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Jeff Michalski MD M.B.A.
Closed to Accrual
Determine whether 3D-CRT/IMRT to 79.2 Gy in 44 fractions will lead to improved overall survival in patients treated for prostate cancer compared to a group of patients treated with 3D-CRT/ IMRT to 70.2 Gy in 39 fractions.
Histologically confirmed prostate adenocarcinoma within 180 days of randomizationZubrod Performance Scale 0-1Prostatic biopsy tumor grading by the Gleason Score ClassificationOne of the following combinations of factors:• Clinical stage T1b-T2b, Gleason score 2-6, and prostate-specific antigen > =10 but < 20• Clinical stage T1b-T2b, Gleason score 7, and prostate-specific antigen < 15Clinically negative lymph nodes or histologically negative by nodal sampling or dissectionNo distant metastases (M0)No previous or concurrent invasive cancers, other than localized basal cell or squamous cell skin carcinoma, unless continually disease free for at least 5 yearsNo prior pelvic irradiation, prostate brachytherapy, or bilateral orchiectomyNo previous or concurrent cytotoxic chemotherapy for this cancerNo previous hormonal treatment (no finasteride or phytoestrogen preparation within 3 months prior to registration)- No radical surgery or cryosurgery for prostate cancer- Pretreatment evaluations must be completed as specified in Section 4.1
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