***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 
    ***DOCUMENTATION*** 
    ***EXAMPLES*** 
    Input: BACKGROUND Combination therapy with dutasteride and tamsulosin provides significantly greater benefit than either monotherapy for various patient-reported outcomes in men with moderate-to-severe lower urinary tract symptoms ( LUTS ) due to benign prostatic hyperplasia ( BPH ) and prostatic enlargement . OBJECTIVE To investigate whether combination therapy is more effective than either monotherapy in reducing the relative risk for acute urinary retention ( AUR ) , BPH-related surgery , and BPH clinical progression over 4 yr in men at increased risk of progression . DESIGN , SETTING , AND PARTICIPANTS The Combination of Avodart and Tamsulosin ( CombAT ) study was a 4-yr , multicenter , r and omised , double-blind , parallel-group study in 4844 men > or = 50 yr of age with a clinical diagnosis of BPH , International Prostate Symptom Score > or = 12 , prostate volume > or = 30 cm(3 ) , prostate-specific antigen 1.5 - 10 ng/ml , and maximum urinary flow rate ( Q(max ) ) > 5 and < or = 15 ml/s with minimum voided volume > or = 125 ml . INTERVENTION Oral daily tamsulosin , 0.4 mg ; dutasteride , 0.5 mg ; or a combination of both . MEASUREMENTS The 4-yr primary end point was time to first AUR or BPH-related surgery . Secondary end points included BPH clinical progression , symptoms , Q(max ) , prostate volume , safety , and tolerability . RESULTS AND LIMITATIONS Combination therapy was significantly superior to tamsulosin monotherapy but not dutasteride monotherapy at reducing the relative risk of AUR or BPH-related surgery . Combination therapy was also significantly superior to both monotherapies at reducing the relative risk of BPH clinical progression . Combination therapy provided significantly greater symptom benefit than either monotherapy at 4 yr . Safety and tolerability of combination therapy was consistent with previous experience with dutasteride and tamsulosin monotherapies , with the exception of an imbalance in the composite term of cardiac failure among the three study arms . The lack of placebo control is a study limitation . CONCLUSIONS The 4-yr CombAT data provide support for the long-term use of dutasteride and tamsulosin combination therapy in men with moderate-to-severe LUTS due to BPH and prostatic enlargement . CLINICAL TRIALS.GOV IDENTIFIER : NCT00090103 ( http://www . clinical trials.gov/ct2/show/NCT00090103 ) BACKGROUND We conducted a study to determine whether dutasteride reduces the risk of incident prostate cancer , as detected on biopsy , among men who are at increased risk for the disease . METHODS In this 4-year , multicenter , r and omized , double-blind , placebo-controlled , parallel-group study , we compared dutasteride , at a dose of 0.5 mg daily , with placebo .  Men were eligible for inclusion in the study if they were 50 to 75 years of age , had a prostate-specific antigen ( PSA ) level of 2.5 to 10.0 ng per milliliter , and had had one negative prostate biopsy ( 6 to 12 cores ) within 6 months before enrollment . Subjects underwent a 10-core transrectal ultrasound-guided biopsy at 2 and 4 years . RESULTS Among 6729 men who underwent a biopsy or prostate surgery , cancer was detected in 659 of the 3305 men in the dutasteride group , as compared with 858 of the 3424 men in the placebo group , representing a relative risk reduction with dutasteride of 22.8 % ( 95 % confidence interval , 15.2 to 29.8 ) over the 4-year study period ( P<0.001 ) . Overall , in years 1 through 4 , among the 6706 men who underwent a needle biopsy , there were 220 tumors with a Gleason score of 7 to 10 among 3299 men in the dutasteride group and 233 among 3407 men in the placebo group ( P=0.81 ) . During years 3 and 4 , there were 12 tumors with a Gleason score of 8 to 10 in the dutasteride group , as compared with only 1 in the placebo group ( P=0.003 ) . Dutasteride therapy , as compared with placebo , result ed in a reduction in the rate of acute urinary retention ( 1.6 % vs. 6.7 % , a 77.3 % relative reduction ) . The incidence of adverse events was similar to that in studies of dutasteride therapy for benign prostatic hyperplasia , except that in our study , as compared with previous studies , the relative incidence of the composite category of cardiac failure was higher in the dutasteride group than in the placebo group ( 0.7 % [ 30 men ] vs. 0.4 % [ 16 men ] , P=0.03 ) . CONCLUSIONS Over the course of the 4-year study period , dutasteride reduced the risk of incident prostate cancer detected on biopsy and improved the outcomes related to benign prostatic hyperplasia . ( Clinical Trials.gov number , NCT00056407 . BACKGROUND Benign prostatic hyperplasia is a progressive , and rogen-dependent disease result ing in enlargement of the prostate gl and and urinary obstruction . Preventing the conversion of testosterone to its tissue-active form , dihydrotestosterone , by inhibiting the enzyme 5 alpha-reductase could decrease the action of and rogens in their target tissues ; in the prostate the result might be a decrease in prostatic hyperplasia and therefore in symptoms of urinary obstruction . METHODS In a double-blind study , we evaluated the effect of two doses of finasteride ( 1 mg and 5 mg ) and placebo , each given once daily for 12 months , in 895 men with prostatic hyperplasia .  Urinary symptoms , urinary flow , prostatic volume , and serum concentrations of dihydrotestosterone and prostate-specific antigen were determined periodically during the treatment period . RESULTS As compared with the men in the placebo group , the men treated with 5 mg of finasteride per day had a significant decrease in total urinary-symptom scores ( P less than 0.001 ) , an increase of 1.6 ml per second ( 22 percent , P less than 0.001 ) in the maximal urinary-flow rate , and a 19 percent decrease in prostatic volume ( P less than 0.001 ) . The men treated with 1 mg of finasteride per day did not have a significant decrease in total urinary-symptom scores , but had an increase of 1.4 ml per second ( 23 percent ) in the maximal urinary-flow rate , and an 18 percent decrease in prostatic volume . The men given placebo had no changes in total urinary-symptom scores , an increase of 0.2 ml per second ( 8 percent ) in the maximal urinary-flow rate , and a 3 percent decrease in prostatic volume . The frequency of adverse effects in the three groups was similar , except for a higher incidence of decreased libido , impotence , and ejaculatory disorders in the finasteride-treated groups . CONCLUSIONS The treatment of benign prostatic hyperplasia with 5 mg of finasteride per day results in a significant decrease in symptoms of obstruction , an increase in urinary flow , and a decrease in prostatic volume , but at a slightly increased risk of sexual dysfunction OBJECTIVES To evaluate prostate cancer detection and prostate-specific antigen ( PSA ) among men with benign prostatic hyperplasia treated with finasteride .  METHODS Three thous and forty men 45 to 78 years of age with PSA less than 10 ng/mL and no history of prostate cancer were r and omized in a double-blind , placebo-controlled trial to finasteride ( n = 1524 ) or placebo ( n = 1516 ) for up to 4 years . A prer and omization biopsy negative for prostate cancer was obtained in 98 % of patients with a screening PSA of 4.0 ng/mL or more , and an end-of- study biopsy was requested of all such patients without a recent second negative biopsy or a prostate cancer diagnosis . RESULTS Overall , 644 patients ( 21 % ) underwent biopsy  and 201 ( 6.6 % ) underwent transurethral resection of the prostate .  Prostate cancer was diagnosed in 4.7 % of men on finasteride and 5.1 % on placebo ( P = 0.7 ) . Elevated PSA prompted diagnosis in 35 % of cases on finasteride and 34 % on placebo . The area under the receiver operating characteristic curve for last PSA was 0.84 on finasteride and 0.79 on placebo ( P = 0.07 ) . Use of an upper limit of normal for last PSA of 2.0 ng/mL for finasteride and 4.0 ng/mL for placebo yielded similar sensitivity ( 66 % versus 70 % , P = 0.6 ) , higher specificity ( 82 % versus 74 % , P < 0.0001 ) , and a higher likelihood ratio ( 3.6 versus 2.7 , P < 0.05 ) for finasteride than for placebo . CONCLUSIONS In men treated with finasteride , multiplying PSA by 2 and using normal ranges for untreated men preserves the usefulness of PSA for prostate cancer detection OBJECTIVE To evaluate the efficacy and safety of 2 years ' treatment of moderate benign prostatic hyperplasia ( BPH ) with finasteride . DESIGN Double-blind , parallel-group , placebo-controlled , multicentre , prospect i ve r and omized study . SETTING Outpatient care in 28 centres across Canada . PARTICIPANTS Men aged 45 to 80 , in good health , with moderate BPH and no evidence of prostate cancer . A total of 613 men were entered into the study ; 472 completed the 2 years of treatment . INTERVENTION After 1 month of receiving a placebo ( run-in period ) , patients were given either finasteride ( 5 mg/d ) or a placebo for 2 years . OUTCOME MEASURES EFFICACY changes from baseline in BPH symptom scores , maximum urinary flow rates and prostate volume . SAFETY onset , course and resolution of all adverse events during the treatment period . RESULTS In the efficacy analyses the mean BPH symptom scores decreased 2.1 points ( from 15.8 to 13.7 ) in the finasteride group , as compared with a decrease of 0.7 points ( from 16.6 to 15.9 ) in the placebo group ( P < or = 0.01 ) . The maximum urinary flow rate increased by a mean of 1.4 mL/s ( from 11.1 to 12.5 mL/s ) in the finasteride group , as compared with an increase of 0.3 mL/s ( from 10.9 to 11.2 mL/s ) in the placebo group ( p < or = 0.01 ) . The mean prostate volume decreased by 21 % ( from a mean volume of 44.1 cm3 at baseline ) in the treatment group ; it increased by 8.4 % ( from a mean volume of 45.8 cm3 at baseline ) in the placebo group ( p < or = 0.01 ) . In the safety analysis , the proportion of patients who experienced any adverse event was similar in the two groups ( 81.0 % in the treatment group and 81.2 % in the placebo group ) . However , the incidence of adverse events related to sexual dysfunction were significantly higher in the finasteride group than in the placebo group ( ejaculation disorder 7.7 % v. 1.7 % and impotence 15.8 % v. 6.3 % ; p < or = 0.01 for both parameters ) . CONCLUSION Finasteride is a well-tolerated and effective alternative to watchful waiting in the treatment of moderate BPH The effects of finasteride , a potent 5 alpha-reductase inhibitor , were assessed in 750 patients with benign prostatic hyperplasia ( BPH ) in a multicenter , double-blind , placebo-controlled study . Patients were r and omized to finasteride , 1 or 5 mg , or placebo , daily for 12 months . The following changes were seen with finasteride 5 mg after 12 months : ( 1 ) Serum dihydrotestosterone decreased by 62 % compared to no change with placebo ( P < 0.001 ) ; ( 2 ) serum prostate-specific antigen ( PSA ) decreased by 46 % compared to no change with placebo ( P < 0.001 ) ; ( 3 ) prostate volume was reduced by 22 % compared to a 5 % decrease with placebo ( P < 0.001 ) ; ( 4 ) maximum urinary flow rate increased by 1.7 ml/sec compared to a 0.4 ml/sec increase with placebo ( P < 0.025 ) ; ( 5 ) total urinary symptom scores decreased by 3.3 points compared to a 2.0 point decrease with placebo ( P = 0.005 ) , and ( 6 ) obstructive symptom scores decreased by 2.1 points compared to a 1.4 point decrease with placebo ( P = 0.017 ) . The effects of finasteride 1 mg were similar to 5 mg , except in urinary symptoms 
    Output:
    
• Incidences of erectile dysfunction , ejaculate volume , decreased libido , and gynaecomastia were greater with 5-α-RI vs placebo .
• 5-α-RIs reduce the risk of being diagnosed with prostate cancer among men who are screened regularly for prostate cancer .
• Information is inadequate to assess the effect of 5-α-RIs on prostate cancer or all-cause mortality .
• 5-α-RIs  increase sexual and erectile dysfunction