Prostate Cancer
Conditions
Keywords
Imaging, Nuclear medicine, Oncology, Radiology, Urogenital disorders
Brief summary
The purpose of this study is to assess if using anti-1-amino-3-\[18F\]fluorocyclobutane-1-carboxylic acid (FACBC or fluciclovine) PET scan will be useful in determining if participants are responding to chemotherapy treatment. Investigators will enroll participants whose cancer has been treated with hormone therapy and now the cancer is not responding to the treatment (castration -resistant), and so therefore will be started on chemotherapy. Investigators aim to enroll thirty participants in this study.
Detailed description
The goal of the investigation is to examine therapeutic monitoring of chemotherapy in castrate resistant prostate carcinoma with anti-3-\[18F\]FACBC in prostate carcinoma to determine if anti-3-\[18F\]FACBC amino acid imaging can serve as an accurate and efficient imaging biomarker. Investigators will perform a baseline anti-3-\[18F\]FACBC PET-CT of the whole body. All participants will also undergo conventional staging including 99mTc methylene diphosphonate (MDP) bone scanning and computed tomography scan (CT) or magnetic resonance imaging (MR) of the abdomen and pelvis which are standard of care at the enrolling institution. This study will not interfere with standard patient evaluation or delay therapy. All 30 participants will receive chemotherapy every 3 weeks for 6 cycles. Participants will undergo a repeat anti-3-\[18F\]FACBC PET-CT after 1 and 6 cycles and also repeat conventional imaging including bone scanning CT or MR of the abdomen and pelvis after 6 cycles. At the end of the study, the study team will then record the response (or lack thereof) on anti-3-\[18F\]FACBC PET-CT and correlate that response with response per standard clinical criteria including bone scan uptake for skeletal lesions, CT or MR for soft tissue and skeletal lesions, prostate-specific antigen (PSA) progression or regression, and other clinical parameters such as declining performance status.
Interventions
DRUGFACBC PET-CT
Anti-3-\[18F\]FACBC is an investigational positron emission tomography (PET) radiotracer being studied given intravenously prior to PET scan.
OTHERMRI, CT, or Bone Scan
Conventional imaging such as a MRI, CT, or bone scan will be performed to correlate imaging findings.
Sponsors
Blue Earth Diagnostics
Nihon Medi-Physics Co., Ltd.
Emory University
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
* Primary or recurrent castration resistant prostate carcinoma with skeletal and/or nodal involvement not currently undergoing systemic chemotherapy who are about to commence therapy with docetaxel/prednisone. (Note that systemic hormonal targeted therapy including luteinizing hormone-releasing hormone (LHRH) agonists (Lupron or Trelstar), other anti-androgens, and/or Abiraterone or Enzalutamide may be in use.) * Ability to lie still for PET scanning * Ability to provide written informed consent
Exclusion criteria
* Age less than 18 years * Inability to lie still for PET scanning * Inability provide written informed consent * Currently undergoing chemotherapy for organ confined or systemic disease. This does not preclude patients who had previously received upfront docetaxel in the hormone sensitive setting.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percent Change Assessed by FACBC PET Scan | Baseline, Cycle 1 (Week 2), Cycle 6 (Week 17) | Clinical response will be assessed with FACBC PET imaging. The same measurements of the lesions and background structures will be undertaken at baseline and post-therapy scan. The researchers utilized the following parameters to follow response to therapy: maximum standardized uptake value (SUVmax) of most intense lesion each of bone and node, sum and mean SUVmax of up to 5 index lesions for each of bone and node of most intense lesion each of bone and node of the 5 index lesions for each of bone and node. SUVmax measures uptake of the radiotracer by malignant cells. Percent change after therapy, compared to baseline, was calculated and a positive percent increase indicates greater uptake of FACBC by cancer cells. |
| Prostate Specific Antigen Level | Baseline, Cycle 1 (Week 2), Cycle 6 (Week 17) | Prostate Specific Antigen (PSA) serum biomarker will be used to assess response to treatment. PSA level will be collected via blood draw. While a formal cutpoint signifying prostate cancer is not generally used as PSA levels vary between men, in general, higher PSA levels indicate prostate cancer. |
| Number of Participants Responding to Treatment Assessed by MRI | Baseline, Cycle 1 (Week 2), Cycle 6 (Week 17) | Participants will have an MRI or a CT scan to assess response to treatment. Treatment response will be reported as follows: * Complete Response (CR) Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. * Complete Response Unknown (CRU) * Partial Response (PR) At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters. * Stable Disease (NR/SD) Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD. * Progressive Disease (PD) At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this may include the baseline sum). The sum must also demonstrate an absolute increase of at least 5 mm. |
| Number of Participants Responding to Treatment Assessed by CT Scan | After Cycle 6 (Week 17) | A CT will be used to assess response to treatment. Treatment response will be reported as follows: * Complete Response (CR) Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. * Partial Response (PR) At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters. * Stable Disease (NR/SD) Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD. * Progressive Disease (PD) At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this may include the baseline sum). The sum must also demonstrate an absolute increase of at least 5 mm. |
| Number of Participants With a Clinical Response Assessed by Bone Scan | Baseline, After Cycle 6 (Week 17) | Each patient underwent 99mTc MDP whole body bone scanning at baseline, and after the 6th cycle. Bone scans findings were interpreted based on recommendations from Prostate Cancer Clinical Trial Working Group 3 (PCCTWG3) using a specialized Bone Scan Assessment Tool. The change in disease response after cycle 6 compared to the baseline assessment is presented here. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Deaths | End of Study (up to 1 year) | The number of deaths that have occurred was assessed at the end of study. |
Countries
United States
Participant flow
Recruitment details
Study participants were recruited from patients receiving services at Emory University Hospital in Atlanta, Georgia. Participant enrollment began in July 2016, follow up for the primary outcome measures was complete by December 1, 2018 and follow up for the secondary outcome measure was completed on September 30, 2019.
Participants by arm
| Arm | Count |
|---|---|
| FACBC PET-CT Participants with biopsy-proven primary or recurrent castration-resistant prostate carcinoma with skeletal and/or nodal involvement receiving Anti-3-\[18F\]FACBC radiotracer intravenously prior to PET scan. | 7 |
| Total | 7 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse reaction to chemotherapy | 1 |
| Overall Study | Death | 1 |
| Overall Study | Physician Decision | 1 |
Baseline characteristics
| Characteristic | FACBC PET-CT |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 6 Participants |
| Age, Categorical Between 18 and 65 years | 1 Participants |
| Age, Continuous | 79.0 years STANDARD_DEVIATION 5.5 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 7 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 | 1 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 | 6 Participants |
| Region of Enrollment United States | 7 Participants |
| Sex: Female, Male Female | 0 Participants |
| Sex: Female, Male Male | 7 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 3 / 7 |
| other Total, other adverse events | 0 / 7 |
| serious Total, serious adverse events | 0 / 7 |
Outcome results
Primary
Number of Participants Responding to Treatment Assessed by CT Scan
A CT will be used to assess response to treatment. Treatment response will be reported as follows: * Complete Response (CR) Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. * Partial Response (PR) At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters. * Stable Disease (NR/SD) Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD. * Progressive Disease (PD) At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this may include the baseline sum). The sum must also demonstrate an absolute increase of at least 5 mm.
Time frame: After Cycle 6 (Week 17)
Population: This analysis includes participants completing the study.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| FACBC PET-CT | Number of Participants Responding to Treatment Assessed by CT Scan | Stable Disease | 4 Participants |
| FACBC PET-CT | Number of Participants Responding to Treatment Assessed by CT Scan | Complete Response | 0 Participants |
| FACBC PET-CT | Number of Participants Responding to Treatment Assessed by CT Scan | Partial Response | 0 Participants |
| FACBC PET-CT | Number of Participants Responding to Treatment Assessed by CT Scan | Progressive Disease | 0 Participants |
Primary
Number of Participants Responding to Treatment Assessed by MRI
Participants will have an MRI or a CT scan to assess response to treatment. Treatment response will be reported as follows: * Complete Response (CR) Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. * Complete Response Unknown (CRU) * Partial Response (PR) At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters. * Stable Disease (NR/SD) Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD. * Progressive Disease (PD) At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this may include the baseline sum). The sum must also demonstrate an absolute increase of at least 5 mm.
Time frame: Baseline, Cycle 1 (Week 2), Cycle 6 (Week 17)
Population: Data were not collected for this outcome measure as all participants had a CT scan rather than an MRI to assess response to treatment.
Primary
Number of Participants With a Clinical Response Assessed by Bone Scan
Each patient underwent 99mTc MDP whole body bone scanning at baseline, and after the 6th cycle. Bone scans findings were interpreted based on recommendations from Prostate Cancer Clinical Trial Working Group 3 (PCCTWG3) using a specialized Bone Scan Assessment Tool. The change in disease response after cycle 6 compared to the baseline assessment is presented here.
Time frame: Baseline, After Cycle 6 (Week 17)
Population: This analysis includes participants who completed the study.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| FACBC PET-CT | Number of Participants With a Clinical Response Assessed by Bone Scan | Difference in disease response: None | 0 Participants |
| FACBC PET-CT | Number of Participants With a Clinical Response Assessed by Bone Scan | Difference in disease response: Response | 0 Participants |
| FACBC PET-CT | Number of Participants With a Clinical Response Assessed by Bone Scan | Difference in disease response: Stable | 2 Participants |
| FACBC PET-CT | Number of Participants With a Clinical Response Assessed by Bone Scan | Difference in disease response: Progressive | 2 Participants |
Primary
Percent Change Assessed by FACBC PET Scan
Clinical response will be assessed with FACBC PET imaging. The same measurements of the lesions and background structures will be undertaken at baseline and post-therapy scan. The researchers utilized the following parameters to follow response to therapy: maximum standardized uptake value (SUVmax) of most intense lesion each of bone and node, sum and mean SUVmax of up to 5 index lesions for each of bone and node of most intense lesion each of bone and node of the 5 index lesions for each of bone and node. SUVmax measures uptake of the radiotracer by malignant cells. Percent change after therapy, compared to baseline, was calculated and a positive percent increase indicates greater uptake of FACBC by cancer cells.
Time frame: Baseline, Cycle 1 (Week 2), Cycle 6 (Week 17)
Population: This analysis includes participants completing the study visits used in each change from baseline determination.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| FACBC PET-CT | Percent Change Assessed by FACBC PET Scan | Percent change between Baseline and Cycle 1 | 3.2 percent change of SUVmax | Standard Deviation 32.6 |
| FACBC PET-CT | Percent Change Assessed by FACBC PET Scan | Percent change between Baseline and Cycle 6 | 23.5 percent change of SUVmax | Standard Deviation 21.4 |
Primary
Prostate Specific Antigen Level
Prostate Specific Antigen (PSA) serum biomarker will be used to assess response to treatment. PSA level will be collected via blood draw. While a formal cutpoint signifying prostate cancer is not generally used as PSA levels vary between men, in general, higher PSA levels indicate prostate cancer.
Time frame: Baseline, Cycle 1 (Week 2), Cycle 6 (Week 17)
Population: This analysis includes participants completing the study visits.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| FACBC PET-CT | Prostate Specific Antigen Level | Baseline | 249.8 nanograms per milliliter (ng/mL) | Standard Deviation 471.9 |
| FACBC PET-CT | Prostate Specific Antigen Level | After completing Cycle 1 | 245.3 nanograms per milliliter (ng/mL) | Standard Deviation 472.5 |
| FACBC PET-CT | Prostate Specific Antigen Level | After completing Cycle 6 | 39.9 nanograms per milliliter (ng/mL) | Standard Deviation 23.7 |
Secondary
Number of Deaths
The number of deaths that have occurred was assessed at the end of study.
Time frame: End of Study (up to 1 year)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| FACBC PET-CT | Number of Deaths | 3 Participants |