Clinical trial NCT02830880: FACBC Prostate Therapy Response
Official title: Investigation of Therapy Response With Amino Acid Analogue Transport PET Imaging
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Prostate Cancer
Keywords: Imaging
Nuclear medicine
Oncology
Radiology
Urogenital disorders
Lead sponsor: Emory University
Sponsor class: OTHER
Collaborators: name: Blue Earth Diagnostics
name: Nihon Medi-Physics Co., Ltd.
First posted: 2016-07-13
Enrollment: 7
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Percent Change Assessed by FACBC PET Scan
timeFrame: Baseline, Cycle 1 (Week 2), Cycle 6 (Week 17)
measure: Prostate Specific Antigen Level
timeFrame: Baseline, Cycle 1 (Week 2), Cycle 6 (Week 17)
measure: Number of Participants Responding to Treatment Assessed by MRI
timeFrame: Baseline, Cycle 1 (Week 2), Cycle 6 (Week 17)
measure: Number of Participants Responding to Treatment Assessed by CT Scan
timeFrame: After Cycle 6 (Week 17)
measure: Number of Participants With a Clinical Response Assessed by Bone Scan
timeFrame: Baseline, After Cycle 6 (Week 17)
Secondary outcomes:
measure: Number of Deaths
timeFrame: End of Study (up to 1 year)
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Emory University Hospital
state: Georgia
Study officials:
affiliation: Emory University
name: David Schuster, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Schuster DM, Nieh PT, Jani AB, Amzat R, Bowman FD, Halkar RK, Master VA, Nye JA, Odewole OA, Osunkoya AO, Savir-Baruch B, Alaei-Taleghani P, Goodman MM. Anti-3-[(18)F]FACBC positron emission tomography-computerized tomography and (111)In-capromab pendetide single photon emission computerized tomography-computerized tomography for recurrent prostate carcinoma: results of a prospective clinical trial. J Urol. 2014 May;191(5):1446-53. doi: 10.1016/j.juro.2013.10.065. Epub 2013 Oct 19.