Proton Beam Radiation Therapy for Early Stage Adenocarcinoma of the Prostate

• Radiation therapy to the pelvis and prostate will be given once a day, 5 days a week (Monday-Friday), for 8 weeks. Each treatment takes about 10-20 minutes.
• Participants will be seen once a week for the entire 8 weeks by their study doctor to monitor and record any side effects. At the end of radiation therapy, participants will have a history and physical examination. Follow-up visits with the study doctor will be done at weeks 13 and 26 and then every 6 months for 3 years, then annually to year five.

Inclusion criteria

• Patients with previously treated adenocarcinoma of the stages T1c-T2b and Gleason of equal to or greater than 5.
• PSA values of equal to or less than 15 ng/ml must be demonstrated within two months prior to study entry and greater than 3 weeks after prostate biopsy.
• Zubrod status 0-1.
• No evidence of distant metastasis.
• No evidence of other cancer. Prior malignancy does not exclude the patient if disease free for greater than five years.

Exclusion criteria

• Clinical stages T2c or above.
• PSA greater than 15.
• Any patient with T1c disease, a PSA less than or equal to 4 and Gleason sum less than 6.
• Evidence of lymph node involvement if lymph node sampling performed.
• Previous prostate surgery to include: simple prostatectomy, TURP, hyperthermia and cryosurgery.
• Previous prostate radiation.
• Prior hormonal therapy.
• History of inflammatory bowel disease even if currently inactive or controlled on medication.
• Prior systemic chemotherapy.
• History of proximal urethral stricture requiring dilatation.
• Current and continuing anticoagulation with Coumadin or equivalent.
• Major medical or psychiatric illness