European urology · 2025
[18F]-Fluciclovine or [68Ga]-PSMA-11 Molecular Imaging To Guide Dose Escalation of Salvage Radiotherapy After Radical Prostatectomy for Prostate Cancer: The EMPIRE-2 Trial.
СтатьяРандомизированное исследованиеСравнительное исследованиеНазвание и аннотация: Перевод в очереди
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Jani Ashesh B, Dhere Vishal R, Goyal Subir, Schreibmann Eduard, Patel Pretesh R, Hershatter Bruce, Shelton Joseph W, Hanasoge Sheela, Sebastian Nikhil T, Patel Sagar A, Halkar Raghuveer, Cooper Sherrie, Fielder Bridget, Abiodun-Ojo Olayinka A, Lawal Ismaheel, Mushtaq Aliza, Master Viraj A, Joshi Shreyas S, Kucuk Omer, Bilen Mehmet A, Schuster David M
Аннотация
BACKGROUND AND OBJECTIVE: In EMPIRE-1, [18F]-fluciclovine positron emission tomography (PET) imaging to guide salvage radiotherapy (RT) for prostate cancer recurrence after prostatectomy resulted in an improvement in event-free survival (EFS) over conventional imaging alone. The aim of EMPIRE-2 was to explore the impact of RT dose escalation to sites of uptake on PET in comparison to EMPIRE-1.
METHODS: EMPIRE-2 was a randomized trial of [18F]-fluciclovine versus [68Ga]-PSMA-11 in a cohort of men with biochemical progression after prostatectomy and negative conventional imaging findings. After stratification, patients were randomized to RT guided by [18F]-fluciclovine PET (arm 1) or [68Ga]-PSMA-11 PET (arm 2). PET findings were used for treatment decisions and for RT dose escalation (≤76.0 Gy to the prostate bed and ≤56.0 Gy to the pelvis). The primary endpoint was 2-yr EFS in comparison to the [18F]-fluciclovine RT arm in EMPIRE-1. The secondary endpoint was a planned EFS comparison for [18F]-fluciclovine versus [68Ga]-PSMA-11 in EMPIRE-2.
KEY FINDINGS AND LIMITATIONS: In the cohort of 140 patients, 59 randomized to arm 1 patients and 60 randomized to arm 2 completed RT. Median follow-up was 2.6 yr (interquartile range 1.8-4.0). The 2-yr EFS rates were 87% for the overall EMPIRE-2 cohort versus 80% for the EMPIRE-1 comparison cohort (difference 7.7%, 95% confidence interval [CI] 4.7-12%; p = 0.01). After propensity score weighting, the corresponding 2-yr EFS rates were 84% versus 73% (difference 11%, 95% CI 3.6-24%; p = 0.01). The 2-yr EFS rates in the EMPIRE-2 study arms were 87% for [18F]-fluciclovine versus 88% for [68Ga]-PSMA-11 (difference 0.7%, 95% CI 0.3-1.3%; p > 0.9).
CONCLUSIONS AND CLINICAL IMPLICATIONS: Use of either [18F]-fluciclovine or [68Ga]-PSMA-11 imaging to guide RT dose escalation to sites of PET uptake in the prostate bed and/or pelvis was associated with an improvement in EFS in comparison to a prior trial without dose escalation.
METHODS: EMPIRE-2 was a randomized trial of [18F]-fluciclovine versus [68Ga]-PSMA-11 in a cohort of men with biochemical progression after prostatectomy and negative conventional imaging findings. After stratification, patients were randomized to RT guided by [18F]-fluciclovine PET (arm 1) or [68Ga]-PSMA-11 PET (arm 2). PET findings were used for treatment decisions and for RT dose escalation (≤76.0 Gy to the prostate bed and ≤56.0 Gy to the pelvis). The primary endpoint was 2-yr EFS in comparison to the [18F]-fluciclovine RT arm in EMPIRE-1. The secondary endpoint was a planned EFS comparison for [18F]-fluciclovine versus [68Ga]-PSMA-11 in EMPIRE-2.
KEY FINDINGS AND LIMITATIONS: In the cohort of 140 patients, 59 randomized to arm 1 patients and 60 randomized to arm 2 completed RT. Median follow-up was 2.6 yr (interquartile range 1.8-4.0). The 2-yr EFS rates were 87% for the overall EMPIRE-2 cohort versus 80% for the EMPIRE-1 comparison cohort (difference 7.7%, 95% confidence interval [CI] 4.7-12%; p = 0.01). After propensity score weighting, the corresponding 2-yr EFS rates were 84% versus 73% (difference 11%, 95% CI 3.6-24%; p = 0.01). The 2-yr EFS rates in the EMPIRE-2 study arms were 87% for [18F]-fluciclovine versus 88% for [68Ga]-PSMA-11 (difference 0.7%, 95% CI 0.3-1.3%; p > 0.9).
CONCLUSIONS AND CLINICAL IMPLICATIONS: Use of either [18F]-fluciclovine or [68Ga]-PSMA-11 imaging to guide RT dose escalation to sites of PET uptake in the prostate bed and/or pelvis was associated with an improvement in EFS in comparison to a prior trial without dose escalation.