Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2019-06047 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| 2019-0030 | Other Identifier | M D Anderson Cancer Center |
Not provided
Not provided
Not provided
Slow accrual
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Diagnostic (fluciclovine F18, PET-CT) | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Computed Tomography | Procedure | Undergo PET-CT scan |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Up to 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Up to 2 years |
| 18F-fluciclovine PET Imaging Response - SUVMean |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Gregory C Ravizzini | M.D. Anderson Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| M D Anderson Cancer Center | Houston | Texas | 77030 | United States |
Not provided
| Label | URL |
|---|---|
| MD Anderson Cancer Center Website | View source |
Not provided
No enrolled participants were excluded from the study
Medical Clinic
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 28, 2021 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Fluciclovine F18 | Drug | Given IV |
|
|
| Positron Emission Tomography | Procedure | Undergo PET-CT scan |
|
|
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. |
| Up to 2 years |
| 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. | Up to 2 years |
| 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. | Up to 2 years |
| 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. | Up to 2 years |
| COMPLETED |
|
| NOT COMPLETED |
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||||||
| Age, Continuous | Median | Standard Deviation | years |
| |||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||||
| Region of Enrollment | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | No ROC analysis was performed due to the small number of patients. An analysis of the quantitative data was recently performed. | Posted | Number | percentage of change | Up to 2 years |
|
|
| ||||||||||||||||||||||||||||||||||||
| 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. | We compare F-18 fluciclovine PET/CT uptake (SUVmax) in tumors before and after treatment. | Posted | Number | ng/mL | Up to 2 years |
| ||||||||||||||||||||||||||||||||||||||
| 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. | We compare F-18 fluciclovine PET/CT uptake (SUVmean) in tumors before and after treatment. | Posted | Number | mg/mL | Up to 2 years |
| ||||||||||||||||||||||||||||||||||||||
| 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. | We compare F-18 fluciclovine PET/CT uptake (Metabolic Tumor Volume) in tumors before and after treatment. | Posted | Number | mL | Up to 2 years |
| ||||||||||||||||||||||||||||||||||||||
| 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. | 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. | Posted | Up to 2 years |
|
| |||||||||||||||||||||||||||||||||||||||
| 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. | 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. | Posted | Number | target to blood ratio (TBR) | Up to 2 years |
|
7 months
No Adverse Events were observed or reported
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 | 0 | 2 | 0 | 2 | 0 | 2 |
Not provided
Not provided
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Gregory Ravizzini | The University of Texas M D Anderson Cancer Center | (713) 518-9866 | gravizzini@mdanderson.org |
| Jun 20, 2024 |
| Prot_SAP_006.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jan 26, 2021 | Oct 7, 2024 | ICF_007.pdf |
Not provided
| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C117460 | fluciclovine F-18 |
| D009682 | Magnetic Resonance Spectroscopy |
| ID | Term |
|---|---|
| D013057 | Spectrum Analysis |
| D002623 | Chemistry Techniques, Analytical |
| D008919 | Investigative Techniques |
Not provided
Not provided
| Unknown or Not Reported |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
|
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
|
|