Prostate Cancer Clinical Trial

FACBC Prostate Therapy Response

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.

View Full Description

Full 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.

View Eligibility Criteria

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.

Study is for people with:

Prostate Cancer

Phase:

Phase 2

Estimated Enrollment:

7

Study ID:

NCT02830880

Recruitment Status:

Completed

Sponsor:

Emory University

Check Your Eligibility

Let’s see if you might be eligible for this study.

What is your age and gender ?

Submit

There is 1 Location for this study

See Locations Near You

Emory University Hospital
Atlanta Georgia, 30322, United States

How clear is this clinincal trial information?

Study is for people with:

Prostate Cancer

Phase:

Phase 2

Estimated Enrollment:

7

Study ID:

NCT02830880

Recruitment Status:

Completed

Sponsor:


Emory University

How clear is this clinincal trial information?

×

Introducing, the Journey Bar

Use this bar to access information about the steps in your cancer journey.

Please confirm you are a US based health care provider:

Yes, I am a health care Provider No, I am not a health care provider