Metastatic Prostate Carcinoma, Stage IVB Prostate Cancer AJCC v8
Conditions
Brief summary
This phase IV trial studies how well an investigational scan (18F-fluciclovine PET-CT) works for the measurement of therapeutic response in patients with prostate cancer that has spread to other places in the body (metastatic). 18F-fluciclovine is a radioactive substance that is used in this study with PET-CT imaging scans that may help doctors learn about response to standard therapy in patients with prostate cancer.
Detailed description
PRIMARY OBJECTIVE: I. Evaluate metabolic response by fluciclovine F18 (18F-fluciclovine) PET qualitatively and semi-quantitatively with standardized uptake values (SUV) following androgen deprivation therapy (ADT) plus abiraterone at 22-28 weeks (+/- 4 weeks), and correlate the findings with size changes as defined by conventional imaging and prostate-specific antigen (PSA) response. SECONDARY OBJECTIVES: I. To correlate pelvic 18F-fluciclovine PET imaging findings with pathologic findings at radical prostatectomy and pelvic lymph node dissection to determine 18F-fluciclovine PET imaging sensitivity and specificity for pelvic lymph node cancer involvement. II. To evaluate 18F-fluciclovine PET imaging response and its correlation with progression free survival (defined by Prostate Cancer Working Group 2 \[PCWG2\] criteria). III. To determine if sites of progressive disease develop at the initial/prior site (diagnostic site) of metastases or in newly developed sites at the time of metastatic progression. IV. To evaluate metabolic response by 18F-fluciclovine PET semi-quantitatively with target to blood pool ratio (TBR) following ADT plus abiraterone at 22-28 weeks (+/- 4 weeks), and correlate the findings with size changes as defined by conventional imaging and PSA response. OUTLINE: Within 4 weeks before starting standard systemic therapy (SST), patients receive fluciclovine F18 intravenously (IV) then undergo a PET-CT scan over 30 minutes. Within 22-28 weeks after starting SST, patients receive fluciclovine F18 IV and undergo a second PET-CT scan over 30 minutes.
Interventions
PROCEDUREComputed Tomography
Undergo PET-CT scan
DRUGFluciclovine F18
Given IV
PROCEDUREPositron Emission Tomography
Undergo PET-CT scan
Sponsors
National Cancer Institute (NCI)
M.D. Anderson Cancer Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Histologically or cytologically proven prostate carcinoma * Documented evidence of M1 disease by American Joint Committee on Cancer (AJCC) staging by bone scan, CT and magnetic resonance imaging (MRI) * Castration naive disease, no prior systemic therapy for prostate cancer * Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1 * Ability to understand and willingness to sign informed consent
Exclusion criteria
* Known brain metastasis * Small cell carcinoma of the prostate
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Metabolic Response by Fluciclovine F18 (18F-fluciclovine) Positron Emission Tomography (PET) With Standardized Uptake Values (SUV) | Up to 2 years | Will evaluate metabolic response by 18F-fluciclovine PET qualitatively and semi-quantitatively with SUV and correlate the findings with size changes as defined by conventional imaging prostate specific antigen (PSA) response. The percentage of change in the 18F-fluciclovine maximum standardized uptake value (SUVmax) after therapy will be calculated as follows (\[pretreatment corrected SUVmax - posttreatment corrected SUVmax\]/pretreatment corrected SUVmax) x 100. Similar calculations will be performed for mean SUV, metabolic tumor volume, and total volume activity. An analysis of the quantitative data was recently performed for the 2 participants. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 18F-fluciclovine PET Imaging Response - SUVMax | Up to 2 years | Will evaluate 18F-fluciclovine PET imaging response and its correlation with progression free survival defined by Prostate Cancer Working Group 2 criteria. |
| 18F-fluciclovine PET Imaging Response - SUVMean | Up to 2 years | Will evaluate 18F-fluciclovine PET imaging response and its correlation with progression free survival defined by Prostate Cancer Working Group 2 criteria. SUVmean represents the average SUV value across a defined region of interest (ROI) in the tumor. The Measure Type is a number, that is dimensionless, because it is the average ratio of tissue activity concentration to the injected dose normalized by the patient's weight. |
| 18F-fluciclovine PET Imaging Response - Metabolic Tumor Volume | Up to 2 years | Will evaluate 18F-fluciclovine PET imaging response and its correlation with progression free survival defined by Prostate Cancer Working Group 2 criteria. |
| Sites of Progressive Disease Development | Up to 2 years | Will determine if sites of progressive disease develop at the initial/prior site (diagnostic site) of metastases or in newly developed sites at the time of metastatic progression. |
| Metabolic Response by 18F-fluciclovine PET With Target to Blood Pool Ratio (TBR) | Up to 2 years | Will evaluate metabolic response by 18F-fluciclovine PET semi-quantitatively with TBR and correlate the findings with size changes as defined by conventional imaging and PSA response. |
Countries
United States
Participant flow
Recruitment details
Medical Clinic
Pre-assignment details
No enrolled participants were excluded from the study
Participants by arm
| Arm | Count |
|---|---|
| Diagnostic (Fluciclovine F18, PET-CT) Within 4 weeks before starting SST, patients receive fluciclovine F18 IV then undergo a PET-CT scan over 30 minutes. Within 22-28 weeks after starting SST, patients receive fluciclovine F18 IV and undergo a second PET-CT scan over 30 minutes.
Computed Tomography: Undergo PET-CT scan
Fluciclovine F18: Given IV
Positron Emission Tomography: Undergo PET-CT scan | 2 |
| Total | 2 |
Baseline characteristics
| Characteristic | Diagnostic (Fluciclovine F18, PET-CT) |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 2 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants |
| Age, Continuous | 70.5 years STANDARD_DEVIATION 70.5 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 2 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 0 Participants |
| Region of Enrollment United States | 2 participants |
| Sex: Female, Male Female | 0 Participants |
| Sex: Female, Male Male | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 2 |
| other Total, other adverse events | 0 / 2 |
| serious Total, serious adverse events | 0 / 2 |
Outcome results
Primary
Metabolic Response by Fluciclovine F18 (18F-fluciclovine) Positron Emission Tomography (PET) With Standardized Uptake Values (SUV)
Will evaluate metabolic response by 18F-fluciclovine PET qualitatively and semi-quantitatively with SUV and correlate the findings with size changes as defined by conventional imaging prostate specific antigen (PSA) response. The percentage of change in the 18F-fluciclovine maximum standardized uptake value (SUVmax) after therapy will be calculated as follows (\[pretreatment corrected SUVmax - posttreatment corrected SUVmax\]/pretreatment corrected SUVmax) x 100. Similar calculations will be performed for mean SUV, metabolic tumor volume, and total volume activity. An analysis of the quantitative data was recently performed for the 2 participants.
Time frame: Up to 2 years
Population: No ROC analysis was performed due to the small number of patients. An analysis of the quantitative data was recently performed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Diagnostic (Fluciclovine F18, PET-CT) (Participant #1) | Metabolic Response by Fluciclovine F18 (18F-fluciclovine) Positron Emission Tomography (PET) With Standardized Uptake Values (SUV) | SUVmax | -69.9 percentage of change |
| Diagnostic (Fluciclovine F18, PET-CT) (Participant #1) | Metabolic Response by Fluciclovine F18 (18F-fluciclovine) Positron Emission Tomography (PET) With Standardized Uptake Values (SUV) | SUVmean | -46.3 percentage of change |
| Diagnostic (Fluciclovine F18, PET-CT) (Participant #2) | Metabolic Response by Fluciclovine F18 (18F-fluciclovine) Positron Emission Tomography (PET) With Standardized Uptake Values (SUV) | SUVmax | -50 percentage of change |
| Diagnostic (Fluciclovine F18, PET-CT) (Participant #2) | Metabolic Response by Fluciclovine F18 (18F-fluciclovine) Positron Emission Tomography (PET) With Standardized Uptake Values (SUV) | SUVmean | -37.5 percentage of change |
Secondary
18F-fluciclovine PET Imaging Response - Metabolic Tumor Volume
Will evaluate 18F-fluciclovine PET imaging response and its correlation with progression free survival defined by Prostate Cancer Working Group 2 criteria.
Time frame: Up to 2 years
Population: We compare F-18 fluciclovine PET/CT uptake (Metabolic Tumor Volume) in tumors before and after treatment.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Diagnostic (Fluciclovine F18, PET-CT) (Participant #1) | 18F-fluciclovine PET Imaging Response - Metabolic Tumor Volume | metabolic tumor volume baseline | 33.6 mL |
| Diagnostic (Fluciclovine F18, PET-CT) (Participant #1) | 18F-fluciclovine PET Imaging Response - Metabolic Tumor Volume | metabolic tumor volume posttreatment | 0.5 mL |
| Diagnostic (Fluciclovine F18, PET-CT) (Participant #2) | 18F-fluciclovine PET Imaging Response - Metabolic Tumor Volume | metabolic tumor volume baseline | 1.2 mL |
| Diagnostic (Fluciclovine F18, PET-CT) (Participant #2) | 18F-fluciclovine PET Imaging Response - Metabolic Tumor Volume | metabolic tumor volume posttreatment | 0.03 mL |
Secondary
18F-fluciclovine PET Imaging Response - SUVMax
Will evaluate 18F-fluciclovine PET imaging response and its correlation with progression free survival defined by Prostate Cancer Working Group 2 criteria.
Time frame: Up to 2 years
Population: We compare F-18 fluciclovine PET/CT uptake (SUVmax) in tumors before and after treatment.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Diagnostic (Fluciclovine F18, PET-CT) (Participant #1) | 18F-fluciclovine PET Imaging Response - SUVMax | SUVmax baseline | 10.8 ng/mL |
| Diagnostic (Fluciclovine F18, PET-CT) (Participant #1) | 18F-fluciclovine PET Imaging Response - SUVMax | SUVmax posttreatment | 4.1 ng/mL |
| Diagnostic (Fluciclovine F18, PET-CT) (Participant #2) | 18F-fluciclovine PET Imaging Response - SUVMax | SUVmax baseline | 6.6 ng/mL |
| Diagnostic (Fluciclovine F18, PET-CT) (Participant #2) | 18F-fluciclovine PET Imaging Response - SUVMax | SUVmax posttreatment | 3.3 ng/mL |
Secondary
18F-fluciclovine PET Imaging Response - SUVMean
Will evaluate 18F-fluciclovine PET imaging response and its correlation with progression free survival defined by Prostate Cancer Working Group 2 criteria. SUVmean represents the average SUV value across a defined region of interest (ROI) in the tumor. The Measure Type is a number, that is dimensionless, because it is the average ratio of tissue activity concentration to the injected dose normalized by the patient's weight.
Time frame: Up to 2 years
Population: We compare F-18 fluciclovine PET/CT uptake (SUVmean) in tumors before and after treatment.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Diagnostic (Fluciclovine F18, PET-CT) (Participant #1) | 18F-fluciclovine PET Imaging Response - SUVMean | SUVmean posttreatment | 3.2 mg/mL |
| Diagnostic (Fluciclovine F18, PET-CT) (Participant #1) | 18F-fluciclovine PET Imaging Response - SUVMean | SUVmean baseline | 4.9 mg/mL |
| Diagnostic (Fluciclovine F18, PET-CT) (Participant #2) | 18F-fluciclovine PET Imaging Response - SUVMean | SUVmean baseline | 5.2 mg/mL |
| Diagnostic (Fluciclovine F18, PET-CT) (Participant #2) | 18F-fluciclovine PET Imaging Response - SUVMean | SUVmean posttreatment | 3.3 mg/mL |
Secondary
Metabolic Response by 18F-fluciclovine PET With Target to Blood Pool Ratio (TBR)
Will evaluate metabolic response by 18F-fluciclovine PET semi-quantitatively with TBR and correlate the findings with size changes as defined by conventional imaging and PSA response.
Time frame: Up to 2 years
Population: Participant #1 underwent baseline imaging, first post-treatment and second post-treatment PET CT scans. Participant #1 second post-treatment data were not measured, since there was no target. There was no site of disease present on the second posttreatment scan, lesions resolved.~The #2 patient did not have any second posttreatment scan.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Diagnostic (Fluciclovine F18, PET-CT) (Participant #1) | Metabolic Response by 18F-fluciclovine PET With Target to Blood Pool Ratio (TBR) | Baseline | 7.66 target to blood ratio (TBR) |
| Diagnostic (Fluciclovine F18, PET-CT) (Participant #1) | Metabolic Response by 18F-fluciclovine PET With Target to Blood Pool Ratio (TBR) | First post-treatment | 1.19 target to blood ratio (TBR) |
| Diagnostic (Fluciclovine F18, PET-CT) (Participant #2) | Metabolic Response by 18F-fluciclovine PET With Target to Blood Pool Ratio (TBR) | Baseline | 4.85 target to blood ratio (TBR) |
| Diagnostic (Fluciclovine F18, PET-CT) (Participant #2) | Metabolic Response by 18F-fluciclovine PET With Target to Blood Pool Ratio (TBR) | First post-treatment | 2.04 target to blood ratio (TBR) |
Secondary
Sites of Progressive Disease Development
Will determine if sites of progressive disease develop at the initial/prior site (diagnostic site) of metastases or in newly developed sites at the time of metastatic progression.
Time frame: Up to 2 years
Population: No newly developed sites of disease were identified (no progressive disease). The primary prostate tumors were biopsied pretreatment, but not re-biopsied post-treatment. In patient#1, a left common iliac lymph node was biopsied prior to treatment, but not re-biopsied after treatment, since this lymph node resolved posttreatment. No analysis for sensitivity and specificity were performed.