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document
Final Report of the Intergroup Randomized Study of Combined Androgen-Deprivation Therapy Plus Radiotherapy Versus Androgen-Deprivation Therapy Alone in Locally Advanced Prostate Cancer . PURPOSE We have previously reported that radiotherapy ( RT ) added to androgen-deprivation therapy ( ADT ) improves survival in men with locally advanced prostate cancer . Here , we report the prespecified final analysis of this randomized trial . PATIENTS AND METHODS NCIC Clinical Trials Group PR.3/Medical Research Council PR07/Intergroup T94-0110 was a randomized controlled trial of patients with locally advanced prostate cancer . Patients with T3-4 , N0/Nx , M0 prostate cancer or T1-2 disease with either prostate-specific antigen ( PSA ) of more than 40 μg/L or PSA of 20 to 40 μg/L plus Gleason score of 8 to 10 were randomly assigned to lifelong ADT alone or to ADT+RT . The RT dose was 64 to 69 Gy in 35 to 39 fractions to the prostate and pelvis or prostate alone . Overall survival was compared using a log-rank test stratified for prespecified variables . RESULTS One thousand two hundred five patients were randomly assigned between 1995 and 2005 , 602 to ADT alone and 603 to ADT+RT . At a median follow-up time of 8 years , 465 patients had died , including 199 patients from prostate cancer . Overall survival was significantly improved in the patients allocated to ADT+RT ( hazard ratio [ HR ] , 0.70 ; 95 % CI , 0.57 to 0.85 ; P < .001 ) . Deaths from prostate cancer were significantly reduced by the addition of RT to ADT ( HR , 0.46 ; 95 % CI , 0.34 to 0.61 ; P < .001 ) . Patients on ADT+RT reported a higher frequency of adverse events related to bowel toxicity , but only two of 589 patients had grade 3 or greater diarrhea at 24 months after RT . CONCLUSION This analysis demonstrates that the previously reported benefit in survival is maintained at a median follow-up of 8 years and firmly establishes the role of RT in the treatment of men with locally advanced prostate cancer .
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Intervention_Physical
Combined Androgen-Deprivation Therapy Plus Radiotherapy
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Intervention_Physical
Androgen-Deprivation Therapy Alone
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Intervention_Physical
radiotherapy ( RT )
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Intervention_Physical
androgen-deprivation therapy ( ADT )
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Outcome_Other
Overall survival
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Outcome_Other
Overall survival
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Outcome_Adverse-effects
higher frequency of adverse events
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Outcome_Adverse-effects
bowel toxicity
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Outcome_Adverse-effects
diarrhea
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Participant_Sex
men
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Participant_Condition
locally advanced prostate cancer
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Participant_Condition
NCIC Clinical Trials Group PR.3/Medical Research Council PR07/Intergroup T94-0110
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Participant_Condition
advanced prostate cancer
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Participant_Sample-size
One thousand two hundred five patients
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Participant_Sex
men
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Participant_Condition
locally advanced prostate cancer