Fluciclovine (18F) PET / CT in Predicting Treatment Response in Patients with Recurrent or Metastatic Castration-Resistant Prostate Cancer Receiving Chemotherapy

Status: Temporarily Closed to Accrual

Description

This phase II trial studies the use of fluciclovine (18 fluorine [F]) positron emission tomography (PET) / computed tomography (CT) in predicting treatment response in patients with castration-resistant prostate cancer that has come back or spread to other places in the body and are receiving chemotherapy. Fluciclovine (18F) is a radiotracer that accumulates in tumor cells and may be useful in imaging tumors using PET scans. PET / CT scans make detailed, computerized pictures of areas inside the body where fluciclovine (18F) accumulates. Diagnostic procedures, such as fluciclovine (18F) PET / CT, may help doctors predict treatment response in patients receiving chemotherapy.

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
  • Patients must be able to provide written informed consent

Exclusion Criteria

  • Inability to lie still for PET scanning
  • Cannot provide written informed consent
  • Undergoing current therapy for organ confined or systemic disease; this does not preclude patients who had previously received upfront docetaxel in the hormone sensitive setting

Locations & Contacts

Georgia

Atlanta
Emory Saint Joseph's Hospital
Status: Approved
Contact: David Michael Schuster
Phone: 404-712-4859
Email: dschust@emory.edu
Emory University Hospital / Winship Cancer Institute
Status: Active
Contact: David Michael Schuster
Phone: 404-712-4859
Email: dschust@emory.edu

Trial Objectives and Outline

PRIMARY OBJECTIVES:

I. To determine if uptake on fluciclovine (18F) (anti-3-[18F]FACBC) PET-CT in metastatic lesions with castration resistant prostate carcinoma is affected by chemotherapy.

II. To determine if response on anti-3-[18F]FACBC PET scan after 1 and 6 cycles of chemotherapy (or sooner at end of chemotherapy per patient condition) correlates with clinical and imaging response after these cycles of chemotherapy as measured by standard parameters including prostate specific antigen (PSA) and routine objective measurements.

III. To determine if response on anti-3-[18F]FACBC after 1 and 6 cycles of chemotherapy (or sooner at end of chemotherapy per patient condition) correlates with clinical and imaging response to therapy at one-year as measured by standard parameters including routine objective measurements, PSA progression, clinical progression, and/or mortality.

SECONDARY OBJECTIVES:

I. To determine if uptake on the baseline anti-3-[18F]FACBC PET-CT correlates with response to chemotherapy after 6 cycles and at one year or earlier if progression as measured by standard parameters.

OUTLINE:

Patients receive docetaxel intravenously (IV) on day 1 and prednisone orally (PO) twice daily (BID) every 21 days for 6 courses. Patients receive fluciclovine (18F) IV over 1-2 minutes and then undergo PET/CT at baseline, within 14 days of the completion of course 1 of chemotherapy, and within 14 days of the completion of course 6 of chemotherapy.

After completion of study, patients are followed up for at least 1 year.

Trial Phase & Type

Trial Phase

Phase II

Trial Type

Diagnostic

Lead Organization

Lead Organization
Emory University Hospital / Winship Cancer Institute

Principal Investigator
David Michael Schuster

Trial IDs

Primary ID RAD2786-14
Secondary IDs NCI-2015-01105, IRB00073616
Clinicaltrials.gov ID NCT02830880