Hypofractionated Proton Beam Therapy for Localized Prostate Cancer

Proton Therapy:

If you are eligible and agree to take part in this study, proton beam treatments will be
delivered 2-3 days per week until you have received a total of 15 treatments.

You will receive proton beam therapy to the prostate. Your doctor will place 2-3 small tissue
markers (about the size of grain of rice) into your prostate to help guide the proton
therapy. Anesthesia is not needed for this procedure. For each treatment, you will lie on a
treatment table for about 20-30 minutes.

Study Visits:

During proton therapy you will talk with your doctor about how you are feeling 1 time every
week.

During your last week of proton therapy you will complete the questionnaire.

For the first 24 months after proton therapy every 6-12 months, blood (about 2 tablespoons)
will be drawn to check your PSA levels and you will complete the questionnaire. How often
these visits occur will be up to the study doctor.

At 36, 48, and 60 months after proton therapy, blood (about 2 tablespoons) will be drawn to
check your PSA levels and you will be asked to complete the questionnaire.

You may be able to have the blood draws to check your PSA levels as listed above at a
location near your home. The study staff will tell you more about this option.

After proton beam therapy ends, if the study doctor thinks it is needed, you will have a
digital rectal exam, an MRI, a bone scan, and/or a standard prostate biopsy to check the
status of the disease.

Length of Study:

You will no longer be able to take part in this study if the disease gets worse, if
intolerable side effects occur, or if you are unable to follow study directions.

Your participation in this study will end 60 months after you complete proton therapy. Your
doctor will continue to provide all necessary medical care after your participation has
ended.

This is an investigational study. Proton beam therapy is delivered using an FDA approved and
commercially available method. The alternative schedules of proton beam therapy are
investigational.

Up to 200 participants will be enrolled in this study. All will take part at MD Anderson.

Inclusion Criteria:

1. Histologically confirmed diagnosis of adenocarcinoma of the prostate within one year
of study entry. Evaluation can happen outside of MD Anderson as long as histological
confirmation takes place at MD Anderson.

2. History/physical examination with digital rectal examination of the prostate within 90
days prior to registration

3. Histological evaluation of prostate biopsy with assignment of a Gleason score to the
biopsy material demonstrating Gleason score 2-7 within 365 days of registration.

4. Clinical stage T1-2b (AJCC 7th edition) and PSA <20 ng/mL within 90 days prior to
registration. PSA should not be obtained within 10 days after prostate biopsy.

5. Zubrod Performance Status 0-1 within 90 days prior to registration

6. Age greater than or equal to 18 years

7. Patient must be able to provide study-specific informed consent prior to study entry.

8. Willingness and ability to complete the EPIC questionnaire

Exclusion Criteria:

1. Prior or concurrent invasive malignancy (except non-melanomatous skin cancer or
lymphomatous/hematogenous malignancy) unless continually disease free for a minimum of
5 years

2. Evidence of distant metastases

3. Regional lymph node involvement

4. Previous prostatectomy, cryosurgery, or HIFU for prostate cancer

5. Previous pelvic radiation or prostate brachytherapy

6. Active and severe medical co-morbidity defined as follows: 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, hepatic
insufficiency resulting in clinical jaundice, active inflammatory bowel disease
(Crohn's disease or ulcerative colitis), diagnosed connective tissue disorder, or
congenital coagulation defects (Patients on medical therapy with coumadin or other
blood thinning agents are eligible for participation.)