Clinical trial · Interventional
FACBC Prostate Therapy Response
Investigation of Therapy Response With Amino Acid Analogue Transport PET Imaging
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| FACBC PET-CT | Drug | — | UNRESOLVED |
| MRI, CT, or Bone Scan | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- FACBC
- description
- Participants with biopsy-proven primary or recurrent castration-resistant prostate carcinoma with skeletal and/or nodal involvement will undergo an FACBC PET-CT scan.
- interventionNames
- Drug: FACBC PET-CT
- Other: MRI, CT, or Bone Scan
Primary outcomes (5)
- measure
- Percent Change Assessed by FACBC PET Scan
- timeFrame
- Baseline, Cycle 1 (Week 2), Cycle 6 (Week 17)
- description
- Clinical response will be assessed with FACBC PET imaging. The same measurements of the lesions and background structures will be undertaken at baseline and post-therapy scan. The researchers utilized the following parameters to follow response to therapy: maximum standardized uptake value (SUVmax) of most intense lesion each of bone and node, sum and mean SUVmax of up to 5 index lesions for each of bone and node of most intense lesion each of bone and node of the 5 index lesions for each of bone and node. SUVmax measures uptake of the radiotracer by malignant cells. Percent change after therapy, compared to baseline, was calculated and a positive percent increase indicates greater uptake of FACBC by cancer cells.
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (1)
- BACKGROUNDSchuster DM, Nieh PT, Jani AB, Amzat R, Bowman FD, Halkar RK, Master VA, Nye JA, Odewole OA, Osunkoya AO, Savir-Baruch B, Alaei-Taleghani P, Goodman MM. Anti-3-[(18)F]FACBC positron emission tomography-computerized tomography and (111)In-capromab pendetide single photon emission computerized tomography-computerized tomography for recurrent prostate carcinoma: results of a prospective clinical trial. J Urol. 2014 May;191(5):1446-53. doi: 10.1016/j.juro.2013.10.065. Epub 2013 Oct 19. PMID 24144687