drugset / Trial / NCT01666808
FACBC Outcomes for Post Prostatectomy
RandomizedSingle-groupOpen-labelTreatment
Summary
Investigators will perform a study with 162 patients in whom there is a strong suspicion of prostate cancer that has returned to the body after having a prostatectomy. Half of these patients will have radiotherapy decision-making and delivery per the usual routine, and half of these patients will have the radiotherapy decision and volumes guided by the FACBC test (anti-1-amino-3-\[18F\]fluorocyclobutane-1-carboxylic acid (anti-3- \[18F\]FACBC). The major goal of the investigation is to see whether the FACBC improves the selection and the cancer control rates of post-surgery patients with a rising PSA who undergo radiotherapy.
Timeline
- Start
- 2012-09
- Primary completion
- 2022-04-18
- Completion
- 2022-04-18
Publications
- Results Jani AB, Schreibmann E, Goyal S, Halkar R, Hershatter B, Rossi PJ, Shelton JW, Patel PR, Xu KM, Goodman M, Master VA, Joshi SS, Kucuk O, Carthon BC, Bilen MA, Abiodun-Ojo OA, Akintayo AA, Dhere VR, Schuster DM. 18F-fluciclovine-PET/CT imaging versus conventional imaging alone to guide postprostatectomy salvage radiotherapy for prostate cancer (EMPIRE-1): a single centre, open-label, phase 2/3 randomised controlled trial. Lancet. 2021 May 22;397(10288):1895-1904. doi: 10.1016/S0140-6736(21)00581-X. Epub 2021 May 7.
- Results Dhere VR, Schuster DM, Goyal S, Schreibmann E, Hershatter BW, Rossi PJ, Shelton JW, Patel PR, Jani AB. Randomized Trial of Conventional Versus Conventional Plus Fluciclovine (18F) Positron Emission Tomography/Computed Tomography-Guided Postprostatectomy Radiation Therapy for Prostate Cancer: Volumetric and Patient-Reported Analyses of Toxic Effects. Int J Radiat Oncol Biol Phys. 2022 Aug 1;113(5):1003-1014. doi: 10.1016/j.ijrobp.2022.04.005. Epub 2022 Apr 11.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | 18F-fluciclovine | Diagnostic / imaging agent | — | Intravenous |