Proton Therapy vs. IMRT for Low or Intermediate Risk Prostate Cancer

Prior treatment

• Prior surgery (not including TURP), cryosurgery, radiofrequency ablation, chemotherapy or radiation for PCa
• Prior or planned androgen deprivation or bilateral orchiectomy

Other illness

• Hip prosthesis, inflammatory bowel disease or connective tissue disorder such as active scleroderma or lupus
• Individuals with a history of other malignancies are ineligible unless 1) they have been disease-free for at least 5 years OR 2) are deemed by the investigator to be at low risk for recurrence of that malignancy with no plans for adjuvant systemic chemotherapy and/or radiation therapy and have received overall principal investigator approval.
• Individuals who have AIDS (CD4 \< 200 or an AIDS-defining illness) or are HIV positive and not on HAART therapy are ineligible.
• Major medical or psychiatric illness
• Individuals with any of the following conditions are excluded from this study:
  • Unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months.
  • Transmural myocardial infarction within the last 6 months.
  • Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration.
  • Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at the time of registration
  • History of Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects within the last 12 months

Other

• Distant metastases, or clinically or pathologically involved lymph nodes confirmed by a CT scan within 365 days of study entry

• Diagnosed with histologically confirmed adenocarcinoma of the prostate based on core-biopsy within 1 year of study entry from TRUS
• Clinical stages T1c to T2c
• PSA \<20, within 6 months of study entry
• Participants who are currently receiving Dutasteride (or have received it within the last 90 days) or Finasteride (or have received it within the last 30 days) must have a PSA of ≤ 10
• Gleason score ≤6, 3 + 4 = 7, or 4 + 3 = 7
• ECOG Performance Status 0-1 as documented within 3 months prior to study entry
• Must have complete history and physical examination within 45 days of study entry and digital rectal examination of prostate within 180 days of study entry