Georgia's Online Cancer Information Center

Find A Clinical Trial

Investigation of Therapy Response with Amino Acid Analogue Transport PET Imaging

Status
Temporarily Closed
Cancer Type
Prostate Cancer
Trial Phase
Phase II
Eligibility
18 and over, Male
Study Type
Diagnostic
NCD ID
NCT02830880
Protocol IDs
RAD2786-14 (primary)
NCI-2015-01105
IRB00073616
Study Sponsor
Emory University/Winship Cancer Institute

Summary

This clinical trial studies the use of fluciclovine (18 fluorine [F]) positron emission tomography (PET)/computed tomography (CT) in predicting treatment response in patients with hormone-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.

Objectives

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 4 cycles of chemotherapy correlates with clinical and imaging response after 4 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 4 cycles of chemotherapy 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 mortality.

SECONDARY OBJECTIVES:

I. To determine if uptake on the baseline anti-3-[18F]FACBC PET-CT correlates with response to chemotherapy after 4 cycles and at one year as measured by standard parameters.

OUTLINE:

Patients receive fluciclovine (18F) intravenously (IV) over 1-2 minutes and then undergo PET/CT at baseline, within 7 days of the completion of the first course of chemotherapy*, and within 14 days of the completion of the fourth course of chemotherapy.

*Note: Patients receive docetaxel IV on day 1 and prednisone orally (PO) twice daily (BID) every 21 days for 4 courses.

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

Georgia CORE

 

Hearts and Minds Dedicated to Improving Cancer Care

Georgia CORE is a public-private partnership that creates collaboration among the state’s cancer organizations and institutions to connect more Georgians to quality, personalized cancer care. We welcome you to this one-of-a-kind online information center for all things related to cancer and survivorship care in Georgia.