- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02830880
FACBC Prostate Therapy Response
Investigation of Therapy Response With Amino Acid Analogue Transport PET Imaging
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
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Georgia
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Atlanta, Georgia, United States, 30322
- Emory University Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: DIAGNOSTIC
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: FACBC
Participants with biopsy-proven primary or recurrent castration-resistant prostate carcinoma with skeletal and/or nodal involvement will undergo an FACBC PET-CT scan.
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Anti-3-[18F]FACBC is an investigational positron emission tomography (PET) radiotracer being studied given intravenously prior to PET scan.
Other Names:
Conventional imaging such as a MRI, CT, or bone scan will be performed to correlate imaging findings.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percent Change Assessed by FACBC PET Scan
Time Frame: Baseline, Cycle 1 (Week 2), Cycle 6 (Week 17)
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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.
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Baseline, Cycle 1 (Week 2), Cycle 6 (Week 17)
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Prostate Specific Antigen Level
Time Frame: Baseline, Cycle 1 (Week 2), Cycle 6 (Week 17)
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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.
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Baseline, Cycle 1 (Week 2), Cycle 6 (Week 17)
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Number of Participants Responding to Treatment Assessed by MRI
Time Frame: Baseline, Cycle 1 (Week 2), Cycle 6 (Week 17)
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Participants will have an MRI or a CT scan to assess response to treatment. Treatment response will be reported as follows:
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Baseline, Cycle 1 (Week 2), Cycle 6 (Week 17)
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Number of Participants Responding to Treatment Assessed by CT Scan
Time Frame: After Cycle 6 (Week 17)
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A CT will be used to assess response to treatment. Treatment response will be reported as follows:
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After Cycle 6 (Week 17)
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Number of Participants With a Clinical Response Assessed by Bone Scan
Time Frame: Baseline, After Cycle 6 (Week 17)
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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.
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Baseline, After Cycle 6 (Week 17)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Deaths
Time Frame: End of Study (up to 1 year)
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The number of deaths that have occurred was assessed at the end of study.
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End of Study (up to 1 year)
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: David Schuster, MD, Emory University
Publications and helpful links
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB00073616
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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