Buch-Olsen Karen Middelbo, Poulsen Mads Hvid, Hansen Steinbjørn, Vilstrup Mie Holm, Holm Jorun, Hess Søren, Holdgaard Paw Christian, Zieger Karsten Egbert Arnold, Madsen Søren Sørensen, Gerke Oke, Pedersen Kasper Tholstrup, Dam Johan Hygum, Langkjær Niels, Østergaard Louise Dorner, Asmussen Jon Thor, Braad Poul Erik, Nørgaard Birgitte, Eiber Matthias, Hildebrandt Malene Grubbe
Department of Nuclear Medicine Odense University Hospital Odense C Denmark.
MANTRA - Centre for MagNetic resonance Technology for Response Adapted radiotherapy Odense University Hospital Odense Denmark.
BJUI Compass. 2023 May 12;4(5):513-522. doi: 10.1002/bco2.243. eCollection 2023 Sep.
Prostate-specific membrane antigen (PSMA)-positron emission tomography/contrast-enhanced computed tomography (PET/CT) is a sensitive imaging modality for prostate cancer (PCa). Due to lack of knowledge of the patient benefit, PSMA-PET/CT is not yet recommended in the European guidelines for staging and treatment planning of patients with newly diagnosed PCa. We will investigate the potential difference in progression-free survival (PFS) and quality of life (QoL) of using PSMA-PET/CT versus sodium fluoride (NaF)-PET/CT for staging and treatment planning in patients with newly diagnosed PCa.
This is a prospective randomised controlled multicentre trial carried out at three centres in the Region of Southern Denmark.
The primary endpoint is PFS. Secondary endpoints are residual disease, stage migration, impact on treatment strategies, stage distribution, QoL and diagnostic accuracy measures.
Patients eligible for the study have newly diagnosed unfavourable intermediate- or high-risk PCa. A total of 448 patients will be randomised 1:1 into two groups: (A) a control group staged with Na[F]F-PET/CT and (B) an intervention group staged with [F]PSMA-1007-PET/CT. A subgroup in the intervention group will have a supplementary blinded Na[F]F-PET/CT performed for the purpose of performing accuracy analyses. QoL will be assessed at baseline and with regular intervals (3-12 months) during the study period. Treatment decisions are achieved at multidisciplinary team conferences based on the results of the respective scans and according to current Danish guidelines.
The Regional Committees on Health Research Ethics for Southern Denmark (S-20190161) and the Danish Medicines Agency (EudraCT Number 2021-000123-12) approved the study, and it has been registered on clinicaltrials.gov (Record 2020110469).
前列腺特异性膜抗原（PSMA）正电子发射断层扫描/对比增强计算机断层扫描（PET/CT）是一种用于前列腺癌（PCa）的敏感成像方式。由于对患者获益缺乏了解，欧洲新诊断PCa患者分期和治疗计划指南中尚未推荐使用PSMA-PET/CT。我们将研究在新诊断PCa患者分期和治疗计划中，使用PSMA-PET/CT与氟化钠（NaF）-PET/CT相比，无进展生存期（PFS）和生活质量（QoL）的潜在差异。
这是一项在丹麦南部地区三个中心进行的前瞻性随机对照多中心试验。
主要终点是PFS。次要终点是残留疾病、分期迁移、对治疗策略的影响、分期分布、QoL和诊断准确性指标。
符合研究条件的患者为新诊断的不良中危或高危PCa患者。总共448名患者将按1:1随机分为两组：（A）对照组采用Na[F]F-PET/CT进行分期，（B）干预组采用[F]PSMA-1007-PET/CT进行分期。干预组中的一个亚组将进行补充性盲法Na[F]F-PET/CT检查，以进行准确性分析。在研究期间，将在基线以及定期（3 - 12个月）评估QoL。治疗决策在多学科团队会议上根据各自扫描结果并按照现行丹麦指南做出。
丹麦南部地区卫生研究伦理委员会（S-20190161）和丹麦药品管理局（欧盟临床试验编号2021-000123-12）批准了该研究，并且已在clinicaltrials.gov上注册（记录编号2020110469）。
