Metastatic Prostate Carcinoma, Prostate Carcinoma Metastatic in the Bone, Stage IV Prostate Cancer
Conditions
Brief summary
This trial studies how well fluciclovine 18F PET/CT imaging works in assessing hormone-naive men with prostate cancer that has spread to the bone. Fluciclovine 18F is a radioactive drug used to measure tumor growth. PET/CT uses x-rays to take pictures inside the body. Comparing results of fluciclovine 18F PET/CT imaging may help doctors predict a patient's response to treatment and help plan the best treatment.
Detailed description
PRIMARY OBJECTIVES: I. Abnormal fluciclovine F18 (\[18F\] fluciclovine) uptake on visual assessment will differ by the type of metastatic lesion present (blastic, lytic, marrow, mixed). II. Maximum standardized uptake value (SUVmax) and mean standardized uptake value (SUVmean) on (18F) fluciclovine-positron emission tomography (PET)/computed tomography (CT) imaging will differ by the type of metastatic lesion present (blastic, lytic, marrow, mixed). SECONDARY OBJECTIVES: I. Determine if a 25% or greater reduction in average (ave) SUVmax or ave SUVmean on (18F) fluciclovine-PET/CT imaging after completion of all radiation therapy will be predictive of increased time to biochemical failure. II. Determine the correlation between the number of lesions, their visual uptake, and semi-quantitative uptake on technetium tc-99m medronate (99mTc-MDP) bone scintigraphy and (18F) fluciclovine- PET/CT at baseline. III. Determine the correlation between the number of lesions, their visual uptake, and semi-quantitative uptake on 99mTc-MDP bone scintigraphy and (18F) fluciclovine- PET/CT after 3 and 6 cycles of treatment. OUTLINE: This is a companion imaging study to Institutional Review Board (IRB) #102312 (A Phase 2 Study of Radium-223 and Radiotherapy in Hormone-Naive Men with Oligometastatic Prostate Cancer to Bone). Patients receive fluciclovine F18 intravenously (IV) over 30 seconds and undergo PET/CT scan over 60 minutes at baseline, 3 months and at approximately 6 months of radium-223 therapy. After completion of diagnostic testing, patients are followed for 2 years.
Interventions
PROCEDUREComputed Tomography
Undergo PET/CT scan
DRUGFluciclovine F18
Given IV
PROCEDUREPositron Emission Tomography
Undergo PET/CT scan
Sponsors
University of Utah
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
MALE
Healthy volunteers
No
Inclusion criteria
* Enrollment on IRB #102312 (A Phase 2 Study of Radium-223 and Radiotherapy in Hormone-Naive Men with Oligometastatic Prostate Cancer to Bone). * Patients must document their willingness to be followed for up to 24 months after recruitment by signing informed consent documenting their agreement to allow access to the data obtained on IRB #102312 and information and data entered into a research database. * All patients, or their legal guardians, must sign a written informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization in accordance with institutional guidelines.
Exclusion criteria
* Patients with known allergic or hypersensitivity reactions to previously administered radiopharmaceuticals. Patients with significant drug or other allergies or autoimmune diseases may be enrolled at the Investigator?s discretion. * Patients who require monitored anesthesia for PET scanning. * Patients who are too claustrophobic to undergo PET scanning.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Standardized Uptake Value (SUVmean) by Lesion Type | Participants were assessed using [18F]Fluciclovine-PET/CT at baseline, prior to initiating radium-223 therapy | Mean SUV values are reported according to the type of bone lesion (osteoblastic dense, osteoblastic ground glass, osteoblastic mixed, and osteolytic). |
| Maximum Standardized Uptake Value (SUVmax) by Lesion Type | Participants were assessed using [18F]Fluciclovine-PET/CT at baseline, prior to initiating radium-223 therapy | Maximum SUV values are reported according to the type of bone lesion (osteoblastic dense, osteoblastic ground glass, osteoblastic mixed, and osteolytic). |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Diagnostic (Fluciclovine F18, PET/CT) Patients receive fluciclovine F18 intravenously (IV) over 30 seconds and undergo PET/CT scan over 60 minutes at baseline, 3 months and at approximately 6 months of radium-223 therapy.
Computed Tomography: Undergo PET/CT scan
Fluciclovine F18: Given IV
Positron Emission Tomography: Undergo PET/CT scan | 17 |
| Total | 17 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Withdrawal by Subject | 2 |
Baseline characteristics
| Characteristic | Diagnostic (Fluciclovine F18, PET/CT) |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 14 Participants |
| Age, Categorical Between 18 and 65 years | 3 Participants |
| Age, Continuous | 70.41 years STANDARD_DEVIATION 6.19 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 16 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 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 | 1 Participants |
| Race (NIH/OMB) White | 16 Participants |
| Region of Enrollment United States | 17 participants |
| Sex: Female, Male Female | 0 Participants |
| Sex: Female, Male Male | 17 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 17 |
| other Total, other adverse events | 0 / 17 |
| serious Total, serious adverse events | 0 / 17 |
Outcome results
Primary
Maximum Standardized Uptake Value (SUVmax) by Lesion Type
Maximum SUV values are reported according to the type of bone lesion (osteoblastic dense, osteoblastic ground glass, osteoblastic mixed, and osteolytic).
Time frame: Participants were assessed using [18F]Fluciclovine-PET/CT at baseline, prior to initiating radium-223 therapy
Population: The \[18F\]Fluciclovine-PET/CT scans were evaluated for 17 enrolled participants. The 19 lesions seen on PET that had a definitive CT correlate were categorized by lesion type. The number of units analyzed for each row reflect the number of lesions in each category. Some participants had multiple lesions of different types.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Diagnostic (Fluciclovine F18, PET/CT) | Maximum Standardized Uptake Value (SUVmax) by Lesion Type | Osteoblastic Dense | 4.80 SUV by body weight (kg) | Standard Deviation 1.53 |
| Diagnostic (Fluciclovine F18, PET/CT) | Maximum Standardized Uptake Value (SUVmax) by Lesion Type | Osteoblastic Ground Glass | 7.17 SUV by body weight (kg) | Standard Deviation 3.75 |
| Diagnostic (Fluciclovine F18, PET/CT) | Maximum Standardized Uptake Value (SUVmax) by Lesion Type | Osteoblastic Mixed | 8.39 SUV by body weight (kg) | Standard Deviation 5.61 |
| Diagnostic (Fluciclovine F18, PET/CT) | Maximum Standardized Uptake Value (SUVmax) by Lesion Type | Osteolytic | 10.02 SUV by body weight (kg) | Standard Deviation 3.33 |
Primary
Mean Standardized Uptake Value (SUVmean) by Lesion Type
Mean SUV values are reported according to the type of bone lesion (osteoblastic dense, osteoblastic ground glass, osteoblastic mixed, and osteolytic).
Time frame: Participants were assessed using [18F]Fluciclovine-PET/CT at baseline, prior to initiating radium-223 therapy
Population: The \[18F\]Fluciclovine-PET/CT scans were evaluated for 17 enrolled participants. The 19 lesions seen on PET that had a definitive CT correlate were categorized by lesion type. The number of units analyzed for each row reflect the number of lesions in each category. Some participants had multiple lesions of different types.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Diagnostic (Fluciclovine F18, PET/CT) | Mean Standardized Uptake Value (SUVmean) by Lesion Type | Osteoblastic Dense | 1.91 SUV by body weight (kg) | Standard Deviation 0.69 |
| Diagnostic (Fluciclovine F18, PET/CT) | Mean Standardized Uptake Value (SUVmean) by Lesion Type | Osteoblastic Ground Glass | 2.36 SUV by body weight (kg) | Standard Deviation 1.12 |
| Diagnostic (Fluciclovine F18, PET/CT) | Mean Standardized Uptake Value (SUVmean) by Lesion Type | Osteoblastic Mixed | 2.63 SUV by body weight (kg) | Standard Deviation 1.26 |
| Diagnostic (Fluciclovine F18, PET/CT) | Mean Standardized Uptake Value (SUVmean) by Lesion Type | Osteolytic | 3.05 SUV by body weight (kg) | Standard Deviation 0.43 |