |
| Ave PSA before radiotherapy | 0.34 ng/mL | 0.34 ng/mL | 0.34 ng/mL |
| Gleason score ≥8 | 23 Participants | 29 Participants | 52 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 30 Participants | 29 Participants | 59 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) White | 52 Participants | 52 Participants | 104 Participants |
| Region of Enrollment United States | 83 participants | 82 participants | 165 participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 83 Participants | 82 Participants | 165 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 1 / 83 | 1 / 82 |
| other Total, other adverse events | 71 / 83 | 76 / 82 |
| serious Total, serious adverse events | 5 / 83 | 8 / 82 |
Outcome results
Primary
Failure-free Survival
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
Population: 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 | Measure | Value (NUMBER) |
|---|---|---|
| FACBC PET Scan | Failure-free Survival | 75.5 Percentage of participants |
| Conventional-Only Imaging | Failure-free Survival | 63.0 Percentage of participants |
Secondary
Bladder Dosimetric Endpoints
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
Population: 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 | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| FACBC PET Scan | Bladder Dosimetric Endpoints | Bladder, V40 pre-PET | 68.92 percentage of volume | Standard Deviation 14.94 |
| FACBC PET Scan | Bladder Dosimetric Endpoints | Bladder, V40 post-PET | 69.10 percentage of volume | Standard Deviation 14.7 |
| FACBC PET Scan | Bladder Dosimetric Endpoints | Bladder, V65 pre-PET | 49.68 percentage of volume | Standard Deviation 17.31 |
| FACBC PET Scan | Bladder Dosimetric Endpoints | Bladder, V65 post-PET | 50.29 percentage of volume | Standard Deviation 19.92 |
| Conventional-Only Imaging | Bladder Dosimetric Endpoints | Bladder, V40 pre-PET | 68.95 percentage of volume | Standard Deviation 18.04 |
| Conventional-Only Imaging | Bladder Dosimetric Endpoints | Bladder, V65 pre-PET | 50.99 percentage of volume | Standard Deviation 19.35 |
Secondary
Decision Changes Regarding Radiotherapy Versus no Radiotherapy
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
Population: This outcome evaluated number of decision changes regarding the overall use of radiotherapy in the FACBC PET scan group only.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| FACBC PET Scan | Decision Changes Regarding Radiotherapy Versus no Radiotherapy | 4 Number of decision changes |
Secondary
Decision Changes Regarding Whole-pelvis Versus Local Fields
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
Population: 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 | Measure | Value (NUMBER) |
|---|---|---|
| FACBC PET Scan | Decision Changes Regarding Whole-pelvis Versus Local Fields | 24 Number of decision changes |
Secondary
Expanded Prostate Cancer Index Composite (EPIC) GI (Gastrointestinal) Domain Score
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
Population: 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 | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| FACBC PET Scan | Expanded Prostate Cancer Index Composite (EPIC) GI (Gastrointestinal) Domain Score | 1.20 score on a scale | Standard Deviation 1.99 |
| Conventional-Only Imaging | Expanded Prostate Cancer Index Composite (EPIC) GI (Gastrointestinal) Domain Score | 1.41 score on a scale | Standard Deviation 2.21 |
Secondary
Expanded Prostate Cancer Index Composite (EPIC) Sexual Domain Score
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
Population: 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 | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| FACBC PET Scan | Expanded Prostate Cancer Index Composite (EPIC) Sexual Domain Score | 6.04 score on a scale | Standard Deviation 4.14 |
| Conventional-Only Imaging | Expanded Prostate Cancer Index Composite (EPIC) Sexual Domain Score | 7.37 score on a scale | Standard Deviation 3.79 |
Secondary
Expanded Prostate Cancer Index Composite (EPIC) Total Score
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
Population: 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 | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| FACBC PET Scan | Expanded Prostate Cancer Index Composite (EPIC) Total Score | 13.90 score on a scale | Standard Deviation 9.98 |
| Conventional-Only Imaging | Expanded Prostate Cancer Index Composite (EPIC) Total Score | 17.02 score on a scale | Standard Deviation 9.78 |
Secondary
Expanded Prostate Cancer Index Composite for Clinical Practice (EPIC) GU (Genitourinary) Domain Score
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
Population: 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 | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| FACBC PET 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 3.1 |
| FACBC PET Scan | 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 |
| Conventional-Only Imaging | Expanded Prostate Cancer Index Composite for Clinical Practice (EPIC) GU (Genitourinary) Domain Score | EPIC GU-incontinence domain score | 3.50 score on a scale | Standard Deviation 3.02 |
| Conventional-Only Imaging | Expanded Prostate Cancer Index Composite for Clinical Practice (EPIC) GU (Genitourinary) Domain Score | EPIC GU - irritative/obstructive | 2.66 score on a scale | Standard Deviation 2.7 |
Secondary
Prostate Bed Clinical Target Volume (CTV)
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
Population: 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 | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| FACBC PET Scan | Prostate Bed Clinical Target Volume (CTV) | Pre-PET | 134.14 mL | Standard Deviation 45.6 |
| FACBC PET Scan | Prostate Bed Clinical Target Volume (CTV) | Post-PET | 135.61 mL | Standard Deviation 45.51 |
| Conventional-Only Imaging | Prostate Bed Clinical Target Volume (CTV) | Pre-PET | 137.18 mL | Standard Deviation 51.36 |
Secondary
Prostate Bed Planning Target Volume (PTV)
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
Population: 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 | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| FACBC PET Scan | Prostate Bed Planning Target Volume (PTV) | Pre-PET | 324.50 mL | Standard Deviation 79.82 |
| FACBC PET Scan | Prostate Bed Planning Target Volume (PTV) | Post-PET | 329.54 mL | Standard Deviation 81.34 |
| Conventional-Only Imaging | Prostate Bed Planning Target Volume (PTV) | Pre-PET | 327.71 mL | Standard Deviation 88.61 |
Secondary
PTV Dosimetric Endpoints
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
Population: 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 | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| FACBC PET Scan | PTV Dosimetric Endpoints | PTV2/PTV, V100% pre PET | 96.98 percentage of volume | Standard Deviation 1.56 |
| FACBC PET Scan | PTV Dosimetric Endpoints | PTV2/PTV, V100% post PET | 96.62 percentage of volume | Standard Deviation 1.54 |
| FACBC PET Scan | PTV Dosimetric Endpoints | PTV2/PTV, V110% pre PET | 2.60 percentage of volume | Standard Deviation 7.81 |
| FACBC PET Scan | PTV Dosimetric Endpoints | PTV2/PTV, V110% post PET | 1.09 percentage of volume | Standard Deviation 6.11 |
| Conventional-Only Imaging | PTV Dosimetric Endpoints | PTV2/PTV, V100% pre PET | 96.36 percentage of volume | Standard Deviation 1.67 |
| Conventional-Only Imaging | PTV Dosimetric Endpoints | PTV2/PTV, V110% pre PET | 0.42 percentage of volume | Standard Deviation 1.89 |
Secondary
Rate of ≥ Grade 2 GI (Gastrointestinal) Toxicity
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
Population: All patients in both the FACBC PET scan and the Conventional-imaging only groups.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| FACBC PET Scan | Rate of ≥ Grade 2 GI (Gastrointestinal) Toxicity | Number of patients with Acute GI toxicity | 16 Participants |
| FACBC PET Scan | Rate of ≥ Grade 2 GI (Gastrointestinal) Toxicity | Number of patients with Late GI toxicity | 6 Participants |
| Conventional-Only Imaging | Rate of ≥ Grade 2 GI (Gastrointestinal) Toxicity | Number of patients with Acute GI toxicity | 11 Participants |
| Conventional-Only Imaging | Rate of ≥ Grade 2 GI (Gastrointestinal) Toxicity | Number of patients with Late GI toxicity | 10 Participants |
Secondary
Rate of ≥ Grade 2 GU (Genitourinary [Renal or Urinary]) Toxicity
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
Population: All patients in both the FACBC PET scan and the Conventional-imaging only groups.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| FACBC PET Scan | Rate of ≥ Grade 2 GU (Genitourinary [Renal or Urinary]) Toxicity | Number of patients with Acute GU toxicity | 18 Participants |
| FACBC PET Scan | Rate of ≥ Grade 2 GU (Genitourinary [Renal or Urinary]) Toxicity | Number of patients with Late GU toxicity | 36 Participants |
| Conventional-Only Imaging | Rate of ≥ Grade 2 GU (Genitourinary [Renal or Urinary]) Toxicity | Number of patients with Acute GU toxicity | 21 Participants |
| Conventional-Only Imaging | Rate of ≥ Grade 2 GU (Genitourinary [Renal or Urinary]) Toxicity | Number of patients with Late GU toxicity | 42 Participants |
Secondary
Rectum Dosimetric Endpoints
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
Population: 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 | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| FACBC PET Scan | Rectum Dosimetric Endpoints | Rectum, V40 pre PET | 45.01 percentage of volume | Standard Deviation 10 |
| FACBC PET Scan | Rectum Dosimetric Endpoints | Rectum, V40 post PET | 45.07 percentage of volume | Standard Deviation 9.78 |
| FACBC PET Scan | Rectum Dosimetric Endpoints | Rectum, V65 pre PET | 18.35 percentage of volume | Standard Deviation 7.78 |
| FACBC PET Scan | Rectum Dosimetric Endpoints | Rectum, V65 post PET | 18.48 percentage of volume | Standard Deviation 7.78 |
| Conventional-Only Imaging | Rectum Dosimetric Endpoints | Rectum, V40 pre PET | 45.03 percentage of volume | Standard Deviation 10.89 |
| Conventional-Only Imaging | Rectum Dosimetric Endpoints | Rectum, V65 pre PET | 19.31 percentage of volume | Standard Deviation 7.82 |
Secondary
Total Number of Decision Changes
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
Population: This outcome evaluated number of all radiotherapy-related decision changes in the FACBC PET scan group only.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| FACBC PET Scan | Total Number of Decision Changes | 28 Number of decision changes |