Abstract
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.
Highlights
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
Study objectives The primary objective of this study is to assess the diagnostic accuracy of 18F-fluoride positron emission tomography/computed tomography (PET/CT) for detection of bone metastases compared with bone scintigraphy (BS) in newly diagnosed, high risk, untreated prostate cancer patients on an individual patient basis
Early and correct diagnosis of bone metastases in prostate cancer is important for clinical decision making
Summary
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. According to current urology and oncology guidelines, planar bone scintigraphy (BS) remains the standard practice for detection of bone metastases in prostate cancer [4,5,6]. BS has a high sensitivity for detection of bone metastases in the staging of prostate cancer while its specificity is moderate. PET is associated with higher spatial resolution than gamma-camera-based BS and likely may improve diagnostic accuracy [11,12,13]
Sign-in/Register to view highlights & summary Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have
Schedule a callDisclaimer: All third-party content on this website/platform is and will remain the property of their respective owners and is provided on "as is" basis without any warranties, express or implied. Use of third-party content does not indicate any affiliation, sponsorship with or endorsement by them. Any references to third-party content is to identify the corresponding services and shall be considered fair use under The CopyrightLaw.
