Proton Therapy for Low and Intermediate Risk Prostate Cancer

A Phase II Study of Hypofractionated Image Guided Proton Radiation Therapy for Low and Intermediate Risk Adenocarcinoma of the Prostate

The purpose of this trial is to give a shorter course (5 ½ weeks) of radiation that has as little side effects on normal bladder and rectal tissues as the usual longer course (8 weeks) of radiation, without decreasing the chance of killing prostate cancer cells.

Low Risk - Total of 70 Gy/CGE over 28 treatments

Intermediate Risk - Total of 72.5 Gy/CGE over 29 treatments

Inclusion Criteria

• Prostate cancer.
• Gleason score 2-7.
• PSA ≤ 20 ng/ml.

Exclusion Criteria:

• Previous prostate cancer surgery or pelvic radiation.
• Prior or current chemotherapy for prostate cancer.
• Active inflammatory bowel disease (Crohn's disease, diverticulitis or ulcerative colitis) affecting the rectum.
• History of proximal urethral stricture requiring dilatation.
• History of hip replacement.
• Diabetes requiring medication.
• Prior intrapelvic surgery.
• Current and continuing anticoagulation with Warfarin sodium (Coumadin), Clopidogrel bisulfate (Plavix), enoxaparin sodium (Lovenox), or aspirin/er dipyridamole (Aggrenox).
• On Flomax (Tamsulosin), Hytrin (Terazosin) or Cardura (Doxazosin), Uroxatral (alfuzosin HCl).
• Taking Saw Palmetto or methotrexate and unable or unwilling to discontinue its use during radiation.