18F-fluoride positron emission tomography/computed tomography and bone scintigraphy for diagnosis of bone metastases in newly diagnosed, high-risk prostate cancer patients: study protocol for a multicentre, diagnostic test accuracy study

BMC Cancer

Study Protocol

Randi F. Fonager¹  Helle D. Zacho²  Lars J. Petersen²  Niels C. Langkilde³ 

[1] Department of Nuclear Medicine, Clinical Cancer Research Center, Aalborg University Hospital, Hobrovej 18-22, DK-9000, Aalborg, Denmark;Department of Nuclear Medicine, Clinical Cancer Research Center, Aalborg University Hospital, Hobrovej 18-22, DK-9000, Aalborg, Denmark;Department of Clinical Medicine, Aalborg University, Sdr. Skovvej 11, DK-9000, Aalborg, Denmark;Department of Urology, Aalborg University Hospital, Reberbansgade 15, DK-9000, Aalborg, Denmark;

关键词: Positron emission tomography/computed tomography;    F-fluoride;    Planar bone scintigraphy;    Bone metastases;    Prostate cancer;   

DOI  :  10.1186/s12885-016-2047-1

 received in 2015-01-02, accepted in 2016-01-04,  发布年份 2016

来源: Springer

【 摘 要 】

BackgroundFor decades, planar bone scintigraphy has been the standard practice for detection of bone metastases in prostate cancer and has been endorsed by recent oncology/urology guidelines. It is a sensitive method with modest specificity. 18F-fluoride positron emission tomography/computed tomography has shown improved sensitivity and specificity over bone scintigraphy, but because of methodological issues such as retrospective design and verification bias, the existing level of evidence with 18F-fluoride positron emission tomography/computed tomography is limited. The primary objective is to compare the diagnostic properties of 18F-fluoride positron emission tomography/computed tomography versus bone scintigraphy on an individual patient basis.Methods/DesignOne hundred forty consecutive, high-risk prostate cancer patients will be recruited from several hospitals in Denmark. Sample size was calculated using Hayen’s method for diagnostic comparative studies. This study will be conducted in accordance with recommendations of standards for reporting diagnostic accuracy studies. Eligibility criteria comprise the following: 1) biopsy-proven prostate cancer, 2) PSA ≥50 ng/ml (equals a prevalence of bone metastasis of ≈ 50 % in the study population on bone scintigraphy), 3) patients must be eligible for androgen deprivation therapy, 4) no current or prior cancer (within the past 5 years), 5) ability to comply with imaging procedures, and 6) patients must not receive any investigational drugs. Planar bone scintigraphy and 18F-fluoride positron emission tomography/computed tomography will be performed within a window of 14 days at baseline. All scans will be repeated after 26 weeks of androgen deprivation therapy, and response of individual lesions will be used for diagnostic classification of the lesions on baseline imaging among responding patients. A response is defined as PSA normalisation or ≥80 % reduction compared with baseline levels, testosterone below castration levels, no skeletal related events, and no clinical signs of progression. Images are read by blinded nuclear medicine physicians. The protocol is currently recruiting.DiscussionTo the best of our knowledge, this is one of the largest prospective studies comparing 18F-fluoride positron emission tomography/computed tomography and bone scintigraphy. It is conducted in full accordance with recommendations for diagnostic accuracy trials. It is intended to provide valid documentation for the use of 18F-fluoride positron emission tomography/computed tomography for examination of bone metastasis in the staging of prostate cancer.

【 授权许可】

CC BY   
© Fonager et al. 2016