FACBC Prostate Therapy Response

December 18, 2019 updated by: David M. Schuster, MD, Emory University

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 aim to enroll thirty participants in this study.

Study Overview

Status

Completed

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

Interventional

Enrollment (Actual)

7

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Emory University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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.
Drug: FACBC PET-CT
Anti-3-[18F]FACBC is an investigational positron emission tomography (PET) radiotracer being studied given intravenously prior to PET scan.
Other Names:
  • Fluciclovine
Other: MRI, CT, or Bone Scan
Conventional imaging such as a MRI, CT, or bone scan will be performed to correlate imaging findings.

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)
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.
Baseline, Cycle 1 (Week 2), Cycle 6 (Week 17)
Prostate Specific Antigen Level
Time Frame: 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.
Baseline, Cycle 1 (Week 2), Cycle 6 (Week 17)
Number of Participants Responding to Treatment Assessed by MRI
Time Frame: 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.
Baseline, Cycle 1 (Week 2), Cycle 6 (Week 17)
Number of Participants Responding to Treatment Assessed by CT Scan
Time Frame: 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.
After Cycle 6 (Week 17)
Number of Participants With a Clinical Response Assessed by Bone Scan
Time Frame: 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.
Baseline, After Cycle 6 (Week 17)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Deaths
Time Frame: End of Study (up to 1 year)
The number of deaths that have occurred was assessed at the end of study.
End of Study (up to 1 year)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Emory University

Collaborators

Blue Earth Diagnostics
Nihon Medi-Physics Co., Ltd.

Investigators

  • Principal Investigator: David Schuster, MD, Emory University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

July 1, 2016

Primary Completion (ACTUAL)

December 1, 2018

Study Completion (ACTUAL)

September 30, 2019

Study Registration Dates

First Submitted

June 30, 2016

First Submitted That Met QC Criteria

July 8, 2016

First Posted (ESTIMATE)

July 13, 2016

Study Record Updates

Last Update Posted (ACTUAL)

January 7, 2020

Last Update Submitted That Met QC Criteria

December 18, 2019

Last Verified

December 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB00073616

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

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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