Phase 2
Completed N=7
FACBC Prostate Therapy Response
Source: ClinicalTrials.gov NCT02830880 ↗Enrolled (actual)
7
Serious AEs
0.0%
Results posted
Dec 2019
Primary outcomePrimary: Percent Change Assessed by FACBC PET Scan — 3.2; 23.5 percent change of SUVmax
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent Change Assessed by FACBC PET Scan |
3.2; 23.5 | — |
| PRIMARY Prostate Specific Antigen Level |
249.8; 245.3; 39.9 | — |
| PRIMARY Number of Participants Responding to Treatment Assessed by MRI |
— | — |
| PRIMARY Number of Participants Responding to Treatment Assessed by CT Scan |
0; 0; 4; 0 | — |
| PRIMARY Number of Participants With a Clinical Response Assessed by Bone Scan |
0; 0; 2; 2 | — |
| SECONDARY Number of Deaths |
3 | — |
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.
Data sourced from ClinicalTrials.gov (NCT02830880). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.