Investigation of Therapy Response With Amino Acid Analogue Transport PET Imaging


Condition: Prostate Cancer

Intervention:

  • Drug: FACBC PET-CT
  • Other: MRI, CT, or Bone Scan

Purpose: 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.

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT02830880

Sponsor: Emory University

Primary Outcome Measures:

  • Measure: Change in Clinical Response assessed by FACBC PET scan
  • Time Frame: Baseline, Cycle 1 (Week 2), Cycle 6 (Week 17)
  • Safety Issue:
  • Measure: Change in Clinical Response Assessed by PSA
  • Time Frame: Baseline, Cycle 1 (Week 2), Cycle 6 (Week 17)
  • Safety Issue:
  • Measure: Change in Clinical Response Assessed by MRI
  • Time Frame: Baseline, Cycle 1 (Week 2), Cycle 6 (Week 17)
  • Safety Issue:
  • Measure: Change in Clinical Response Assessed by CT Scan
  • Time Frame: Baseline, Cycle 1 (Week 2), Cycle 6 (Week 17)
  • Safety Issue:
  • Measure: Change in Clinical Response Assessed by Bone Scan
  • Time Frame: Baseline, Cycle 1 (Week 2), Cycle 6 (Week 17)
  • Safety Issue:

Secondary Outcome Measures:

  • Measure: Mortality Rate
  • Time Frame: End of Study (up to 1 year)
  • Safety Issue:

Estimated Enrollment: 30

Study Start Date: July 2016

Phase: Phase 2

Eligibility:

  • Age: minimum 18 Years maximum N/A
  • Gender: Male

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.

Contact:

  • David Schuster, MD
  • 404-712-4859

Location:

  • Emory University Hospital
  • Atlanta Georgia 30322 United States

View trial on ClinicalTrials.gov


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