Study of Hypo-fractionated Proton Radiation for Low Risk Prostate Cancer

• Radiation: Proton Radiation Hypofractionation
  Dose: 38 Gy(RBE); 7.6 GY(RBE) five days a week in 5 treatments over 1-2 weeks
  Other Name: Particle Therapy
• Radiation: Proton Radiation Standard Fractionation
  Dose: 79.2 GY(RBE); 1.8 GY(RBE) five days a week in 44 treatments over 8.5-9 weeks
  Other Name: Particle Therapy

• Proton Radiation Hypofractionation
  5 fractions (7.6 Gy(RBE) x 5)
  Intervention: Radiation: Proton Radiation Hypofractionation
• Active Comparator: Proton Radiation Standard Fractionation
  44 fractions (1.8 Gy(RBE) x 44)
  Intervention: Radiation: Proton Radiation Standard Fractionation

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.
• Patients must be at least 18 years old.
• ECOG performance status 0-1 (appendix I) documented within 90 days prior to randomization.
• IPSS score < 16.
• Patients must give IRB approved, study specific, informed consent.
• Patients must complete all mandatory tests listed in section 4.0 within the specified time frames.
• Patients 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. However, 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, 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).