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Impact of surgical staging in evaluating the radiotherapeutic outcome in RTOG # 77-06 , a phase III study for T1BN0M0 ( A2 ) and T2N0M0 ( B ) prostate carcinoma . PURPOSE To evaluate survival and time to metastatic disease in patients treated for localized prostatic carcinoma in a Phase III radiotherapy ( RT ) protocol , Radiation Therapy Oncology Group ( RTOG ) 77-06 . Patients with T18N0M0 ( A2 ) or T2N0M0 ( B ) disease after lymphangiogram ( LAG ) or staging laparotomy ( SL ) were randomized between prophylactic radiation to the pelvic lymph nodes and prostatic bed vs. prostatic bed alone . The outcome of both treatment arms , as well as a comparison of the LAG group , to that of the SL group , are updated . METHODS AND MATERIALS A total of 449 eligible males were entered into RTOG protocol 7706 between 1978 and 1983 . Lymph node staging was mandatory but at the physician 's discretion ; 117 ( 26 % ) patients had SL , while 332 ( 74 % ) had LAG . Follow-up was a median of 12 years and a maximum of 16 years . For those randomized to receive prophylactic pelvic lymph nodal irradiation , 45 Gy of megavoltage RT was delivered via multiple portals in 4.5-5 weeks , while all patients received 65 Gy in 6.5-8 weeks to the prostatic bed . RESULTS There was no significant difference in survival whether treatment was administered to the prostate or prostate and pelvic lymph nodes . The SL group had greater 12-year survival than the LAG group ( 48 % vs. 38 % , p = 0.02 ) . Disease-free survival was statistically significant , with 38 % for the SL group vs. 26 % for the LAG group ( p = 0.003 ) . Bone metastasis was less common in the SL group ( 14 % ) than the LAG group ( 27 % ) ( p = 0.003 ) . CONCLUSION At 12-year median follow-up , there still was no survival difference in those patients treated prophylactically to the pelvic nodes and prostatic bed vs. the prostatic bed alone . Those patients not surgically staged with only LAG for lymph node evaluation were less accurately staged , as reflected by a statistically significant reduced survival and earlier metastases .
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Intervention_Surgical
surgical staging
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Intervention_Physical
Phase III radiotherapy
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Intervention_Physical
Radiation Therapy Oncology Group
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Outcome_Mortality
survival
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Outcome_Mortality
12-year survival
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Outcome_Mortality
Disease-free survival
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Outcome_Physical
Bone metastasis