PET-guided radiation dose escalation linked to improved event-free survival in prostate cancer recurrence
Photo by Dmytro Vynohradov / Unsplash
Key Takeaway
Consider PET-guided RT dose escalation for prostate cancer recurrence, but note comparison is to historical control.
The EMPIRE-2 trial was a randomized study of 140 men with biochemical progression of prostate cancer after prostatectomy and negative conventional imaging findings. Patients received radiation therapy dose escalation (≥76.0 Gy to prostate bed and ≥56.0 Gy to pelvis) guided by either [F]-fluciclovine PET (59 completed RT) or [Ga]-PSMA-11 PET (60 completed RT), with median follow-up of 2.6 years.
Compared to the [F]-fluciclovine RT arm from the prior EMPIRE-1 trial (without dose escalation), the overall EMPIRE-2 cohort showed improved 2-year event-free survival (87% vs. 80%, difference 7.7%, 95% CI 4.7-12%, p=0.01). After propensity score weighting, the difference was 84% vs. 73% (difference 11%, 95% CI 3.6-24%, p=0.01). Within EMPIRE-2, there was no significant difference between the two PET tracers (87% vs. 88%, difference 0.7%, 95% CI 0.3-1.3%, p>0.9).
Safety and tolerability data were not reported. Key limitations include the comparison to a historical cohort rather than a concurrent control group, and the relatively short median follow-up of 2.6 years. The study did not report adverse events, serious adverse events, or discontinuation rates.
For practice, these results suggest that using either [F]-fluciclovine or [Ga]-PSMA-11 PET to guide radiation dose escalation to sites of PET uptake may be associated with improved event-free survival compared to approaches without dose escalation. However, the evidence comes from comparison to a historical control, and longer-term outcomes and safety data are needed before definitive conclusions can be drawn.
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View Original Abstract ↓
BACKGROUND AND OBJECTIVE: In EMPIRE-1, [F]-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 [F]-fluciclovine versus [Ga]-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 [F]-fluciclovine PET (arm 1) or [Ga]-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 [F]-fluciclovine RT arm in EMPIRE-1. The secondary endpoint was a planned EFS comparison for [F]-fluciclovine versus [Ga]-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 [F]-fluciclovine versus 88% for [Ga]-PSMA-11 (difference 0.7%, 95% CI 0.3-1.3%; p > 0.9).
CONCLUSIONS AND CLINICAL IMPLICATIONS: Use of either [F]-fluciclovine or [Ga]-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.
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