***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: Our objective was to evaluate the tolerability and effect of a daily soy beverage in prostate cancer patients with biochemical failure after radiotherapy . Patients with rising prostate-specific antigen ( PSA ) after radical radiation for prostate cancer were instructed to consume 500 ml of soy beverage daily for 6 mo . Tolerability of the soy beverage and compliance were assessed . PSA doubling times before and after the consumption of soy were compared . Thirty-four subjects were enrolled ; 5 withdrew before 1 mo of soy  for reasons unrelated to soy consumption . All remaining 29 subjects were included in the analysis . Mean consumption of the assigned soy beverage was 93 % . Mild gastrointestinal upset ( 38 % ) not affecting soy consumption was the commonest side effect . PSA showed a declining trend in 4 patients ( 13.8 % ) , and there was a > 100 % prolongation of PSA doubling time in 8 patients ( 27.6 % ) . However , PSA doubling time also showed a 50 % or more shortening in 5 patients ( 17.2 % ) . In our cohort of North American subjects , 6 mo of a daily soy beverage was well tolerated and was associated with a declining trend or more than 2 times prolongation of PSA doubling time in 41 % of subjects . Confirmatory studies are warranted Pomegranate has been shown to prolong PSA doubling time in early prostate cancer , but no data from a placebo controlled trial has been published yet . The objective of this study was to prospect ively evaluate the impact of pomegranate juice in patients with prostate cancer . We conducted a phase IIb , double blinded , r and omized placebo controlled trial in patients with histologically confirmed prostate cancer . Only patients with a PSA value ≥ 5ng/ml were included . The subjects consumed 500 ml of pomegranate juice or 500 ml of placebo beverage every day for a 4 week period . Thereafter , all patients received 250 ml of the pomegranate juice daily for another 4 weeks . PSA values were taken at baseline , day 14 , 28 and on day 56 . The primary endpoint was the detection of a significant difference in PSA serum levels between the groups after one month of treatment . Pain scores and adherence to intervention were recorded using patient diaries . 102 patients were enrolled . The majority of patients had castration resistant prostate cancer ( 68 % ) . 98 received either pomegranate juice or placebo between October 2008 and May 2011 . Adherence to protocol was good , with 94 patients ( 96 % ) completing the first period and 87 patients ( 89 % ) completing both periods . No grade 3 or higher toxicities occurred within the study . No differences were detected between the two groups with regard to PSA kinetics and pain scores . Consumption of pomegranate juice as an adjunct intervention in men with advanced prostate cancer does not result in significant PSA declines compared to placebo OBJECTIVES Epidemiological studies have shown significant relationships between the use of dietary components and prostate cancer incidence and mortality . Large studies of primary prevention , which confirm these findings , are desirable but costly and difficult to design . The present tertiary prevention study reports on the effect of a dietary supplement in comparison with placebo on the rate of increase of prostate-specific antigen ( PSA ) . METHODS 49 patients with a history of prostate cancer and rising PSA levels after radical prostatectomy ( n = 34 ) or radiotherapy ( n = 15 ) participated in a r and omised , double-blind , placebo-controlled crossover study of a dietary supplement . Ethical approval of the protocol was obtained . Treatment periods of 10 weeks were separated by a 4-week washout period . The supplement consisted of soy , isoflavones , lycopene , silymarin and antioxidants as main ingredients . Changes in the rate of increase of PSA ( PSA slope and doubling time ) were the primary parameters of efficacy . Analyses according to intention to treat ( ITT ) and per protocol ( PP ) were carried out . RESULTS Baseline parameters did not differ between r and omised groups . Five participants were lost to follow-up , however 46 could be evaluated in an ITT analysis . PP analysis could be performed in 42 men with at least 5 PSA measurements . Per protocol analysis showed a significant decrease in PSA slope ( p = 0.030 ) and (2)log PSA slope ( p = 0.041 ) . This translates into a 2.6 fold increase in the PSA doubling time from 445 to 1150 days for the supplement and placebo periods . No treatment-based changes in safety parameters were observed during the study . CONCLUSIONS The soy-based dietary supplement utilised in this study was shown to delay PSA progression after potentially curative treatment in a significant fashion . More extensive studies of the supplement may be indicated OBJECTIVES To determine whether supplemental amounts of soy isoflavone ( genistein-rich extract ) would lower prostate-specific antigen ( PSA ) levels more than 50 % in patients with prostate cancer ( CaP ) . METHODS A total of 62 men ( mean age 73.6 years , range 61.4 to 89.3 ) with histologically proven CaP who had two consecutive elevated PSA readings were accrued during a 13-month period . An open-label pilot study was conducted for 6 months in which the patients took capsules containing the genistein-rich extract three times daily by mouth . The subjects were in one of five groups : after radical retropubic prostatectomy ( n = 9 ) , after radiotherapy ( n = 17 ) , after both radical retropubic prostatectomy and radiotherapy ( n = 6 ) , off-cycle during hormonal therapy ( intermittent hormones ; n = 14 ) , or active surveillance ( n = 16 ) . The primary endpoint for the trial was a 50 % reduction in the PSA level at 6 months compared with before treatment . RESULTS Of the 62 men enrolled , 52 were available for evaluation at 6 months . Three patients discontinued because of adverse events ( diarrhea ) and seven because of personal choice . One of 52 patients had a more than 50 % reduction in the PSA level ( 1.9 % response , 95 % confidence interval 0.1 % to 10.3 % ) . An additional 7 patients had PSA reductions that were less than 50 % . All 8 patients with lower PSA levels at 6 months were in the active surveillance ( watchful waiting ) treatment subgroup . Repeated measure regression models allowing for correlation between initial levels and change also indicated a decline in PSA in this group compared with other groups : 0 of 52 had a complete response , 9 ( 17 % ) had a partial response , 8 ( 15 % ) had stable disease , and 35 ( 67 % ) had disease progression . In the 9 patients with a partial response , 6 had pathologic findings that were moderately differentiated , 2 had well-differentiated findings , and 1 had poorly differentiated findings . Therefore , the response in this group of patients did not appear to be driven by the Gleason score . The total testosterone level was lowered in one of the patients responding , but it was higher in five others . CONCLUSIONS A genistein-rich extract as the sole treatment for CaP did not reduce PSA levels by 50 % or more in 51 of 52 subjects . Thus , it does not appear to be an effective treatment for CaP when given alone . However , 8 of 13 evaluated patients in the active surveillance group had either no rise or a decline in PSA levels of less than 50 % . More study is warranted for those choosing active surveillance Purpose : Phytochemicals in plants may have cancer preventive benefits through antioxidation and via gene-nutrient interactions . We sought to determine the effects of pomegranate juice ( a major source of antioxidants ) consumption on prostate-specific antigen ( PSA ) progression in men with a rising PSA following primary therapy . Experimental Design : A phase II , Simon two-stage clinical trial for men with rising PSA after surgery or radiotherapy was conducted . Eligible patients had a detectable PSA > 0.2 and < 5 ng/mL and Gleason score ≤7 . Patients were treated with 8 ounces of pomegranate juice daily ( Wonderful variety , 570 mg total polyphenol gallic acid equivalents ) until disease progression . Clinical end points included safety and effect on serum PSA , serum-induced proliferation and apoptosis of LNCaP cells , serum lipid peroxidation , and serum nitric oxide levels . Results : The study was fully accrued after efficacy criteria were met . There were no serious adverse events reported and the treatment was well tolerated . Mean PSA doubling time significantly increased with treatment from a mean of 15 months at baseline to 54 months posttreatment ( P < 0.001 ) . In vitro assays comparing pretreatment and posttreatment patient serum on the growth of LNCaP showed a 12 % decrease in cell proliferation and a 17 % increase in apoptosis ( P = 0.0048 and 0.0004 , respectively ) , a 23 % increase in serum nitric oxide ( P = 0.0085 ) , and significant ( P < 0.02 ) reductions in oxidative state and sensitivity to oxidation of serum lipids after versus before pomegranate juice consumption . Conclusions : We report the first clinical trial of pomegranate juice in patients with prostate cancer . The statistically significant prolongation of PSA doubling time , coupled with corresponding laboratory effects on prostate cancer in vitro cell proliferation and apoptosis as well as oxidative stress , warrant further testing in a placebo-controlled study Increases in serum levels of prostate-specific antigen ( PSA ) occur commonly in prostate cancer after radical prostatectomy and are design ated “ biochemical recurrence . ” Because the phytochemical sulforaphane has been studied extensively as an anticancer agent , we performed a double-blinded , r and omized , placebo-controlled multicenter trial with sulforaphane in 78 patients ( mean age , 69 ± 6 years ) with increasing PSA levels after radical prostatectomy . Treatment comprised daily oral administration of 60 mg of a stabilized free sulforaphane for 6 months ( M0–M6 ) followed by 2 months without treatment ( M6–M8 ) . The study was design ed to detect a 0.012 log (ng/mL)/month decrease in the log PSA slope in the sulforaphane group from M0 to M6 . The primary endpoint was not reached . For secondary endpoints , median log PSA slopes were consistently lower in sulforaphane-treated men . Mean changes in PSA levels between M6 and M0 were significantly lower in the sulforaphane group ( + 0.099 ± 0.341 ng/mL ) than in placebo ( + 0.620 ± 1.417 ng/mL ; P = 0.0433 ) . PSA doubling time was 86 % longer in the sulforaphane than in the placebo group ( 28.9 and 15.5 months , respectively ) . PSA increases > 20 % at M6 were significantly greater in the placebo group ( 71.8 % ) than in the sulforaphane group ( 44.4 % ) ; P = 0.0163 . Compliance and tolerance were very good . Sulforaphane effects were prominent after 3 months of intervention ( M3–M6 ) . After treatment , PSA slopes from M6 to M8 remained the same in the 2 arms . Daily administration of free sulforaphane shows promise in managing biochemical recurrences in prostate cancer after radical prostatectomy . Cancer Prev Res ; 8(8 ) ; 712–9 . © 2015 AACR PURPOSE To up date eligibility and outcome measures in trials that evaluate systemic treatment for patients with progressive prostate cancer and castrate levels of testosterone . METHODS A committee of investigators experienced in conducting trials for prostate cancer defined new consensus criteria by review ing previous criteria , Response Evaluation Criteria in Solid Tumors ( RECIST ) , and emerging trial data . RESULTS The Prostate Cancer Clinical Trials Working Group ( PCWG2 ) recommends a two- objective paradigm : ( 1 ) controlling , relieving , or eliminating disease manifestations that are present when treatment is initiated and ( 2 ) preventing or delaying disease manifestations expected to occur . Prostate cancers progressing despite castrate levels of testosterone are considered castration resistant and not hormone refractory . Eligibility is defined using st and ard disease assessment s to authenticate disease progression , prior treatment , distinct clinical subtypes , and predictive models . Outcomes are reported independently for prostate-specific antigen ( PSA ) , imaging , and clinical measures , avoiding grouped categorizations such as complete or partial response . In most trials , early changes in PSA and /or pain are not acted on without other evidence of disease progression , and treatment should be continued for at least 12 weeks to ensure adequate drug exposure . Bone scans are reported as " new lesions " or " no new lesions , " changes in soft-tissue disease assessed by RECIST , and pain using vali date d scales . Defining eligibility for prevent/delay end points requires attention to estimated event frequency and /or r and om assignment to a control group . CONCLUSION PCWG2 recommends increasing emphasis on time-to-event end points ( ie , failure to progress ) as decision aids in proceeding from phase II to phase III trials . Recommendations will evolve as data are generated on the utility of intermediate end points to predict clinical benefit OBJECTIVES To report a prospect i ve trial of lycopene supplementation in biochemically relapsed prostate cancer . METHODS 
    Output:
    
Sulphoraphane , lycopene , soy isoflavones , POMx , and Pomi-T are safe and well tolerated .
There is limited evidence that they can affect PSA dynamics .