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

Jani, Ashesh B.; Schreibmann, Eduard; Goyal, Subir; Halkar, Raghuveer; Hershatter, Bruce; Rossi, Peter J.; Shelton, Joseph; Patel, Pretesh; Xu, Karen; Goodman, Mark M.; Master, Viraj A.; Joshi, Shreyas; Küçük, Ömer; Carthon, Bradley Curtis; Bilen, Mehmet Asım; Abiodun-Ojo, Olayinka; Akintayo, Akinyemi A.; Dhere, Vishal R.; Schuster, David M.

doi:10.1016/s0140-6736(21)00581-x

Cited by 123 publications

(97 citation statements)

References 29 publications

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“…Several studies have already proven that the implementation of PET/CT resulted in a significant management change rate in the postoperative setting, ranging from 35% (54) to 64% (30) (Tables 1, 2). Still, the question whether improved staging and resultant change in management can improve clinical outcomes remains at the moment unanswered and requires confirmation in prospective trials (Table 2) (54,(89)(90)(91). For example, while PET/CT restaging leads us to the definition of an entirely new population of metastatic patients, their prognosis differs dramatically from the old population of metastatic patients.…”

Section: Discussionmentioning

confidence: 99%

“…The 3-year failure-free survival was superior in patients treated with Fluciclovine PET/CT-guided SRT compared to patients treated using conventional imaging only (75.5 vs 63%). This difference widened at the 4-year evaluation (75.5 vs 51.2%, p=0.001) (54), which can be attributable to both a stage-migration phenomenon and a reduction of the in-field relapses related to the SRT dose escalation. Regardless of some inherent limitations [low proportion of patients receiving whole pelvis RT (WPRT), 25% of patients with a PSA level >1 ng/ml at salvage, lack of intent-to-treat analysis], this study can be considered hypothesis generating with respect to a possible improvement in outcomes with PET-guided SRT.…”

Section: Local Relapsementioning

confidence: 94%

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PET/CT-Based Salvage Radiotherapy for Recurrent Prostate Cancer After Radical Prostatectomy: Impact on Treatment Management and Future Directions

et al. 2021

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Biochemical recurrence is a clinical situation experienced by 20 to 40% of prostate cancer patients treated with radical prostatectomy (RP). Prostate bed (PB) radiation therapy (RT) remains the mainstay salvage treatment, although it remains non-curative for up to 30% of patients developing further recurrence. Positron emission tomography with computed tomography (PET/CT) using prostate cancer-targeting radiotracers has emerged in the last decade as a new-generation imaging technique characterized by a better restaging accuracy compared to conventional imaging. By adapting targeting of recurrence sites and modulating treatment management, implementation in clinical practice of restaging PET/CT is challenging the established therapeutic standards born from randomized controlled trials. This article reviews the potential impact of restaging PET/CT on changes in the management of recurrent prostate cancer after RP. Based on PET/CT findings, it addresses potential adaptation of RT target volumes and doses, as well as use of androgen-deprivation therapy (ADT). However, the impact of such management changes on the oncological outcomes of PET/CT-based salvage RT strategies is as yet unknown.

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Section: Discussionmentioning

confidence: 99%

Section: Local Relapsementioning

confidence: 94%

PET/CT-Based Salvage Radiotherapy for Recurrent Prostate Cancer After Radical Prostatectomy: Impact on Treatment Management and Future Directions

et al. 2021

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“…In addition to this, EMPIRE-1 is a single-center phase II/III trial that evaluated the utility of PET-directed radiotherapy in post-prostatectomy patients. In this study, 165 men with detectable PSA after prostatectomy and negative conventional imaging were randomized to radiotherapy directed by conventional imaging alone or conventional imaging and 18 F-fluciclovine-PET/CT [73]. The use of 18 F-fluciclovine-PET/CT led to a significant improvement in 3-year event-free survival (3-year event-free survival of 75.5% vs. 63%; HR for conventional imaging group: 2.05, 95% CI: 1.06-3.93) [73].…”

Section: Importance Of New Imaging Modalities and Molecular Imagingmentioning

confidence: 99%

“…In this study, 165 men with detectable PSA after prostatectomy and negative conventional imaging were randomized to radiotherapy directed by conventional imaging alone or conventional imaging and 18 F-fluciclovine-PET/CT [73]. The use of 18 F-fluciclovine-PET/CT led to a significant improvement in 3-year event-free survival (3-year event-free survival of 75.5% vs. 63%; HR for conventional imaging group: 2.05, 95% CI: 1.06-3.93) [73]. Menard et al conducted a phase II randomized controlled trial using PSMA PET/CT to intensify RT, with an objective of improving failure-free survival outcome [22].…”

Section: Importance Of New Imaging Modalities and Molecular Imagingmentioning

confidence: 99%

A Review on the Current Treatment Paradigm in High-Risk Prostate Cancer

Burgess

Roy

Morgan

et al. 2021

Cancers

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High-risk prostate cancer is traditionally treated with a combination of radiotherapy (RT) and androgen deprivation therapy (ADT). However, recent advancements in systemic treatment and radiotherapy have widened the spectrum of treatment for this patient population. Use of image guidance and intensity modulation, as well as the incorporation of brachytherapy, has led to safe radiotherapy dose escalation with reduced risk of recurrence. Clinical trials have helped define the role of pelvic nodal radiotherapy, the role of stereotactic ablative radiotherapy, and the optimal duration and sequencing of ADT in combination with radiotherapy. Emerging evidence has redefined the role of surgery in this cohort. Contemporary clinical trials have identified new systemic therapy options in high-risk prostate cancer. Finally, new imaging modalities including multi-parametric MRI and molecular imaging and genomic classifiers have ushered a new era in patient selection, risk stratification, and treatment tailoring.

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“…Positron emission tomography / computed tomography (PET/CT) permits the measurement of physiological parameters through a dynamic study of tracer dynamics, which is a great advantage over other imaging modalities [6]. In 2019, United Imaging Healthcare released the world's rst total-body PET / CT scanner, named uEXPLORER [7].…”

Section: Introductionmentioning

confidence: 99%

Identification of Genes Related to 68Ga-DOTATATE Organ Distribution in Homo Sapiens

Huang

2021

Preprint

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Purpose 68Ga-DOTATATE is a somatostatin analogue that has been used for imaging neuroendocrine tumours. However, there is nonspecific uptake in some organs, and the reasons for that are not clear. The aim of the study is to outline the dynamic distribution pattern of 68Ga-DOTATATE in human body, and identify the genes responsible for 68Ga-DOTATATE uptake by bioinformatics analysis.Methods 68Ga-DOTATATE PET/CT was performed in 32 patients, and dynamic total-body PET scanning was performed with uEXPLORER. The gene expression datasets of human organs were downloaded from the Human Protein Atlas. WGCNA analysis was performed to screen the potential genes related to 68Ga-DOTATATE. BindingDB, SEA and SwissTargetPrediction databases were used to predict the potential binding proteins of DOTATATE based on molecular structure. Results Dynamic total-body PET scanning showed that 68Ga-DOTATATE uptake was not consistent with expression of SSTR2 in human organs. WGCNA analysis revealed 800 genes whose expression level was positively correlated to 68Ga-DOTATATE uptake. According to the molecular structure of DOTATATE, 135 proteins with potential binding ability to DOTATATE were screened by analysis based on drug database. Based on the results of the above two parts, 8 proteins were finally obtained, respectively AVPR1A, EPHA8, EPHB4, OPRL1, SSTR2, SSTR5, ST3GAL1 and NPY1R, which had potential binding possibility with DOTATATE, and their expression was positively correlated with 68Ga-DOTATATE uptake.Conclusion WGCNA analysis was combined with the drug database to obtain new potential binding targets of DOTATATE. The bioinformatics approach developed in this study could potentially be used to discover new potential binding targets for molecular imaging agents.

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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

Cited by 123 publications

References 29 publications

PET/CT-Based Salvage Radiotherapy for Recurrent Prostate Cancer After Radical Prostatectomy: Impact on Treatment Management and Future Directions

PET/CT-Based Salvage Radiotherapy for Recurrent Prostate Cancer After Radical Prostatectomy: Impact on Treatment Management and Future Directions

A Review on the Current Treatment Paradigm in High-Risk Prostate Cancer

Identification of Genes Related to 68Ga-DOTATATE Organ Distribution in Homo Sapiens

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