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

Because no one knows which of the study options is best, you will be "randomized" into one of
the study groups: IMRT or PBT. Randomization means that you are put into a group by chance,
like flipping a coin. Neither you nor the research doctor will choose which group you will be
in. You will have an equal chance of being placed in either group. Randomization makes the
study better from a scientific point of view because it helps ensure that patients receiving
IMRT and proton therapy are similar. You will be receiving only one type of radiation, either
IMRT or PBT throughout your participation in the study.

Before you begin radiation therapy you will have a pelvic CT scan in order to design your
radiation treatment. Doctors will use information gathered from these scans to plan the best
way to deliver radiation to your tumor.

Both types of radiation therapy will be given once a day for 5 days (no weekends or holidays)
for up to 9 weeks. Both IMRT and PBT will require that you lie on a table for less than 15
minutes to obtain your treatment.

During each visit you will be asked questions about your general health and specific
questions about any problems that you might be having and any medications you might be
taking. You will also undergo a physical exam and complete some quality of life
questionnaires.

After your radiation therapy you will have follow up visits at 3,6,9,12,18,24,36,48 and 60
months.

Inclusion Criteria:

- 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

Exclusion Criteria:

- Prior surgery (not including TURP), cryosurgery, radiofrequency ablation, chemotherapy
or radiation for PCa

- Prior or planned androgen deprivation or bilateral orchiectomy

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

- 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