***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: PURPOSE The results of therapy in 288 men with pathologic Stage C prostate cancer who underwent radical retropubic prostatectomy ( RRP ) were analyzed to determine the effects of adjuvant therapy . METHODS AND MATERIAL S Twenty-seven of the 288 patients received preoperative neoadjuvant hormonal therapy ( leuprolide acetate ) . Postoperatively , 60 patients received  adjuvant radiotherapy ( RT ) to the prostate bed . Follow-up ranged from 3 to 83 months ( median = 32 months ) . Freedom from failure ( FFF ) was defined as maintaining a serum PSA level of < or = 0.3 ng/ml . RESULTS The FFF was 61 % at 3 years and 45 % at 5 years for the entire group . The FFF following RRP plus RT was 75 % at 3 years and 57 % at 5 years as compared to 56 % at 3 years and 40 % at 5 years for RRP without RT ( p=0.049 ) . The FFF following RRP plus neoadjuvant hormonal therapy was 58 % at 3 years and 40 % at 5 years as compared to 60 % at 3 years and 45 % at 5 years following RRP without hormonal therapy ( p=0.3 ) . In patients without seminal vesicle ( SV ) invasion , the FFF was 81 % at 3 years and 5 years for RRP plus RT as compared to 61 % at 3 years and 50 % at 5 years for RRP without RT ( p=0.01 ) . In patients with SV invasion , the FFF was 61 % at 3 years and 36 % at 5 years for RRP plus RT as compared to 44 % at 3 years and 23 % at 5 years for RRP without RT ( p=0.23 ) . The projected local control rate was 83 % at 5 years for those with RRP alone as compared to 100 % for RRP plus RT ( p=0.02 ) . Survival at 5 years was projected to be 92 % and was not significantly altered by the administration of adjuvant therapies . CONCLUSIONS Postoperative RT was associated with significantly improved local control and FFF rates , especially in patients with tumors which did not involve the seminal vesicles PURPOSE To evaluate the treatment outcome in pT3N0 patients with adenocarcinoma of the prostate treated with an elective course of postoperative irradiation ( RT ) .  METHODS AND MATERIAL S During a 22-year period , a total of 423 pT3N0 prostate cancer patients were treated at a single medical center with prostatic fossa RT , which was the only adjuvant therapy given . The patient characteristics were as follows : median age 66 years ; Stage pT3aN0 in 296 ( 70 % ) and pT3bN0 in 127 ( 30 % ) ; Gleason score 2 - 4 in 12 ( 2.8 % ) , 5 - 6 in 157 ( 37.1 % ) , 7 in 151 ( 35.7 % ) , and 8 - 10 in 100 ( 23.6 % ) ; and the median and mean preoperative prostate-specific antigen ( PSA ) level was 10 and 15.9 ng/mL , respectively .  Radiotherapy consisted of a median dose of 48 Gy delivered to the prostatic fossa and its immediate vicinity . The median follow-up was 7 years . RESULTS The 5- and 10-year actuarial survival rate was 92 % and 73 % , respectively , and the 5- and 10-year disease-free survival rate ( PSA < 0.05 ng/mL ) was 69 % and 51 % , respectively . In multivariate analysis , the Gleason score was the most important predictor for survival ( p = 0.00005 ) , and pathologic stage and Gleason score were independently predictive of disease-free survival ( p = 0.00007 and 0.0003 , respectively ) . The worst prognostic category was represented by pT3bN0 , Gleason score 7 - 10 patients who had a 5.3 times greater risk of tumor recurrence than those with pT3aN0 , Gleason score 2 - 6 . A high ( > 25 ng/mL ) preoperative PSA level was also a predictor of tumor recurrence ( p = 0.03 ) . A total of 43 patients ( 10.2 % ) developed clinical recurrence . This included 30 patients ( 7 % ) with distant metastases alone and 13 ( 3 % ) with local recurrence , which included 2 patients who also had distant disease . An additional 88 patients ( 20 % ) had PSA elevation ( > 0.05 ng/mL ) . This treatment program was well tolerated , with acute toxicity common ( 62 % ) but of no clinical significance . No late or severe toxicity was recorded . CONCLUSION Adjuvant radiotherapy , as given in this study , appears to substantially reduce the expected incidence of local tumor recurrence in pT3N0 prostate cancer patients . The treatment outcome was poor in pT3bN0 and Gleason score 7 - 10 patients , with > 80 % showing evidence of clinical or PSA recurrence at 10 years after therapy . This group should be the target of a prospect i ve trial of systemic therapy INTRODUCTION A dry run of a clinical trial ( EORTC 22911 ) is presented in which 12 centres have participated . These are the centres which have contributed the largest number of patients to the trial . MATERIAL AND METHODS Each participating centre received data from a suitable patient . Investigators were asked to plan and ' treat ' the patient according to the protocol guidelines and return the data for evaluation of compliance . RESULTS The results show that compliance to the protocol guidelines was generally good . There were a few minor deviations in the dose and fractionation schedule , in the volume reduction for the booster dose and in the dose prescription point . None of these deviations will affect the outcome of the study . The most important observation is the large inter-centre variation in target volumes . CONCLUSIONS The results of this study underlines the need for a strict definition of the target volume and the adoption of the ICRU 50 recommendations in future protocol Pathological staging and surgical margin status of  radical prostatectomy specimens are next to grading the most important prognosticators for recurrence . A central review of pathological stage and surgical margin status was performed on a series of 552 radical prostatectomy specimens of patients , participating in the European Organisation for Research and Treatment of Cancer trial 22911 . Inclusion criteria of the trial were pathological stage pT3 and /or positive surgical margin at local pathology . All specimens were totally embedded . Data of the central review were compared with those of local pathologists and related to clinical follow-up . Although a high concordance between review pathology and local pathologists existed for seminal vesicle invasion ( 94 % , κ=0.83 ) , agreement was much less for extraprostatic extension ( 57.5 % , κ=0.33 ) and for surgical margin status ( 69.4 % , κ=0.45 ) .  Review pathology of surgical margin status  was a stronger predictor of biochemical progression-free survival in univariate analysis [ hazard ratio (HR)=2.16 and p=0.0002 ] than local pathology ( HR=1.08 and p>0.1 ) . The review pathology demonstrated a significant difference between those with and without extraprostatic extension ( HR=1.83 and p=0.0017 ) , while local pathology failed to do so ( HR=1.05 and p>0.8 ) . The observations suggest that review of pathological stage and surgical margin of radical prostatectomy strongly improves their prognostic impact in multiinstitutional studies or trials 4504 Background : In 1992 , as radical prostatectomy was more frequently applied to clinical T1 - 2N0M0 prostate cancer , the EORTC has undertaken a r and omized trial of immediate post-operative treatment versus wait- and -see policy , for patients with high risk factors of local relapse on pathological specimen . We present the first efficacy results of this study . METHODS Eligible patients were ≤75 years old , WHO performance status ( PS ) 0 - 1 , had T0 - 3N0M0 PC preoperatively and ≥1 pathological risk factor of : capsule invasion , positive surgical margins , invasion of seminal vesicles .  P-XRT was 60Gy conventional external radiation delivered over 6 weeks . The trial was powered to detect a hazard ratio ( HR ) of 0.77 with 80 % power with two-sided α=0.05 with regard to clinical or biological progression-free survival . RESULTS 1005 pts were accrued by end 2001 ( P-XRT : 503 , Px : 502 ) . Median age was 65.4 years , PS 0 in 93.8 % , median pre- and post-operative PSA 12.3 and 0.2 ng/ml , respectively . All but 41pts on P-XRT were irradiated with median dose 60Gy ( range : 50 - 74 ) . The trial was review ed by an IDMC in December 2003 , after a median follow-up of 5 years and early disclosure of the trial results was recommended . Biochemical PFS ( time to twice confirmed PSA increase over nadir or first clinical failure or death ) at 5 years was 72.2 % ( CI : 67.7 - 76.8 ) on P-XRT and 51.8 % ( CI : 46.8 - 56.8 ) , HR=0.52 ( CI : 0.42 - 0.64 ) , P<0.0001 . Clinical PFS was improved from 74.8 % to 83.3 % at 5 years ( HR=0.68 , CI : 0.52 - 0.89 , P=0.004 ) . The incidence of loco-regional failure was significantly decreased ( P<0.0001 ) . Further follow-up is needed to assess the impact on distant metastases and overall survival . P-XRT is associated with an increased risk of immediate and late grade 1 - 2 side effects . Grade 3 side effect rates so far were less than 5 % in both groups . CONCLUSIONS Post-operative radiotherapy results in improved biochemical and clinical PFS . This benefit is to be weighed against the treatment side effects . Further follow-up is needed to assess the impact on overall survival . No significant financial relationships to disclose OBJECTIVES To assess the prognostic significance of a positive surgical margin in the  radical prostatectomy specimen , and to test for the presence of statistically significant interactions between surgical margin status and select pathologic stage variables . METHODS We combined prospect ively collected data from 7816 consecutive patients treated with radical prostatectomy at eight institutions . The pretreatment serum prostate-specific antigen level , pathologic Gleason sum , surgical margin status ( positive versus negative ) , presence of extracapsular extension , seminal vesicle involvement , and pelvic lymph node status were examined as predictors of the rate of biochemical progression in 5831 patients with complete records . RESULTS In multivariate Cox regression models , a positive surgical margin was associated with a 3.7-fold greater risk of progression ( P = 0.001 ) . Moreover , a statistically significant interaction was found between surgical margin status and Gleason sum 7 to 10 ( P = 0.008 ) and lymph node invasion ( P < 0.001 ) . CONCLUSIONS The presence of a positive surgical margin in the radical prostatectomy specimen has an adverse effect on prognosis . The greatest risk of biochemical recurrence may be expected if a positive surgical margin is present with Gleason sum 7 to 10 disease or lymph node invasion OBJECTIVES To assess the biochemical and clinical results of  postprostatectomy radiotherapy ( RT ) for high-risk , mostly non-rgan-confined prostate cancer . METHODS After radical prostatectomy , 66 consecutive patients received either adjuvant ( n = 29 )  or therapeutic ( n = 37 ) postoperative RT . Therapeutic RT was given for persistently elevated postoperative prostate-specific antigen ( PSA ) levels ( n = 14 ) , gradually rising PSA levels ( n = 6 ) , or clinical local recurrence ( n = 17 ) . The selection of time and referral for RT was at the discretion of the treating urologists . RESULTS The mean and median follow-up after surgery was 56.8 and 54.2 months , and after radiotherapy , it was 43.2 and 35.0 months , respectively . At 5 years , the actuarial biochemical control for the whole collective was 59.7 % ( 95 % confidence interval [ CI ] 43.3 % to 72.8 % ) . Patients treated with adjuvant RT had statistically improved biochemical control ( 85.2 % versus 34.0 % , P = 0.001 ) , but not disease-free survival ( 91 % versus 73 % , P = 0.09 ) . Advanced tumor stage ( pT3b-4 ) ( relative risk 16.6 ; 95 % CI 0.9 to 313.3 ; P = 0.01 ) , poorly differentiated histologic features ( relative risk 4.63 ;  
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One trial provided comparative grade d toxicity data ; there were no significant differences between arms in severe ( grade 3 ) gastrointestinal or genitourinary toxicity at five years .
To date , adjuvant RT has not been shown to improve overall survival compared with active surveillance .
Adjuvant RT does , however , significantly improve bPFS and is not associated with excess severe late toxicity