Phase I/II Hypofractionated Radiotherapy for Prostate Cancer

Inclusion Criteria

• •Histologically proven adenocarcinoma of the prostate.
• •Stage ≤ T2b disease, as defined by 1997 American Joint Committee on Cancer (AJCC) classification
• •Predicted risk of lymph node involvement (by standard nomograms) of 15% or less (24), OR histologically negative pelvic nodes
• •Gleason score ≤ 7
• •No evidence of distant metastasis
• •Age 18+
• •Informed consent signed in accordance with institutional protocol
• •Pretreatment evaluations must be completed as specified in Section 7.0.
• •ECOG performance status 0-1
• •No previous or concurrent cancers, other than localized basal cell or squamous cell skin carcinoma, unless continually disease free for at least 5 years
• •No prior pelvic irradiation, prostate brachytherapy, or bilateral orchiectomy
• •Gonadotropin-releasing hormone agonist (GnRH-a) use permitted (maximum of 6 months duration). Anti-androgen therapy permitted concurrently with GnRH-a.
• •No previous or concurrent cytotoxic chemotherapy
• •No radical surgery or cryosurgery for prostate cancer
• •The absence of any co-morbid medical condition which would constitute a contraindication for radical radiotherapy
• •The absence of serious concurrent illness of psychological, familial, sociological, geographical or other concomitant conditions which do not permit adequate follow-up and compliance with the study protocol.
• •No current use of anticoagulation therapy, other than aspirin.