FACBC Prostate Therapy Response
| Status: | Recruiting |
|---|---|
| Conditions: | Prostate Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 8/2/2018 |
| Start Date: | July 2016 |
| End Date: | December 2021 |
| Contact: | David Schuster, MD |
| Email: | dschust@emory.edu |
| Phone: | 404-712-4859 |
Investigation of Therapy Response With Amino Acid Analogue Transport PET Imaging
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 will enroll thirty (30) participants in this
study.
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 will enroll thirty (30) participants in this
study.
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 MDP bone scanning and cat
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.
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 MDP bone scanning and cat
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.
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.
We found this trial at
1
site
1364 Clifton Rd NE
Atlanta, Georgia 30322
Atlanta, Georgia 30322
(404) 712-2000
Principal Investigator: David M Schuster, MD
Phone: 404-778-5625
Emory University Hospital As the largest health care system in Georgia and the only health...
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