Intergroup (NCIC CTG, CUOG, ECOG, CALGB, SWOG) Phase III Randomized Trial Comparing Total Androgen Blockade Versus Total Androgen Blockade Plus Pelvic Irradiation in Clinical Stage T3 - 4, N0, M0 Adenocarcinoma of the Prostate

Pt must have a histological diagnosis of adenocarcinoma of the prostate w/in 6 mos of randomization. Clinical stage T3 and T4, N0 or NX, M0 OR T2, PSA greater than 40 OR T2, PSA greater than 20 and Gleason greater than/equal to 8. Gleason must be determined. If investigated, pelvic LN's must be clinically negative. CT or MRI is mandatory only in patients being treated to the prostate only (see 8.2.3 of protocol). Any node appearing greater than 1.5 cm on CT or MRI must have had a negative needle aspirate w/in 3 mos of randomization. Pt must be free of bony mets as reported on a bone scan w/in 16 wks prior to randomization. Pt must not have had a radical prostatectomy. If pt has had a LN dissection, it must be histologically negative and performed w/in 12 wks prior to randomization. Pt must be evaluated and found eligible by a radiation oncologist w/in 4 wks prior to randomization. Baseline PSA must be w/in 12 wks prior to any hormone therapy (NOTE: if a TURP has been performed, the pre-randomization PSA must be obtained more than 21 days after the TURP). Pt may have rec'd prior hormone therapy during the 12 wks prior to randomization provided that: negative bone scan w/in 2 wks after start of hormone therapy, extracapsular extension remains palpable on rectal re-exam and baseline PSA w/in 12 wks prior to any hormone therapy. Pt must not have rec'd any cytotoxic anticancer therapy. Pts may have rec'd treatment w/ a 5 alpha-reductase inhibitor for BPH which must be dc'd at least 4 to 6 wks before randomization PSA level. Pts must have ECOG PS of 0-2. Pts must be less than 80 yrs of age. Pt must have completed the pre-randomization QOL assessment and be willing and able to complete future assessments. W/in 4 wks prior to randomization, pt must have HGB greater than/equal to 10 g/dL, WBC greater than/equal 2.0 x 10E3/uL, PLTS greater than/equal 100 x 10E3/uL and SGOT/SGPT, Alk Phos, Creat and Bili less than 2 x ULN.