BackgroundTo evaluate the safety and efficacy of abiraterone acetate (AA) in the “real life” clinical practice for men with chemotherapy-naïve metastatic castration-resistant prostate.MethodsA consecutive series of patients with mCRPC in 9 Italian tertiary centres treated with AA was collected. Demographics, clinical parameters, treatment outcomes and toxicity were recorded. The Brief Pain Inventory scale Q3 was tracked and patient treatment satisfaction was evaluated. Survival curves were estimated by the method of Kaplan-Meier and Cox regression and compared by the log-rank test statistic.ResultsWe included 145 patients (mean age 76.5y). All patients were on androgen deprivation therapy. Patients had prior radiotherapy, radical prostatectomy, both treatments or exclusive androgen deprivation therapy in 17%, 33%, 9% and 40%, respectively. 57% of the patients had a Gleason score higher more than 7 at diagnosis. 62% were asymptomatic patients. The median serum total PSA at AA start was 17 ng/mL (range 0,4–2100). The median exposure to AA was 10 months (range 1–35). The proportion of patients achieving a PSA decline ≥50% at 12 weeks was 49%. Distribution of patient satisfaction was 32% “greatly improved”, 38% “improved”, 24% “not changed”, 5.5% “worsened”. Grade 3 and 4 toxicity was recorded in 17/145 patients 11.7% (70% cardiovascular events, 30% critical elevation of AST/ALT levels). At the last follow-up, median progression free and overall survival were 17 and 26.5 months, respectively. Both outcomes significantly correlated with the presence of pain, patient satisfaction, PSA baseline and PSA decline.ConclusionsThe AA is effective and well tolerated in asymptomatic or slightly symptomatic mCRPC in a “real life” setting. The survival outcomes are influenced by the presence of pain, patient satisfaction, baseline PSA and PSA decline.Trial registrationThe study was retrospectively registered at ISRCTN as DOI:10.1186/ISRCTN 52513758 in date April the 30th 2016.Electronic supplementary materialThe online version of this article (10.1186/s12885-017-3755-x) contains supplementary material, which is available to authorized users.

The study will provide information on patients' quality of life and its variations over time in relation to the treatments received for the prostate cancer.

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SummaryNo conflict of interest declared. MATERIALS AND METHODSThe clinical presentation may have a wide range of symptoms. such as perineal pain, emptying phase symptoms and intermittent haemospermia, epididymitis; the physical examination may be negative and in some cases the rectal exam reveal a cystic mass in the area of seminal vescicles. Transrectal or abdominal ultrasonography, CT scan and MRI (Figures 1-1a-2-2a) are the diagnostic tools indicated for the diagnosis; seldom vesiculography and semen analysis may be useful in cases with ejaculatory duct obstruction. Uroflussometry may show obstruction and endoscopic view can show bulging of the bladder wall with dislocation of the ureteric virtual orifice, in cases with large cysts. ROBOTIC TECHNIQUEA standard transperitoneal approach could be carried with six trocars in "W" configuration if a four arms robot is used, but four or five access are also described. Moderate Trendelemburg position was obtained. The bladder was drained with a Foley catheter. The posterior surface of the bladder was approached by transverse peritoneal incision between the bladder and the rectum and a cleavage plane was developed. Left vas deferens, seminal vesicle and cyst were identified (Figures 3-3a). Then the cyst was gently dissected from the bladder wall, resected and the communication with the seminal vesicle closed with 4/0 absorbable suture (Figures 4-4a). The peritoneal layers were sutured and no drain was left.No complications were observed. Foley catheter was removed on day one. Postoperative hospital stay was two days. After one year follow-up total relief of symptoms without complications was shown.CT scan and postoperative flowmetry showed normal findings.