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document
Phase III trial comparing whole-pelvic versus prostate-only radiotherapy and neoadjuvant versus adjuvant combined androgen suppression : Radiation Therapy Oncology Group 9413 . PURPOSE This trial tested the hypothesis that combined androgen suppression ( CAS ) and whole-pelvic ( WP ) radiotherapy ( RT ) followed by a boost to the prostate improves progression-free survival ( PFS ) by 10 % compared with CAS and prostate-only ( PO ) RT . This trial also tested the hypothesis that neoadjuvant and concurrent hormonal therapy ( NCHT ) improves PFS compared with adjuvant hormonal therapy ( AHT ) by 10 % . MATERIALS AND METHODS Eligibility included localized prostate cancer with an elevated prostate-specific antigen ( PSA ) < or = 100 ng/mL and an estimated risk of lymph node ( LN ) involvement of 15 % . Between April 1 , 1995 , and June 1 , 1999 , 1,323 patients were accrued . Patients were randomly assigned to WP + NCHT , PO + NCHT , WP + AHT , or PO + AHT . Failure for PFS was defined as the first occurrence of local , regional , or distant disease ; PSA failure ; or death for any cause . RESULTS With a median follow-up of 59.5 months , WP RT was associated with a 4-year PFS of 54 % compared with 47 % in patients treated with PO RT ( P =.022 ) . Patients treated with NCHT experienced a 4-year PFS of 52 % versus 49 % for AHT ( P =.56 ) . When comparing all four arms , there was a progression-free difference among WP RT + NCHT , PO RT + NCHT , WP RT + AHT , and PO RT + AHT ( 60 % v 44 % v 49 % v 50 % , respectively ; P =.008 ) . No survival advantage has yet been seen . CONCLUSION WP RT + NCHT improves PFS compared with PO RT and NCHT or PO RT and AHT , and compared with WP RT + AHT in patients with a risk of LN involvement of 15 % .
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Intervention_Psychological
radiotherapy
12982
Intervention_Psychological
neoadjuvant versus adjuvant combined androgen suppression : Radiation Therapy
12983
Intervention_Psychological
androgen suppression ( CAS ) and whole-pelvic ( WP ) radiotherapy ( RT )
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Intervention_Psychological
neoadjuvant and concurrent hormonal therapy ( NCHT )
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Intervention_Psychological
adjuvant hormonal therapy ( AHT )
12986
Intervention_Psychological
NCHT
12987
Intervention_Psychological
AHT
12988
Intervention_Psychological
WP RT + NCHT , PO RT + NCHT , WP RT + AHT
12989
Intervention_Psychological
PO RT + AHT
12990
Intervention_Psychological
WP RT + NCHT
12991
Intervention_Psychological
PO RT
12992
Intervention_Psychological
NCHT
12993
Intervention_Pharmacological
PO RT
12994
Intervention_Psychological
AHT
12995
Intervention_Pharmacological
WP RT + AHT
12996
Outcome_Mortality
progression-free survival ( PFS )
12997
Outcome_Mortality
Failure for PFS
12998
Outcome_Physical
local , regional , or distant disease ; PSA failure
12999
Outcome_Mortality
death
13000
Outcome_Mortality
4-year PFS
13001
Outcome_Mortality
4-year PFS
13002
Outcome_Mortality
progression-free difference
13003
Outcome_Mortality
survival advantage
13004
Outcome_Mortality
PFS
13005
Participant_Condition
Between April 1 , 1995 , and June 1 , 1999 , 1,323 patients were accrued .