Brachytherapy for Prostatic Carcinoma Patients

If you are found to be eligible to take part in this study, you will have an ultrasound of
your prostate before brachytherapy so that the prostate can be measured and mapped and the
placement of the needles and seeds planned ahead of time. This is a 20-minute outpatient
procedure that involves placing a probe (tube) into your rectum, which takes ultrasound
pictures of the prostate to learn the size and shape. A specialized radiation plan for each
patient is made, and the exact number of needles and seeds depend on the size and shape of
the prostate. Ultrasound pictures, using the probe in the rectum, are taken before the
implant procedure so that the plan can be made.

Brachytherapy is an outpatient surgical procedure. Under general or spinal anesthesia, you
will have thin needles inserted through the skin between the anus and the scrotum. Seeds are
inserted into the prostate through the needles. An ultrasound probe (tube which sends images
of the prostate to a screen) is placed into the rectum and remains there during the procedure
to help direct the needles. After the seeds are inserted, the needles are removed. The seeds
remain permanently in the prostate. Typically, about 25 needles are inserted with about 100
seeds. The implant procedure takes about 1-2 hours in the operating room. Afterwards, you
will go to the recovery room for 1-3 hours. You will then have a computed tomography (CT)
scan after the procedure to make sure the seeds are properly placed. You will then be allowed
to return home.

After treatment, you will have a study visit in 4-6 weeks. After that first follow-up visit,
you will have follow-up visits at 4, 8, and 12 months (+/- 3 weeks) after treatment. After
that, follow-up visits are every 6 months until 5 years after treatment and then once a year
from then on (+/- 3 weeks). At these visits, you will have a physical exam. This may include
a digital rectal exam if your doctor feels that it is needed. Blood (about 3 teaspoons) will
be drawn for routine tests. You will be asked to complete 2 questionnaires about your
urinary, bowel, sexual function, and overall quality of life. The 2 questionnaires take about
30 minutes to complete in total. A CT scan of the prostate will also be performed at the
first follow-up visit after the implant to make sure the seeds are properly placed.

If blood tests show that your cancer is getting worse, a biopsy may be done after the
treatment is complete. A biopsy is done by inserting a needle through the rectum and into the
prostate. The procedure is similar to the one done to first diagnose your prostate cancer.
Six (6) to 10 samples are usually taken. The doctor will also perform an ultrasound. This is
done by placing a tube in the rectum, which shows a picture of the prostate on a screen and
is used to guide the biopsies.

You will be taken off study if your disease progresses. Otherwise, you will remain on study
indefinitely.

This is an investigational study. Brachytherapy is FDA approved. Up to 300 patients will take
part in this study. All will be enrolled at MD Anderson.

Inclusion Criteria:

1. Histologically confirmed adenocarcinoma of the prostate, clinical stage T1c - T2b
(AJCC 6th Edition), N0, M0. Lymph node evaluation by either CT or MRI.

2. Zubrod performance status 0-1.

3. Patient must be greater than or equal to 18 years of age.

4. Patients with intermediate risk prostate cancer as determined by one of the following
combinations: Gleason < 7, PSA 10-15; Gleason 7, PSA must be < 10.

5. Prostate specific antigen (PSA) prior to study entry must be less than or equal to 15
ng/ml.

6. Hormone naive.

7. Prostate volumes by TRUS less than or equal to 60 cc.

8. AUA voiding symptom scores patient.

9. Patients must sign a study-specific informed consent form prior to study entry.

Exclusion Criteria:

1. Stage < T1c, T2c, T3 or T4 disease (AJCC 6th Edition).

2. Lymph node involvement (N1).

3. Evidence of distant metastases (M1).

4. Radical surgery for carcinoma of the prostate, prior pelvic radiation, prior
chemotherapy for prostate cancer, prior TURP, prior cryosurgery, TUNA, TUMT of the
prostate.

5. Active prostatitis.