(18)F-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.
For 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. (18)F-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 (18)F-fluoride positron emission tomography/computed tomography is limited. The primary objective is to compare the diagnostic properties of (18)F-fluoride positron emission tomography/computed tomography versus bone scintigraphy on an individual patient basis.
One 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 (18)F-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.
To the best of our knowledge, this is one of the largest prospective studies comparing (18)F-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 (18)F-fluoride positron emission tomography/computed tomography for examination of bone metastasis in the staging of prostate cancer.
Evaluating safety and tolerability of the selective A2A receptor agonist, regadenoson, in patients referred for single photon emission computed tomography myocardial perfusion imaging (MPI).
Observational study of patients referred for MPI stress testing using a 400?µg regadenoson (Rapiscan(®)) bolus. Hemodynamic variables and severity of adverse events (AE) were recorded before, during, and after administration.
A total of 232 patients were included. One or more AE were reported in 90% of patients; the AEs were graded mostly mild to moderate in severity, resolved spontaneously, and were mainly dyspnea, headache, and chest pain. No advanced heart block or bronchospasm were seen. Transient ST-segment changes developed in 10 patients. The maximum increase in heart rate was 19?±?11 beats/minute. The mean systolic blood pressure decreased from 144 to 139?mmHg (p?
The objective was to describe regional variations in M-staging in patients with newly diagnosed prostate cancer within a Danish county and to compare clinical practice with guideline recommendations.
Data were as captured from 1) a prospective, non-interventional study counting 635 consecutive patients referred for M-staging in the 2008-2009 period at three regional hospitals within one county, and 2) a questionnaire on M-staging practice completed by the five sites performing M-staging in the same county in 2015.
All three sites referred patients for M-staging in 2008, irrespective of their risk factors. Two of the three sites maintained this practice in 2015. Furthermore, in 2015, three of five sites performed M-staging in intermediate and high-risk patients only. Planar whole-body bone scans were standard in all sites in 2008 with single photon emission computed tomography/computed tomography (SPECT/CT) being performed if required and if available. In 2015, two sites used choline positron emission tomography/CT for primary staging of high-risk patients against guideline recommendations. The use of SPECT/CT showed wide variations from "if required" to "mandatory" head-to-thigh imaging. There were notable variations between clinical practice and guidelines in 2008, and this was even more evident in 2015.
Considerable variations existed with respect to the M-staging imaging practices in prostate cancer within a single Danish county. The variation was more pronounced in 2015 than in 2008. Clinical practice conflicted in part with European and national Danish guidelines.
The aim of this study was to evaluate, using international urology and oncology guidelines, the criteria for performing bone scintigraphy (BS) in patients with newly diagnosed prostate cancer in a prospective setting with 2 years of follow-up after prostatectomy.
In a prospective setting, criteria from European and US urology and oncology guidelines were evaluated in 220 unselected patients with BS performed as a routine investigation before radical prostatectomy. A prostate-specific antigen level of 0.1 ng/ml or lower after surgery was considered successful and was used as a measure of true-negative BS.
Overall, 200 out of 220 patients (91%) experienced successful radical prostatectomy at 6 months, with a 2 year success rate of 83%. The proportion of redundant BS ranged from 56% to 89% among the guidelines, whereas the outcome after radical prostatectomy was 93% within 6 months after surgery and 86-89% after 2 years of follow-up, without significant differences among guideline recommendations.
The guidelines from the American Urological Association and the criteria recently published by the present group proposed the largest proportion of redundant BS without compromising patient-related outcome.