1. Utility of 18F-Fluciclovine PET/MRI for Staging Newly Diagnosed High-Risk Prostate Cancer and Evaluating Response to Initial Androgen Deprivation Therapy: A Prospective Single-Arm Pilot Study
- Author
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Kristin K. Porter, Constantine M. Burgan, Samuel J. Galgano, Soroush Rais-Bahrami, Jonathan McConathy, Gagandeep Choudhary, Pradeep Bhambhvani, Yufeng Li, John V. Thomas, Desiree E. Morgan, Jeffrey W. Nix, and Andrew M. McDonald
- Subjects
Male ,Risk ,Oncology ,Biochemical recurrence ,medicine.medical_specialty ,Carboxylic Acids ,MEDLINE ,Pilot Projects ,Disease ,Newly diagnosed ,Multimodal Imaging ,Article ,030218 nuclear medicine & medical imaging ,Androgen deprivation therapy ,03 medical and health sciences ,Prostate cancer ,0302 clinical medicine ,Internal medicine ,medicine ,Humans ,Radiology, Nuclear Medicine and imaging ,Prospective Studies ,Aged ,Neoplasm Staging ,Aged, 80 and over ,business.industry ,Prostate ,Prostatic Neoplasms ,Androgen Antagonists ,General Medicine ,Middle Aged ,medicine.disease ,Magnetic Resonance Imaging ,Treatment Outcome ,Positron-Emission Tomography ,030220 oncology & carcinogenesis ,Radiopharmaceuticals ,business ,Cyclobutanes - Abstract
BACKGROUND. Despite advances in prostate cancer treatment, rates of biochemical recurrence remain high, relating to lack of detection of small-volume metastatic disease using conventional imaging for initial staging. OBJECTIVE. The purpose of this study was to assess the potential use of (18)F-fluciclovine PET/MRI for initial staging of high-risk prostate cancer and evaluating response to androgen deprivation therapy (ADT). METHODS. This prospective clinical trial enrolled 14 men with newly diagnosed high-risk prostate cancer and negative or equivocal conventional staging imaging for metastatic disease between January 2018 and February 2019. All patients underwent pretreatment (18)F-fluciclovine PET/MRI including multiparametric prostate MRI; 12 underwent (18)F-fluciclovine PET/MRI after surgery or between ADT and radiotherapy. Confidence in identification of the primary intraprostatic lesion and nodal metastases was independently rated on a 0–3 Likert scale by three readers with nuclear medicine experience for (18)F-fluciclovine PET/MRI and three readers with abdominal imaging experience for MRI alone. Findings scored as 2 or 3 by at least two readers of a given modality were considered positive. A single reader measured SUV(mean), SUV(max), and volume of the MRI-defined intraprostatic lesion and SUV(max) of suspicious lymph nodes on PET before and after initiation of ADT. Changes in SUV were analyzed using nonparametric Wilcoxon signed-rank tests. RESULTS. The biopsy-proven lesion in the prostate gland was accurately identified in all 14 patients on both MRI and (18)F-fluciclovine PET/MRI. Suspected nodal metastases were detected in three patients on MRI and seven patients on (18)F-fluciclovine PET/MRI. After ADT, all patients showed decreased activity within the intraprostatic lesion and/or all suspicious lymph nodes. The primary lesion SUV(mean) was 4.5 ± 1.1 (range, 2.7–6.5) before treatment and 2.4 ± 1.1 (range, 0.0–3.6) after initiation of ADT (p = .008). For suspicious lymph nodes, the pretreatment SUV(max) was 5.5 ± 3.7 (range, 2.8–12.7) and the posttreatment SUV(max) was 2.8 ± 1.4 (range, 1.4–5.5) (p = .03). CONCLUSION. (18)F-labeled fluciclovine PET/MRI shows potential utility in initial staging of high-risk prostate cancer and in evaluating response to ADT. CLINICAL IMPACT. Given the FDA approval and widespread availability of (18)F-fluciclovine, the findings could have an impact in the immediate future in guiding initial management of patients with prostate cancer. TRIAL REGISTRATION. ClinicalTrials.gov NCT03264456
- Published
- 2021
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