***TASK*** the task is to summarize an input biomedical literature in six sentences 
    ***INPUT*** the input is a biomedical literature 
    ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences 
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    ***EXAMPLES*** 
    Input: AIMS The treatment of intermediate- to high-risk prostate cancer with  radical radiotherapy  is usually in combination with neoadjuvant and rogen deprivation therapy . The aim of the present trial was to investigate whether degarelix achieves comparable efficacy with that of goserelin plus bicalutamide as neoadjuvant therapy before radiotherapy . MATERIAL S AND METHODS The study was a r and omised , parallel-arm , active-controlled , open-label trial in 244 men with a UICC prostate cancer TNM category T2b-T4 , N0 , M0 , Gleason score ≥7 , or prostate-specific antigen ≥10 ng/ml and a total prostate volume > 30 ml , who were scheduled to undergo radical radiotherapy and in whom neoadjuvant and rogen deprivation therapy was indicated . Eligible patients received treatment with either monthly degarelix ( 240/80 mg ) or goserelin ( 3.6 mg ) for 12 weeks , the latter patients also receiving bicalutamide ( 50 mg ) for 17 days initially . The primary efficacy measure was the mean percentage reduction in total prostate volume from baseline at week 12 measured by transrectal ultrasound . The severity and relief of lower urinary tract symptoms were assessed by the International Prostate Symptom Score question naire . Quality of life was assessed by the eighth question of the International Prostate Symptom Score . About 50 % of the patients had moderate to severe lower urinary tract symptoms at baseline . RESULTS The total prostate volume decreased significantly from baseline to week 12 in both treatment groups , reaching -36.0 ± 14.5 % in degarelix-treated patients and -35.3 ± 16.7 % in goserelin-treated patients ( adjusted difference : -0.3 % ; 95 % confidence interval : -4.74 ; 4.14 % ) . At the end of the therapy , more degarelix- than goserelin-treated patients reported International Prostate Symptom Score decreases of ≥3 points ( 37 % versus 27 % , P = 0.21 ) . In addition , in patients with a baseline International Prostate Symptom Score of ≥13 , the magnitude of the decrease was larger in degarelix- ( n = 53 ) versus goserelin-treated patients ( n = 17 ) ( 6.04 versus 3.41 , P = 0.06 ) . CONCLUSIONS The efficacy of degarelix in terms of prostate shrinkage is non-inferior to that of goserelin plus bicalutamide . The added benefits of degarelix in terms of more pronounced lower urinary tract symptom relief in symptomatic patients could be the reflection of differences in the direct effects on extra-pituitary receptors in the lower urinary tract [ Clinical trials.gov ID : NCT00833248 ] Introduction : No studies to date have assessed the efficacy/tolerability of degarelix in the relief of lower urinary tract symptoms ( LUTS ) secondary to prostate cancer ( PrCa ) . Methods : Patients were r and omised to degarelix 240/80 mg or goserelin 3.6 mg + bicalutamide flare protection ( G+B ) ; both treatments were administered for 3 months . The primary endpoint was change in International Prostate Symptom Score ( IPSS ) at week 12 compared with baseline . Results : This study was stopped early due to recruitment difficulties . 40 patients received treatment ( degarelix n = 27 ; G+B n = 13 ) ; most had locally advanced disease and were highly symptomatic .  Degarelix was non-inferior to G+B in reducing IPSS at week 12 in the full analysis set ( p = 0.20 ) ; the significantly larger IPSS reduction in the per- protocol analysis ( p = 0.04 ) was suggestive of superior reductions with degarelix . Significantly more degarelix patients had improved quality of life ( IPSS question ) at week 12 ( 85 vs. 46 % ; p = 0.01 ) . Mean prostate size reductions at week 12 were 42 versus 25 % for patients receiving degarelix versus G+B , respectively ( p = 0.04 ; post hoc analysis ) . Most adverse events were mild/moderate ; more degarelix patients experienced injection site reactions whereas more G+B patients had urinary tract infections/cystitis . Conclusion : In 40 men with predominantly locally advanced PrCa and highly symptomatic LUTS , degarelix was at least non-inferior to G+B in reducing IPSS at week 12 12 Background : Comparative effectiveness of the gonadotropin-releasing hormone ( GnRH ) blocker , degarelix , vs the GnRH agonist , leuprolide , was evaluated during a 1-year phase III trial ( CS21 ) ; data have been presented . We now report long-term data from an ongoing 5-year extension study ( CS21A ) . METHODS In CS21 , patients with prostate cancer ( all stages ) were r and omized to degarelix ( 240 mg for 1 month , then monthly maintenance doses of 80 mg [ n=207 ] or 160 mg [ n=202 ] ) , or leuprolide 7.5 mg/month ( n=201 ) . Leuprolide patients could receive bicalutamide . Of the 504 patients who completed the 1-year trial , 384 chose to continue in an extension study ; those on leuprolide were re-r and omized to degarelix 240/80 mg or 240/160 mg . PSA PFS was defined as time to first PSA failure ( two consecutive increases in PSA of 50 % and ≥5 ng/mL above nadir ) or death . Time for 25 % of patients to experience PSA PFS ( TTP25 % ) was analyzed using Weibull estimates . RESULTS Up to 1 year , the risk of PSA PFS was significantly lower with degarelix 240/80 mg vs leuprolide ( p=0.05 , log-rank ) . At 27.5 months ' median follow-up , hazard rate of PSA PFS significantly decreased in leuprolide patients switched to degarelix compared with before the switch ( 0.20 vs 0.08 ; p=0.003 ) . Similar improvements occurred in patients with baseline PSA > 20 ng/mL. During the first year , TTP25 % for patients with baseline PSA > 20 ng/mL was numerically longer with degarelix vs leuprolide ( 407 vs 303 days ; p=0.085 ) ; the difference was even greater when degarelix data were analyzed beyond 1 year ( 514 vs 303 days ; p=0.01 ) . CONCLUSIONS Patients receiving degarelix had a significantly lower risk of PSA failure or death vs leuprolide during the first year of treatment . After switching to degarelix , patients who initially received leuprolide experienced a significantly lower rate of PSA failure or death . In patients with baseline PSA > 20 ng/mL , TTP25 % was significantly longer for degarelix patients . These data support the durability of the significant PSA PFS benefit of degarelix vs monthly leuprolide observed during the first year and the use of degarelix as first-line and rogen deprivation therapy . [ Table : see text ] PURPOSE We assessed the cardiovascular safety profile of degarelix , a new gonadotropin-releasing hormone antagonist . MATERIAL S AND METHODS This is the first report to our knowledge on cardiovascular safety data from a completed 1-year r and omized controlled trial of leuprolide acetate vs degarelix . Outcomes considered in these analyses included the QT interval by central reading and analysis , and cardiovascular adverse events . On multivariate analyses relationships between selected baseline factors and cardiovascular events were evaluated . RESULTS There were no significant differences between treatment groups for mean change in Fridericia 's correction of QT during the trial . Markedly abnormal Fridericia 's correction of QT values ( 500 milliseconds or greater ) were observed in only a small number of subjects by treatment group , that is 2 ( less than 1 % ) in the pooled degarelix group and 2 ( 1 % ) in the leuprolide group . Supraventricular arrhythmias were the most common type of arrhythmias , affecting 2 % of subjects in the pooled degarelix group and 4 % in the leuprolide group . Other arrhythmias occurred in 1 % or less of subjects by treatment group . The most frequently reported cardiac disorder was ischemic heart disease , which occurred in 4 % of subjects treated with degarelix and 10 % of those on leuprolide . Cox proportional hazard ratio estimates for selected baseline covariates showed a significantly increased risk of cardiovascular events by age ( p=0.0459 ) and systolic blood pressure ( p=0.0061 ) . CONCLUSIONS In men with prostate cancer  degarelix and leuprolide have similar cardiovascular safety profiles . These observations suggest that the cardiovascular events associated with both agents result from hypogonadism rather than a direct drug effect The aim of the study was to compare the onset , incidence and frequency/intensity of hot flushes during and rogen-deprivation therapy with a gonadotropin-releasing hormone antagonist ( GnRH ) blocker versus an agonist using data from a r and omized Phase 3 clinical trial . In total , 610 prostate cancer patients received monthly degarelix ( s.c . , 240/80 mg , n=207 , or 240/160 mg , n=202 ) or leuprolide ( i.m . , 7.5 mg , n=201 ) for 12 months . Data on hot flushes was collected as self-reported adverse events and in a subgroup of 254 patients with electronic diaries . The onset of hot flushes was faster on degarelix versus leuprolide , and was accompanied by higher median hot flush scores during the first 3 months . However , there were no significant differences in overall incidence rates and median hot flush scores over the entire 12 months . After the third month , incidence rates dropped below 6 % , whereas prevalence rates remained constant in all the three treatment arms . In multivariate analysis , body weight and heart rate at baseline were independent predictors of hot flushes ( P<0.05 ) . Except for a more rapid onset with the GnRH antagonist , there were no major differences in the overall pattern of hot flushes between treatment options . Weight control may help to minimize the incidence of hot flushes To evaluate the efficacy and safety of degarelix , a new gonadotrophin‐releasing hormone ( GnRH ) antagonist ( blocker ) , vs leuprolide for achieving and maintaining testosterone suppression in a 1‐year phase III trial involving patients with prostate cancer OBJECTIVE To investigate the effects of baseline testosterone on testosterone control and prostate-specific antigen ( PSA ) suppression using data from a phase III trial ( CS21 ) comparing degarelix and leuprolide in prostate cancer . METHODS In CS21 , patients with histologically confirmed prostate cancer ( all stages ) were r and omized to degarelix 240 mg for 1 month followed by monthly maintenance doses of 80 or 160 mg , or leuprolide 7.5 mg/month . Patients receiving leuprolide could receive anti and rogens for flare protection . Treatment effects on testosterone and PSA reduction , testosterone surge , and microsurges were investigated in 3 baseline testosterone subgroups : < 3.5 , 3.5 - 5.0 , and > 5.0 ng/mL. Data are presented for the groups receiving degarelix 240/80 mg ( the approved dose ) and leuprolide 7.5 mg . RESULTS Higher baseline testosterone delayed castration with both treatments . However , castrate testosterone levels and PSA suppression occurred more rapidly with degarelix irrespective of baseline testosterone . With leuprolide , the magnitude of testosterone surge and microsurges increased with increasing baseline testosterone . There was no overall correlation between baseline testosterone and initial PSA decrease in either treatment group , although PSA suppression tended to be slowest with leuprolide and fastest with degarelix in the high baseline testosterone subgroup . CONCLUSION Patients with high baseline testosterone may have greater risk of tumor stimulation ( clinical flare ) and mini-flares during gonadotrophin-releasing hormone agonist treatment and so the need for flare protection with anti and rogens in these patients is obvious , especially in metastatic disease . Although higher baseline testosterone delays castration , castrate testosterone and PSA suppression occur more rapidly with degarelix , irrespective of baseline testosterone , without the need for flare protection OBJECTIVES To evaluate whether switching prostate cancer ( PCa ) patients from leuprolide to degarelix is associated with any change in the efficacy of testosterone suppression or safety profile during the first 3 months . METHODS Participants were 134 patients with histologically confirmed PCa who had completed 1 year of treatment with leuprolide 7.5 mg monthly before being switched to degarelix .  These patients were re-r and omised for the extension trial to receive a starting dose of 240 mg degarelix followed by monthly maintenance doses of either 80 ( n = 69 ) or 1 
    Output:
    
The risk for injection-site events was increased , but cardiovascular events may occur less often by using GnRH antagonist .
There is currently insufficient evidence to make firm conclusive statements on the efficacy of GnRH antagonist compared to st and ard and rogen suppression therapy for advanced prostate cancer .