BackgroundPhysical activity has been shown to mitigate the unwanted psychological and physiological side effects of prostate cancer treatments, but sustainable exercise possibilities are limited.ObjectiveOur objective was to examine whether football in a real-world setting (i.e., local football clubs) was safe and feasible in practice and could improve quality of life, mitigate decline in muscle mass and bone density, and increase fat mass in patients with prostate cancer.MethodsIn this pragmatic, multicentre, parallel randomized controlled trial, men diagnosed with prostate cancer were recruited from five Danish urological departments. Men (N = 214) diagnosed with prostate cancer were randomly allocated, using random generated lists (block size 4–8) stratified for center and androgen-deprivation therapy status, to either 1 h of football twice weekly in a local football club or to usual care, which was a 15- to 30-min telephone session covering their options for physical activity or free-of-charge rehabilitation delivered as standard in Denmark. Allocation was concealed from the trial investigator performing the randomization, but—given the nature of the intervention—this was not possible for personnel and participants. Assessments were performed at baseline, 12 weeks, and 6 months. The primary outcome was mean change difference in prostate cancer-specific quality of life at 12 weeks. Secondary outcomes were body composition, 12-Item Short Form Health Survey (SF-12) physical and mental health, and safety—reported as fractures, falls, and serious adverse events.ResultsAttrition was 1 and 3% at 12 weeks, and 5% and 5% at 6 months for the usual care and football groups, respectively. Prostate cancer-specific quality of life was equal between groups at 12 weeks (mean difference + 1.9 points, 95% confidence interval [CI] –1.0–4.8; P = 0.20) and at 6 months (+ 0.5 points, 95% CI –2.8–3.8; P = 0.76). Fractures were equally distributed, with two fractures in the usual care group and one in the football group. Likewise, body composition outcomes were equal. Mental health improved after 6 months of football (mean difference + 2.7 points, 95% CI 0.8–4.6; P = 0.006).ConclusionsIn this trial, community-based football was a feasible exercise strategy for men with prostate cancer. Football did not improve prostate cancer-specific quality of life but did improve mental health; the clinical significance of this is unclear.Trial registrationClinicalTrials.gov: NCT02430792.Electronic supplementary materialThe online version of this article (10.1007/s40279-018-1031-0) contains supplementary material, which is available to authorized users.

ObjectiveTo compare the diagnostic accuracy of the following imaging techniques in the detection of spine metastases, using magnetic resonance imaging (MRI) as a reference: whole-body bone scintigraphy (WBS) with technetium-99m-MDP, [18F]-sodium fluoride (NaF) positron emission tomography (PET)/computed tomography (CT) and [ Patients and MethodsThe study entry criteria were biopsy-proven prostate cancer, a positive WBS consistent with bone metastases, and no history of androgen deprivation. Within 30 days of informed consent, trial scans were performed in random order. Scans were interpreted blindly for the purpose of a lesion-based analysis. The primary target variable was bone lesion (malignant/ benign) and the 'gold standard' was MRI. ResultsA total of 50 men were recruited between May 2009 and March 2012. Their mean age was 73 years, their median PSA level was 84 ng/mL, and the mean Gleason score of the tumours was 7.7. A total of 46 patients underwent all four scans, while four missed one PET/CT scan. A total of 526 bone lesions were found in the 50 men: 363 malignant and 163 non-malignant according to MRI. Sensitivity, specificity, positive and negative predictive values and accuracy were: WBS: 51, 82, 86, 43 and 61%; 54, 82, 78 and 81%; 91, 95, 75 and 87%, respectively. ConclusionsWe found that FCH-PET/CT and NaF-PET/CT were superior to WBS with regard to detection of prostate cancer bone metastases within the spine. The present results call into question the use of WBS as the method of choice in patients with hormone-naïve prostate cancer.

BackgroundPhysical exercise has been shown to be effective in relation to fatigue, aerobic fitness, and lower body strength in men with prostate cancer. However, research into the clinically relevant effects of interventions conducted in heterogeneous patient populations and in real-life clinical practice settings is warranted.Methods and findingsWe conducted a pragmatic, multicentre, parallel randomised controlled trial in 5 Danish urological departments. Recruitment began in May 2015, the first participant was randomised in June 2015, and the last participant was included in February 2017. In total, 214 men with prostate cancer were randomly assigned to either 6 months of free-of-charge football training twice weekly at a local club (football group [FG]) (n = 109) or usual care (usual care group [UG]) (n = 105), including brief information on physical activity recommendations at randomisation. Participants were on average 68.4 (SD 6.2) years old, 157 (73%) were retired, 87 (41%) were on castration-based treatment, 19 (9%) had received chemotherapy, and 41 (19%) had skeletal metastases at baseline. In this 1-year follow-up study, we evaluated the effects of community-based football training on the following outcomes: primary outcome, quality of life; secondary outcomes: continuation of football after 6 months, hip and lumbar spine bone mineral density (BMD), mental health score, fat and lean body mass, and safety outcomes, i.e., fractures, falls, and hospital admissions. Intention to treat (ITT) and per protocol (PP) analyses were conducted. No statistically significant between-group difference was observed in change in prostate-cancer-specific quality of life (ITT: 1.9 points [95% CI −1.9 to 5.8], p = 0.325; PP: 3.6 points [95% CI −0.9 to 8.2], p = 0.119). A statistically significant between-group difference was observed in change in total hip BMD, in favour of FG (0.007 g/cm2 [95% CI 0.004 to 0.013], p = 0.037). No differences were observed in change in lumbar spine BMD or lean body mass. Among patients allocated to football, 59% chose to continue playing football after the end of the 6-month intervention period. At 1-year follow-up in the PP population, FG participants had more improvement on the Mental Component Summary (2.9 [95% CI 0.0 to 5.7], p = 0.048 points higher) than UG participants, as well as a greater loss of fat mass (−0.9 kg [95% CI −1.7 to −0.1], p = 0.029). There were no differences between groups in relation to fractures or falls. Hospital admissions were more frequent in UG compared to FG (33 versus 20; the odds ratio based on PP analysis was 0.34 for FG compared to UG). There were 3 deaths in FG and 4 in UG. Main limitations of the study were the physically active control group and assessment of physical activity by means of self-report.ConclusionsIn this trial, participants allocated to football appeared to have improved hip BMD and fewer hospital admissions. Men who played football more than once a week for 1 year lost fat mass and reported improved mental health. Community-based football ...

The aim of this study was to develop a deep learning-based method for segmentation of bones in CT scans and test its accuracy compared to manual delineation, as a first step in the creation of an automated PET/ CT-based method for quantifying skeletal tumour burden. Methods: Convolutional neural networks (CNNs) were trained to segment 49 bones using manual segmentations from 100 CT scans. After training, the CNN-based segmentation method was tested on 46 patients with prostate cancer, who had undergone 18 F-choline-PET/CT and 18 F-NaF PET/CT less than three weeks apart. Bone volumes were calculated from the segmentations. The network's performance was compared with manual segmentations of five bones made by an experienced physician. Accuracy of the spatial overlap between automated CNN-based and manual segmentations of these five bones was assessed using the Sørensen-Dice index (SDI). Reproducibility was evaluated applying the Bland-Altman method. Results: The median (SD) volumes of the five selected bones were by CNN and manual segmentation: Th7 41 (3.8) and 36 (5.1), L3 76 (13) and 75 (9.2), sacrum 284 (40) and 283 (26), 7th rib 33 (3.9) and 31 (4.8), sternum 80 (11) and 72 (9.2), respectively. Median SDIs were 0.86 (Th7), 0.85 (L3), 0.88 (sacrum), 0.84 (7th rib) and 0.83 (sternum). The intraobserver volume difference was less with CNN-based than manual approach: Th7 2% and 14%, L3 7% and 8%, sacrum 1% and 3%, 7th rib 1% and 6%, sternum 3% and 5%, respectively. The average volume difference measured as ratio volume difference/mean volume between the two CNN-based segmentations was 5-6% for the vertebral column and ribs and ≤3% for other bones. Conclusion:The new deep learning-based method for automated segmentation of bones in CT scans provided highly accurate bone volumes in a fast and automated way and, thus, appears to be a valuable first step in the development of a clinical useful processing procedure providing reliable skeletal segmentation as a key part of quantification of skeletal metastases.

IntroductionAbiraterone acetate plus prednisone (AAP) and enzalutamide (ENZ) are commonly prescribed for metastatic castration-resistant prostate cancer (mCRPC). Data comparing their effects on patient-reported outcomes (PROs) from routine clinical practice are limited.MethodsAQUARiUS (NCT02813408) is an ongoing, two-cohort, prospective, observational, non-randomised, multicentre, phase IV European study assessing the effects of AAP and ENZ on PROs in 211 patients with mCRPC over 12 months. Patients receive AAP or ENZ per routine clinical practice. Data on cognition, fatigue, pain and health-related quality of life are measured using the Functional Assessment of Cancer Therapy-Cognitive Function, Brief Fatigue Inventory-Short Form, Brief Pain Inventory-Short Form and European Organization for Research and Treatment of Cancer Quality of Life-C30 questionnaires, respectively.ResultsThis 3-month analysis was conducted in 105 patients; 46 received AAP and 59 received ENZ. There were statistically significant differences in mean change from baseline favouring AAP over ENZ at months 1, 2 and 3 for perceived cognitive impairments and cognitive functioning. At each time-point, ENZ-treated patients had a significantly higher risk of experiencing clinically meaningful worsening in perceived cognitive impairments versus those receiving AAP.Statistically significant differences in mean change from baseline favouring AAP over ENZ were seen for usual level of fatigue and fatigue interference at months 2 and 3 and for current fatigue and worse level of fatigue at month 3. Differences favouring AAP versus ENZ were seen for the fatigue scale of the QLQ-C30 questionnaire (months 1 and 3). There was a significantly higher risk of clinically meaningful worsening in usual level of fatigue with ENZ versus AAP at month 3.No significant differences between cohorts were observed for pain (BPI-SF) at any time-point.ConclusionThis analysis suggests more favourable outcomes with AAP versus ENZ for cognition and fatigue in the first 3 months of treatment initiation for mCRPC. These findings require confirmation from future analyses of data from AQUARiUS from a larger number of patients with a longer follow-up period.

What ' s known on the subject? and What does the study add? Staging of patients with prostate cancer is the cornerstone of treatment. However, after curative intended therapy a high portion of patients relapse with local and/or distant recurrence. Therefore, one may question whether surgical lymph node dissection (LND) is suffi ciently reliable for staging of these patients.Several imaging methods for primary LN staging of patients with prostate cancer have been tested. Acceptable detection rates have not been achieved by CT or MRI or for that matter with PET/CT using the most common tracer fl uoromethylcholine (FCH). Other more recent metabolic tracers like acetate and choline seem to be more sensitive for assessment of LNs in both primary staging and re-staging. However, previous studies were small. Therefore, we assessed the value of [18 F ] FCH PET/CT for primary LN staging in a prospective study of a larger sample and with a ' blinded ' review. After a study period of 3 years and > 200 included patients, we concluded that [18 F ] FCH PET/CT did not reach an optimal detection rate compared with LND, and, therefore, it cannot replace this procedure. However, we did detect several bone metastases with [18 F ] FCH PET/CT that the normal bone scans had missed, and this might be worth pursuing. OBJECTIVES• To assess the value of [ 18 F ] fl uoromethylcholine (FCH) positron emission tomography/computed tomography (PET/CT) for lymph node (LN) staging of prostate cancer.• To evaluate if FCH PET/CT can replace LN dissection (LND) for LN staging of prostate cancer, as about one-third of patients with prostate cancer who receive intended curative therapy will have recurrence, one reason being undetected LN involvement. PATIENTS AND METHODS• From January 2008 to December 2010, 210 intermediate-or high-risk patients had a FCH PET/CT scan before regional LND.• After dissection, the result of histological examination of the LNs (gold standard) was compared with the result of FCH PET/CT obtained by ' blinded review ' .• Sensitivity, specifi city, positive (PPV), and negative predictive values (NPV) of FCH PET/CT were measured for detection of LNe metastases. RESULTS• Of the 210 patients, 76 (36.2%) were in the intermediate-risk group and 134 (63.8%) were in the high-risk group. A medium (range) of 5 (1 -28) LNs were removed per patient.• Histological examination of removed LNs showed metastases in 41 patients. Sensitivity, specifi city, PPV, and NPV of FCH PET/CT for patient-based LN staging were 73.2%, 87.6%, 58.8% and 93.1%, respectively.• Corresponding values for LN-based analyses were 56.2%, 94.0%, 40.2%, and 96.8%, respectively.• The mean diameter of the true positive LN metastases was signifi cantly larger than that of the false negative LNs (10.3 vs 4.6 mm; P < 0.001).• In addition, FCH PET/CT detected a high focal bone uptake, consistent with bone metastases, in 18 patients, 12 of which had histologically benign LNs. CONCLUSIONS• Due to a relatively low sensitivity and a correspondingly rather low PPV, FCH PET/ CT i...

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Background Skeletal metastatic disease excludes many cancer patients from participating in exercise and physical activity due to safety concerns. Empirical evidence from high-quality trials is warranted to guide clinicians and patients. Objective To evaluate the safety and potential benefits of high-impact aerobic exercise in patients with prostate cancer with skeletal metastases. Design Exploratory subgroup analysis of a pragmatic, multicentre, parallel randomised controlled trial. Setting The trial recruited 214 patients from five hospital urological departments in Denmark. Participants Patients with prostate cancer with skeletal metastases (n = 41). Intervention Six months of football training twice weekly at a local club or usual care. Both groups received brief information on physical activity recommendations at the time of randomisation. Main Outcome(s) and Measure(s) Safety, defined as falls, fractures and hospital admissions. Effects were evaluated on the primary outcome (prostate cancer-specific quality of life) and secondary outcomes (lean body mass, fat mass, hip and spine bone mineral density, and general physical and mental health). Results The original trial comprised 214 participants, 41 of whom had skeletal metastases at enrolment. Of these, 22 were allocated to football and 19 to usual care. The trial retention rate was 95% at 12 weeks and 88% at 6 months. Football participants attended 13 sessions on average at 12 weeks and 23 at 6 months. There were two falls, one in each group after 6 months, and no fractures. There were four unplanned hospital admissions in the study period, all four in the usual care group. Statistically significant between-group difference was observed in the primary outcome change in prostate cancer-specific quality of life at 12 weeks (7.6 points [95% CI 0.5 to 15.0]; P = 0.038). No statistical changes were found in the secondary outcomes. Conclusion The analysis showed that football training was safe in patients with skeletal metastatic prostate cancer and significantly improved quality of life. Larger analyses and/or trials are warranted to confirm the safety of exercise more broadly in cancer patients with skeletal metastatic disease. Trial Registration ClinicalTrials.gov, NCT02430792. Date of registration 30 April 2015