Clinical Trials

Inclusion Criteria

• Histologically confirmed prostate adenocarcinoma within 365 days prior to randomization
• History/physical examination with digital rectal examination of the prostate and baseline toxicity assessment within 90 days prior to randomization
• Histological evaluation of prostate biopsy with assignment of a Gleason score to the biopsy material
  • Gleason score must be in the range of 2-6
  • > 6 cores are strongly recommended
• PSA values < 10 ng/ml within 90 days prior to randomization
  • Either done prior to biopsy or at least 21 days after prostate biopsy
• Clinical stages T1a-T2a N0 M0 (AJCC Criteria 7th Ed.)
  • Staging must be done by treating investigator
• No pelvic lymph nodes > 1.5 cm in greatest dimension unless the enlarged lymph node is biopsied and negative
• Must be at least 18 years old
• ECOG performance status 0-1 (appendix I) documented within 90 days prior to randomization
• IPSS score < 16
• Must give IRB approved, study specific, informed consent
• Must complete all mandatory tests listed in section 4.0 within the specified time frames
• Must be able to start treatment within 56 days of randomization

Exclusion Criteria

• Previous prostate cancer surgery to include prostatectomy, hyperthermia and cryosurgery
• Previous pelvic radiation for prostate cancer
• Androgen deprivation therapy prior to radiation is allowed 
  • It is not acceptable if continued during radiation or as adjuvant therapy
• Active rectal diverticulitis, Crohn's disease affecting the rectum, or ulcerative colitis
• Prior systemic chemotherapy for prostate cancer
• History of proximal urethral stricture requiring dilatation
• Current and continuing anticoagulation with warfarin sodium (Coumadin, heparin, low-molecular weight heparin, clopidogrel bisulfate (Plavix)or equivalent) unless it can be stopped to manage treatment related toxicity, to have a biopsy if needed, or for marker placement
• Any major medical, addictive or psychiatric illnesses which would affect the consent process, the completion of treatment and/or interfere with follow-up
  • Consent by legal authorized representative is not permitted in this study
• Evidence of any other cancer within the past 5 years and < 50% probability of a 5 year survival
  • Prior or concurrent diagnosis of basal cell or non-invasive squamous cell cancer of the skin is allowed