OBJECTIVE:To prospectively determine the prognostic value of the bone scan index (BSI) for time to development of castration-resistant prostate cancer (CRPC) in consecutive, hormone-naïve patients with newly diagnosed prostate cancer. PATIENTS AND METHODS:Eligible patients participated in a prospective, observational, multicenter study of the value of bone scintigraphy (BS) at staging. BSI was determined using the EXINI BoneBSI software in 208 consecutive patients undergoing androgen deprivation therapy. The presence or absence of bone metastases at staging was classified by BS with or without supplementary imaging. Follow-up was performed >5 years after including the last patient. RESULTS:During follow-up, 149 of the 208 patients (72%) were diagnosed with CRPC. Median time to CRPC was 20 months. Median follow-up time was 4.4 years in patients without CRPC. In univariate analyses, presence of bone metastases (M1) (hazard ratio [HR] 3.00, 95% confidence interval [CI] 2.10-4.30), Gleason grade (HR 1.53, 95% CI 1.31-1.79), and BSI (HR 1.17, 95% CI 1.12-1.23) but not PSA significantly predicted time to CRPC (all, P < .001). The predictive values of M1 (HR 2.06), Gleason grade (HR 1.47), and BSI (HR 1.10) were confirmed in multivariate analyses. Log-rank test for equality of time to CRPC showed the significant predictive value of BSI (BSI = 0 vs 0 < BSI ≤ 1 vs BSI > 1, P < .001). In addition to routine assessment of M1 vs M0 status, BSI contributed to the predictive power. CONCLUSIONS:BSI is an independent risk factor for the time from initiation of androgen deprivation therapy to CRPC in hormone-naïve patients. The significant prognostic factors, in rank order, were M1 status, Gleason grade, and BSI.

OBJECTIVE To determine the relationship between bone pain and bone metastases in newly diagnosed prostate cancer.PATIENTS AND METHODS This prospective study of bone scintigraphy enrolled 567 consecutive patients with newly diagnosed prostate cancer. The presence of all cause bone pain, known benign bone disease, and unexplained bone pain (ie, not related to known benign bone disease) was derived from a patient questionnaire. Univariate logistic regression models (LRMs) were used to assess the relationship between individual clinical variables (all-cause bone pain, unexplained bone pain, prostate-specific antigen, Gleason grade, T stage, and age) and bone metastases. A multivariate LRM was used to assess the relationship between bone metastases and all factors in combination. Agreement between the LRMs and bone metastases was estimated by accuracy and by Cohen's..RESULTS All-cause bone pain predicted bone metastasis in univariate but not multivariate analysis. Unexplained bone pain remained an independent predictor of bone metastases in multivariate analysis (odds ratio: 4.5; P < .001). Prostate-specific antigen was the single most important predictor of bone metastases (P < .001).CONCLUSION Unexplained bone pain was a strong independent risk factor for bone metastasis. Guidelines should recommend staging bone scintigraphy in patients with unexplained bone pain, regardless of other risk factors. (C) 2016 Elsevier Inc.

Objective: 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. Materials and methods: 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. Results: 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. Conclusion: 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.

Background International guidelines uniformly suggest no routine staging of bone metastasis in patients with bone scintigraphy (BS) in low-risk prostate cancer (PCa). These recommendations are based on retrospective investigations only. In addition, BS has most often been reported as a definitive investigation with no room for equivocal cases. Objective The objective of this study was to determine the diagnostic value of BS in a large cohort of consecutive patients with newly diagnosed PCa. Design, Setting, and Participants Over a period of 1.5 years in 2008 to 2009, consecutive patients with newly diagnosed PCa were enrolled in a noninterventional, multicenter, observational study. All patients had a whole-body, planar BS. Clinical history and clinical, pathological, and biochemical data were obtained from electronic patient files and questionnaires. Outcome Measurements and Statistical Analysis Bone scintigraphy was classified into 4 categories as nonmalignant, equivocal, likely malignant, or multiple metastasis. The primary end point was final imaging, which was a composite end point of BS and additional CT and MRI investigations. Results and Limitations A total of 635 eligible patients were recruited. Their median prostate-specific antigen (PSA) was 15 ng/mL, median Gleason was 7, and 80% of patients had local disease (T1 or T2). The proportion of nonmalignant BS was 61%, equivocal scans 26%, and likely or definitive metastasis 13%. A total of 154 patients had additional CT or MRI investigations. The final imaging diagnosis showed a prevalence of bone metastases in 87 (13.7%) of 635 patients. No bone metastases were observed in (1) patients with PSA of less than 10 ng/mL, independently of the clinical Tstage and Gleason score (n = 212) and (2) PSA of less than 20 ng/mL if Tstage is less than T3 and Gleason score is less than 8 (n = 97). Approximately 50% of the patients enrolled in this study met these criteria. Conclusion This is the first prospective trial to demonstrate that BS can be avoided in patients with low-risk PCa.

288 Objectives International guidelines suggest no routine staging of bone metastasis in patients with bone scintigraphy (BS) in newly diagnosed prostate cancer. These recommendations are based on retrospectively investigations only. In addition, most trials have considered BS as a definitive investigation with no reporting of equivocal cases. The objective was to determine the diagnostic value of BS in a prospective study. Methods Over a period of 1.5 year consecutive patients with newly diagnosed prostate cancer were enrolled in a prospective, non-interventional, multi-center study. All patients had a whole-body, planar BS which was classified into four categories as non-malignant, equivocal, likely malignant, or multiple metastasis. The primary endpoint was final imaging, which was a composite endpoint of BS and additional CT and MRI investigations. Results A total of 635 eligible patients were recruited from 3 sites. The median PSA was 15 ng/mL, median Gleason was 7, and 80% of patients had local disease (T1 or T2). The proportion of non-malignant BS was 61%, equivocal scans 26%, and likely or definitive metastasis 13%. A total of 154 patients had additional CT or MR investigations. The final imaging diagnosis showed a prevalence of bone metastases in 87/635 patients (13.7%). No bone metastasis were observed in 1) Patients with PSA Conclusions This is the first prospective trial to shown that BS can be avoided in patients with low grade prostate cancer.